VAERS Abortion
[back] Vaccination and miscarriage (spontaneous abortion)   VAERS

 
 
 
 

Found 357 events with Symptom is Abortion spontaneous

Table Report

 
   
Age Vaccines Vaccine/Manufacturer Year of Vaccination Count Percent
< 3 Years MMR MMR / MERCK & CO. INC. 1983 1 0.28%
MMR MMR / MERCK & CO. INC. TOTAL 1 0.28%
MMR TOTAL 1 0.28%
TOTAL 1 0.28%
12-17 Years FLU FLU / SANOFI PASTEUR 2008 1 0.28%
FLU FLU / SANOFI PASTEUR TOTAL 1 0.28%
FLU TOTAL 1 0.28%
FLUN FLUN / MEDIMMUNE, INC./WYETH LABORATORIES, INC 2006 1 0.28%
FLUN FLUN / MEDIMMUNE, INC./WYETH LABORATORIES, INC TOTAL 1 0.28%
FLUN TOTAL 1 0.28%
HEP HEP / MERCK & CO. INC. 2007 1 0.28%
HEP HEP / MERCK & CO. INC. TOTAL 1 0.28%
HEP HPV4 / MERCK & CO. INC. 2007 1 0.28%
HEP HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
HEP TOTAL 2 0.56%
HEPA HEPA / UNKNOWN MANUFACTURER 2005 1 0.28%
HEPA HEPA / UNKNOWN MANUFACTURER 2008 1 0.28%
HEPA HEPA / UNKNOWN MANUFACTURER TOTAL 2 0.56%
HEPA HPV4 / MERCK & CO. INC. 2008 1 0.28%
HEPA HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
HEPA MNQ / AVENTIS PASTEUR 2005 1 0.28%
HEPA MNQ / AVENTIS PASTEUR TOTAL 1 0.28%
HEPA TD / AVENTIS PASTEUR 2005 1 0.28%
HEPA TD / AVENTIS PASTEUR TOTAL 1 0.28%
HEPA TOTAL 5 1.4%
HPV4 HEP / MERCK & CO. INC. 2007 1 0.28%
HPV4 HEP / MERCK & CO. INC. TOTAL 1 0.28%
HPV4 HEPA / UNKNOWN MANUFACTURER 2008 1 0.28%
HPV4 HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 HPV4 / MERCK & CO. INC. 2006 2 0.56%
HPV4 HPV4 / MERCK & CO. INC. 2007 10 2.8%
HPV4 HPV4 / MERCK & CO. INC. 2008 10 2.8%
HPV4 HPV4 / MERCK & CO. INC. 2009 1 0.28%
HPV4 HPV4 / MERCK & CO. INC. Unknown 2 0.56%
HPV4 HPV4 / MERCK & CO. INC. TOTAL 25 7%
HPV4 MNQ / SANOFI PASTEUR 2007 2 0.56%
HPV4 MNQ / SANOFI PASTEUR TOTAL 2 0.56%
HPV4 TDAP / GLAXOSMITHKLINE BIOLOGICALS 2007 1 0.28%
HPV4 TDAP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
HPV4 TDAP / UNKNOWN MANUFACTURER 2007 1 0.28%
HPV4 TDAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 TTOX / UNKNOWN MANUFACTURER 2007 1 0.28%
HPV4 TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 TOTAL 32 8.96%
MMR MMR / MERCK & CO. INC. 2002 1 0.28%
MMR MMR / MERCK & CO. INC. TOTAL 1 0.28%
MMR VARCEL / MERCK & CO. INC. 2002 1 0.28%
MMR VARCEL / MERCK & CO. INC. TOTAL 1 0.28%
MMR TOTAL 2 0.56%
MNQ HEPA / UNKNOWN MANUFACTURER 2005 1 0.28%
MNQ HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MNQ HPV4 / MERCK & CO. INC. 2007 2 0.56%
MNQ HPV4 / MERCK & CO. INC. TOTAL 2 0.56%
MNQ MNQ / AVENTIS PASTEUR 2005 1 0.28%
MNQ MNQ / AVENTIS PASTEUR TOTAL 1 0.28%
MNQ MNQ / SANOFI PASTEUR 2007 2 0.56%
MNQ MNQ / SANOFI PASTEUR TOTAL 2 0.56%
MNQ TD / AVENTIS PASTEUR 2005 1 0.28%
MNQ TD / AVENTIS PASTEUR TOTAL 1 0.28%
MNQ TDAP / GLAXOSMITHKLINE BIOLOGICALS 2007 1 0.28%
MNQ TDAP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
MNQ TTOX / UNKNOWN MANUFACTURER 2007 1 0.28%
MNQ TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MNQ TOTAL 9 2.52%
TD HEPA / UNKNOWN MANUFACTURER 2005 1 0.28%
TD HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD MNQ / AVENTIS PASTEUR 2005 1 0.28%
TD MNQ / AVENTIS PASTEUR TOTAL 1 0.28%
TD TD / AVENTIS PASTEUR 2005 1 0.28%
TD TD / AVENTIS PASTEUR TOTAL 1 0.28%
TD TOTAL 3 0.84%
TDAP HPV4 / MERCK & CO. INC. 2007 2 0.56%
TDAP HPV4 / MERCK & CO. INC. TOTAL 2 0.56%
TDAP MNQ / SANOFI PASTEUR 2007 1 0.28%
TDAP MNQ / SANOFI PASTEUR TOTAL 1 0.28%
TDAP TDAP / GLAXOSMITHKLINE BIOLOGICALS 2007 1 0.28%
TDAP TDAP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
TDAP TDAP / UNKNOWN MANUFACTURER 2007 1 0.28%
TDAP TDAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TDAP TOTAL 5 1.4%
TTOX HPV4 / MERCK & CO. INC. 2007 1 0.28%
TTOX HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
TTOX MNQ / SANOFI PASTEUR 2007 1 0.28%
TTOX MNQ / SANOFI PASTEUR TOTAL 1 0.28%
TTOX TTOX / UNKNOWN MANUFACTURER 2007 1 0.28%
TTOX TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TTOX TOTAL 3 0.84%
VARCEL MMR / MERCK & CO. INC. 2002 1 0.28%
VARCEL MMR / MERCK & CO. INC. TOTAL 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 2002 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. TOTAL 1 0.28%
VARCEL TOTAL 2 0.56%
TOTAL 65 18.21%
17-44 Years ANTH ANTH / EMERGENT BIOSOLUTIONS 2002 1 0.28%
ANTH ANTH / EMERGENT BIOSOLUTIONS 2003 2 0.56%
ANTH ANTH / EMERGENT BIOSOLUTIONS TOTAL 3 0.84%
ANTH ANTH / MICHIGAN DEPT PUB HLTH 1998 1 0.28%
ANTH ANTH / MICHIGAN DEPT PUB HLTH 1999 1 0.28%
ANTH ANTH / MICHIGAN DEPT PUB HLTH TOTAL 2 0.56%
ANTH TOTAL 5 1.4%
DTAP DTAP / UNKNOWN MANUFACTURER 2007 1 0.28%
DTAP DTAP / UNKNOWN MANUFACTURER 2008 1 0.28%
DTAP DTAP / UNKNOWN MANUFACTURER TOTAL 2 0.56%
DTAP HPV4 / MERCK & CO. INC. 2007 1 0.28%
DTAP HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
DTAP MMR / MERCK & CO. INC. 2008 1 0.28%
DTAP MMR / MERCK & CO. INC. TOTAL 1 0.28%
DTAP VARCEL / MERCK & CO. INC. 2007 1 0.28%
DTAP VARCEL / MERCK & CO. INC. 2008 1 0.28%
DTAP VARCEL / MERCK & CO. INC. TOTAL 2 0.56%
DTAP TOTAL 6 1.68%
DTIPV DTIPV / PASTEUR MERIEUX INST. 2007 1 0.28%
DTIPV DTIPV / PASTEUR MERIEUX INST. TOTAL 1 0.28%
DTIPV DTIPV / UNKNOWN MANUFACTURER 2007 1 0.28%
DTIPV DTIPV / UNKNOWN MANUFACTURER TOTAL 1 0.28%
DTIPV HEPA / GLAXOSMITHKLINE BIOLOGICALS 2007 1 0.28%
DTIPV HEPA / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
DTIPV HEPA / MERCK & CO. INC. 2007 1 0.28%
DTIPV HEPA / MERCK & CO. INC. TOTAL 1 0.28%
DTIPV TYP / UNKNOWN MANUFACTURER 2007 2 0.56%
DTIPV TYP / UNKNOWN MANUFACTURER TOTAL 2 0.56%
DTIPV YF / UNKNOWN MANUFACTURER 2007 1 0.28%
DTIPV YF / UNKNOWN MANUFACTURER TOTAL 1 0.28%
DTIPV TOTAL 7 1.96%
DTOX DTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
DTOX DTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
DTOX HEP / MERCK & CO. INC. 2008 1 0.28%
DTOX HEP / MERCK & CO. INC. TOTAL 1 0.28%
DTOX IPV / UNKNOWN MANUFACTURER 2008 1 0.28%
DTOX IPV / UNKNOWN MANUFACTURER TOTAL 1 0.28%
DTOX MMR / MERCK & CO. INC. 2008 1 0.28%
DTOX MMR / MERCK & CO. INC. TOTAL 1 0.28%
DTOX TTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
DTOX TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
DTOX TOTAL 5 1.4%
FLU FLU / AVENTIS PASTEUR 2003 1 0.28%
FLU FLU / AVENTIS PASTEUR 2004 1 0.28%
FLU FLU / AVENTIS PASTEUR 2005 1 0.28%
FLU FLU / AVENTIS PASTEUR TOTAL 3 0.84%
FLU FLU / EVANS VACCINES 2003 1 0.28%
FLU FLU / EVANS VACCINES TOTAL 1 0.28%
FLU FLU / GLAXOSMITHKLINE BIOLOGICALS 2005 1 0.28%
FLU FLU / GLAXOSMITHKLINE BIOLOGICALS Unknown 1 0.28%
FLU FLU / GLAXOSMITHKLINE BIOLOGICALS TOTAL 2 0.56%
FLU FLU / NOVARTIS VACCINES AND DIAGNOSTICS 2007 2 0.56%
FLU FLU / NOVARTIS VACCINES AND DIAGNOSTICS TOTAL 2 0.56%
FLU FLU / SANOFI PASTEUR 2007 1 0.28%
FLU FLU / SANOFI PASTEUR 2008 2 0.56%
FLU FLU / SANOFI PASTEUR TOTAL 3 0.84%
FLU FLU / UNKNOWN MANUFACTURER 2005 1 0.28%
FLU FLU / UNKNOWN MANUFACTURER 2008 1 0.28%
FLU FLU / UNKNOWN MANUFACTURER TOTAL 2 0.56%
FLU FLU / WYETH PHARMACEUTICALS, INC 2000 1 0.28%
FLU FLU / WYETH PHARMACEUTICALS, INC TOTAL 1 0.28%
FLU HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
FLU HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
FLU IPV / SANOFI PASTEUR 2008 1 0.28%
FLU IPV / SANOFI PASTEUR TOTAL 1 0.28%
FLU MMR / MERCK & CO. INC. 2008 1 0.28%
FLU MMR / MERCK & CO. INC. TOTAL 1 0.28%
FLU PPV / MERCK & CO. INC. 2005 1 0.28%
FLU PPV / MERCK & CO. INC. TOTAL 1 0.28%
FLU TDAP / SANOFI PASTEUR 2007 1 0.28%
FLU TDAP / SANOFI PASTEUR TOTAL 1 0.28%
FLU TDAP / UNKNOWN MANUFACTURER 2008 1 0.28%
FLU TDAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
FLU TYP / UNKNOWN MANUFACTURER 2008 1 0.28%
FLU TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
FLU TOTAL 21 5.88%
FLUN FLUN / MEDIMMUNE VACCINES, INC. 2007 2 0.56%
FLUN FLUN / MEDIMMUNE VACCINES, INC. TOTAL 2 0.56%
FLUN FLUN / MEDIMMUNE, INC./WYETH LABORATORIES, INC 2004 1 0.28%
FLUN FLUN / MEDIMMUNE, INC./WYETH LABORATORIES, INC TOTAL 1 0.28%
FLUN TOTAL 3 0.84%
HEP DTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
HEP DTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS 2002 1 0.28%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS 2004 2 0.56%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS 2005 1 0.28%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS 2006 3 0.84%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS 2008 2 0.56%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 9 2.52%
HEP HEP / MERCK & CO. INC. 2003 1 0.28%
HEP HEP / MERCK & CO. INC. 2004 1 0.28%
HEP HEP / MERCK & CO. INC. 2005 2 0.56%
HEP HEP / MERCK & CO. INC. 2006 1 0.28%
HEP HEP / MERCK & CO. INC. 2008 2 0.56%
HEP HEP / MERCK & CO. INC. TOTAL 7 1.96%
HEP HEP / SMITHKLINE BEECHAM 2000 4 1.12%
HEP HEP / SMITHKLINE BEECHAM TOTAL 4 1.12%
HEP HPV4 / MERCK & CO. INC. 2008 1 0.28%
HEP HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
HEP IPV / AVENTIS PASTEUR 2006 1 0.28%
HEP IPV / AVENTIS PASTEUR TOTAL 1 0.28%
HEP IPV / UNKNOWN MANUFACTURER 2006 1 0.28%
HEP IPV / UNKNOWN MANUFACTURER 2008 2 0.56%
HEP IPV / UNKNOWN MANUFACTURER TOTAL 3 0.84%
HEP MEN / UNKNOWN MANUFACTURER 2008 1 0.28%
HEP MEN / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEP MMR / MERCK & CO. INC. 2005 1 0.28%
HEP MMR / MERCK & CO. INC. 2008 2 0.56%
HEP MMR / MERCK & CO. INC. TOTAL 3 0.84%
HEP MMR / UNKNOWN MANUFACTURER 2008 1 0.28%
HEP MMR / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEP TD / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
HEP TD / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
HEP TDAP / SANOFI PASTEUR 2008 1 0.28%
HEP TDAP / SANOFI PASTEUR TOTAL 1 0.28%
HEP TTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
HEP TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEP TOTAL 34 9.52%
HEPA DTIPV / PASTEUR MERIEUX INST. 2007 1 0.28%
HEPA DTIPV / PASTEUR MERIEUX INST. TOTAL 1 0.28%
HEPA DTIPV / UNKNOWN MANUFACTURER 2007 1 0.28%
HEPA DTIPV / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS 2002 1 0.28%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS 2004 2 0.56%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS 2005 19 5.32%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS 2006 7 1.96%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS 2007 2 0.56%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS 2009 1 0.28%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS TOTAL 33 9.24%
HEPA HEPA / MERCK & CO. INC. 2007 4 1.12%
HEPA HEPA / MERCK & CO. INC. TOTAL 4 1.12%
HEPA HEPA / UNKNOWN MANUFACTURER 2001 1 0.28%
HEPA HEPA / UNKNOWN MANUFACTURER 2003 2 0.56%
HEPA HEPA / UNKNOWN MANUFACTURER 2004 2 0.56%
HEPA HEPA / UNKNOWN MANUFACTURER 2007 1 0.28%
HEPA HEPA / UNKNOWN MANUFACTURER TOTAL 6 1.68%
HEPA HPV4 / MERCK & CO. INC. 2007 4 1.12%
HEPA HPV4 / MERCK & CO. INC. TOTAL 4 1.12%
HEPA IPV / AVENTIS PASTEUR 2004 1 0.28%
HEPA IPV / AVENTIS PASTEUR TOTAL 1 0.28%
HEPA IPV / UNKNOWN MANUFACTURER 2005 1 0.28%
HEPA IPV / UNKNOWN MANUFACTURER 2008 1 0.28%
HEPA IPV / UNKNOWN MANUFACTURER TOTAL 2 0.56%
HEPA MNQ / SANOFI PASTEUR 2007 2 0.56%
HEPA MNQ / SANOFI PASTEUR TOTAL 2 0.56%
HEPA TD / AVENTIS PASTEUR 2003 1 0.28%
HEPA TD / AVENTIS PASTEUR 2006 1 0.28%
HEPA TD / AVENTIS PASTEUR TOTAL 2 0.56%
HEPA TD / UNKNOWN MANUFACTURER 2005 1 0.28%
HEPA TD / UNKNOWN MANUFACTURER 2008 1 0.28%
HEPA TD / UNKNOWN MANUFACTURER TOTAL 2 0.56%
HEPA TTOX / UNKNOWN MANUFACTURER 2007 1 0.28%
HEPA TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPA TYP / AVENTIS PASTEUR 2003 2 0.56%
HEPA TYP / AVENTIS PASTEUR 2004 1 0.28%
HEPA TYP / AVENTIS PASTEUR 2006 1 0.28%
HEPA TYP / AVENTIS PASTEUR TOTAL 4 1.12%
HEPA TYP / UNKNOWN MANUFACTURER 2001 1 0.28%
HEPA TYP / UNKNOWN MANUFACTURER 2005 1 0.28%
HEPA TYP / UNKNOWN MANUFACTURER 2007 2 0.56%
HEPA TYP / UNKNOWN MANUFACTURER TOTAL 4 1.12%
HEPA VARCEL / MERCK & CO. INC. 2007 1 0.28%
HEPA VARCEL / MERCK & CO. INC. TOTAL 1 0.28%
HEPA YF / AVENTIS PASTEUR 2003 1 0.28%
HEPA YF / AVENTIS PASTEUR TOTAL 1 0.28%
HEPA YF / UNKNOWN MANUFACTURER 2003 1 0.28%
HEPA YF / UNKNOWN MANUFACTURER 2007 1 0.28%
HEPA YF / UNKNOWN MANUFACTURER TOTAL 2 0.56%
HEPA TOTAL 71 19.89%
HEPAB FLU / UNKNOWN MANUFACTURER 2008 1 0.28%
HEPAB FLU / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2001 1 0.28%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2003 2 0.56%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2007 1 0.28%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2009 1 0.28%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 6 1.68%
HEPAB IPV / SANOFI PASTEUR 2008 1 0.28%
HEPAB IPV / SANOFI PASTEUR TOTAL 1 0.28%
HEPAB MMR / MERCK & CO. INC. 2008 1 0.28%
HEPAB MMR / MERCK & CO. INC. 2009 1 0.28%
HEPAB MMR / MERCK & CO. INC. TOTAL 2 0.56%
HEPAB RAB / CHIRON CORPORATION 2003 1 0.28%
HEPAB RAB / CHIRON CORPORATION TOTAL 1 0.28%
HEPAB RAB / UNKNOWN MANUFACTURER 2003 1 0.28%
HEPAB RAB / UNKNOWN MANUFACTURER 2007 1 0.28%
HEPAB RAB / UNKNOWN MANUFACTURER TOTAL 2 0.56%
HEPAB TDAP / SANOFI PASTEUR 2009 1 0.28%
HEPAB TDAP / SANOFI PASTEUR TOTAL 1 0.28%
HEPAB TDAP / UNKNOWN MANUFACTURER 2008 1 0.28%
HEPAB TDAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPAB TYP / UNKNOWN MANUFACTURER 2008 1 0.28%
HEPAB TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPAB TOTAL 16 4.48%
HPV4 DTAP / UNKNOWN MANUFACTURER 2007 1 0.28%
HPV4 DTAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 HEP / MERCK & CO. INC. 2008 1 0.28%
HPV4 HEP / MERCK & CO. INC. TOTAL 1 0.28%
HPV4 HEPA / MERCK & CO. INC. 2007 3 0.84%
HPV4 HEPA / MERCK & CO. INC. TOTAL 3 0.84%
HPV4 HEPA / UNKNOWN MANUFACTURER 2007 1 0.28%
HPV4 HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 HPV4 / MERCK & CO. INC. 2001 1 0.28%
HPV4 HPV4 / MERCK & CO. INC. 2006 6 1.68%
HPV4 HPV4 / MERCK & CO. INC. 2007 76 21.29%
HPV4 HPV4 / MERCK & CO. INC. 2008 38 10.64%
HPV4 HPV4 / MERCK & CO. INC. 2009 7 1.96%
HPV4 HPV4 / MERCK & CO. INC. Unknown 11 3.08%
HPV4 HPV4 / MERCK & CO. INC. TOTAL 139 38.94%
HPV4 MMR / MERCK & CO. INC. 2009 1 0.28%
HPV4 MMR / MERCK & CO. INC. TOTAL 1 0.28%
HPV4 MNQ / SANOFI PASTEUR 2007 2 0.56%
HPV4 MNQ / SANOFI PASTEUR TOTAL 2 0.56%
HPV4 TDAP / UNKNOWN MANUFACTURER 2009 1 0.28%
HPV4 TDAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 TTOX / UNKNOWN MANUFACTURER 2007 1 0.28%
HPV4 TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 VARCEL / MERCK & CO. INC. 2007 2 0.56%
HPV4 VARCEL / MERCK & CO. INC. TOTAL 2 0.56%
HPV4 TOTAL 152 42.58%
IPV DTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV DTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
IPV FLU / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV FLU / UNKNOWN MANUFACTURER TOTAL 1 0.28%
IPV HEP / GLAXOSMITHKLINE BIOLOGICALS 2006 2 0.56%
IPV HEP / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
IPV HEP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 3 0.84%
IPV HEP / MERCK & CO. INC. 2008 1 0.28%
IPV HEP / MERCK & CO. INC. TOTAL 1 0.28%
IPV HEPA / GLAXOSMITHKLINE BIOLOGICALS 2005 1 0.28%
IPV HEPA / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
IPV HEPA / GLAXOSMITHKLINE BIOLOGICALS TOTAL 2 0.56%
IPV HEPA / UNKNOWN MANUFACTURER 2004 1 0.28%
IPV HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
IPV HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
IPV HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
IPV IPV / AVENTIS PASTEUR 2004 1 0.28%
IPV IPV / AVENTIS PASTEUR 2006 1 0.28%
IPV IPV / AVENTIS PASTEUR TOTAL 2 0.56%
IPV IPV / SANOFI PASTEUR 2007 1 0.28%
IPV IPV / SANOFI PASTEUR 2008 1 0.28%
IPV IPV / SANOFI PASTEUR TOTAL 2 0.56%
IPV IPV / UNKNOWN MANUFACTURER 2005 1 0.28%
IPV IPV / UNKNOWN MANUFACTURER 2006 1 0.28%
IPV IPV / UNKNOWN MANUFACTURER 2008 3 0.84%
IPV IPV / UNKNOWN MANUFACTURER TOTAL 5 1.4%
IPV MEN / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV MEN / UNKNOWN MANUFACTURER TOTAL 1 0.28%
IPV MMR / MERCK & CO. INC. 2008 2 0.56%
IPV MMR / MERCK & CO. INC. TOTAL 2 0.56%
IPV MMR / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV MMR / UNKNOWN MANUFACTURER TOTAL 1 0.28%
IPV TD / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
IPV TD / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
IPV TD / SANOFI PASTEUR 2007 1 0.28%
IPV TD / SANOFI PASTEUR TOTAL 1 0.28%
IPV TD / UNKNOWN MANUFACTURER 2005 1 0.28%
IPV TD / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV TD / UNKNOWN MANUFACTURER TOTAL 2 0.56%
IPV TDAP / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV TDAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
IPV TTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
IPV TYP / AVENTIS PASTEUR 2004 1 0.28%
IPV TYP / AVENTIS PASTEUR TOTAL 1 0.28%
IPV TYP / UNKNOWN MANUFACTURER 2005 1 0.28%
IPV TYP / UNKNOWN MANUFACTURER 2008 1 0.28%
IPV TYP / UNKNOWN MANUFACTURER TOTAL 2 0.56%
IPV YF / SANOFI PASTEUR 2007 1 0.28%
IPV YF / SANOFI PASTEUR TOTAL 1 0.28%
IPV TOTAL 33 9.24%
JEV JEV / AVENTIS PASTEUR 2004 1 0.28%
JEV JEV / AVENTIS PASTEUR TOTAL 1 0.28%
JEV JEV / SANOFI PASTEUR 2008 1 0.28%
JEV JEV / SANOFI PASTEUR TOTAL 1 0.28%
JEV RAB / SANOFI PASTEUR 2008 1 0.28%
JEV RAB / SANOFI PASTEUR TOTAL 1 0.28%
JEV TYP / BERNA BIOTECH, LTD 2008 1 0.28%
JEV TYP / BERNA BIOTECH, LTD TOTAL 1 0.28%
JEV TOTAL 4 1.12%
MEN HEP / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
MEN HEP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
MEN IPV / UNKNOWN MANUFACTURER 2008 1 0.28%
MEN IPV / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MEN MEN / AVENTIS PASTEUR 2005 1 0.28%
MEN MEN / AVENTIS PASTEUR TOTAL 1 0.28%
MEN MEN / UNKNOWN MANUFACTURER 2008 1 0.28%
MEN MEN / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MEN MMR / UNKNOWN MANUFACTURER 2008 1 0.28%
MEN MMR / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MEN TD / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
MEN TD / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
MEN YF / AVENTIS PASTEUR 2005 1 0.28%
MEN YF / AVENTIS PASTEUR TOTAL 1 0.28%
MEN TOTAL 7 1.96%
MER MER / MERCK & CO. INC. 1989 1 0.28%
MER MER / MERCK & CO. INC. TOTAL 1 0.28%
MER TOTAL 1 0.28%
MMR DTAP / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR DTAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MMR DTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR DTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MMR FLU / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR FLU / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MMR HEP / GLAXOSMITHKLINE BIOLOGICALS 2005 1 0.28%
MMR HEP / GLAXOSMITHKLINE BIOLOGICALS 2008 2 0.56%
MMR HEP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 3 0.84%
MMR HEP / MERCK & CO. INC. 2008 1 0.28%
MMR HEP / MERCK & CO. INC. TOTAL 1 0.28%
MMR HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
MMR HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2009 1 0.28%
MMR HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 2 0.56%
MMR HPV4 / MERCK & CO. INC. 2009 1 0.28%
MMR HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
MMR IPV / SANOFI PASTEUR 2008 1 0.28%
MMR IPV / SANOFI PASTEUR TOTAL 1 0.28%
MMR IPV / UNKNOWN MANUFACTURER 2008 2 0.56%
MMR IPV / UNKNOWN MANUFACTURER TOTAL 2 0.56%
MMR MEN / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR MEN / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MMR MMR / MERCK & CO. INC. 2001 1 0.28%
MMR MMR / MERCK & CO. INC. 2002 1 0.28%
MMR MMR / MERCK & CO. INC. 2004 1 0.28%
MMR MMR / MERCK & CO. INC. 2005 4 1.12%
MMR MMR / MERCK & CO. INC. 2007 3 0.84%
MMR MMR / MERCK & CO. INC. 2008 5 1.4%
MMR MMR / MERCK & CO. INC. 2009 2 0.56%
MMR MMR / MERCK & CO. INC. Unknown 1 0.28%
MMR MMR / MERCK & CO. INC. TOTAL 18 5.04%
MMR MMR / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR MMR / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MMR TD / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
MMR TD / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
MMR TDAP / SANOFI PASTEUR 2008 1 0.28%
MMR TDAP / SANOFI PASTEUR 2009 1 0.28%
MMR TDAP / SANOFI PASTEUR TOTAL 2 0.56%
MMR TDAP / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR TDAP / UNKNOWN MANUFACTURER 2009 1 0.28%
MMR TDAP / UNKNOWN MANUFACTURER TOTAL 2 0.56%
MMR TTOX / UNKNOWN MANUFACTURER 2004 1 0.28%
MMR TTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR TTOX / UNKNOWN MANUFACTURER TOTAL 2 0.56%
MMR TYP / UNKNOWN MANUFACTURER 2008 1 0.28%
MMR TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MMR VARCEL / MERCK & CO. INC. 2001 1 0.28%
MMR VARCEL / MERCK & CO. INC. 2004 1 0.28%
MMR VARCEL / MERCK & CO. INC. 2008 2 0.56%
MMR VARCEL / MERCK & CO. INC. TOTAL 4 1.12%
MMR TOTAL 45 12.61%
MNQ HEPA / MERCK & CO. INC. 2007 2 0.56%
MNQ HEPA / MERCK & CO. INC. TOTAL 2 0.56%
MNQ HPV4 / MERCK & CO. INC. 2007 2 0.56%
MNQ HPV4 / MERCK & CO. INC. TOTAL 2 0.56%
MNQ MNQ / AVENTIS PASTEUR 2005 1 0.28%
MNQ MNQ / AVENTIS PASTEUR 2006 2 0.56%
MNQ MNQ / AVENTIS PASTEUR TOTAL 3 0.84%
MNQ MNQ / SANOFI PASTEUR 2007 4 1.12%
MNQ MNQ / SANOFI PASTEUR 2009 1 0.28%
MNQ MNQ / SANOFI PASTEUR TOTAL 5 1.4%
MNQ TDAP / GLAXOSMITHKLINE BIOLOGICALS 2006 1 0.28%
MNQ TDAP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
MNQ VARCEL / MERCK & CO. INC. 2007 1 0.28%
MNQ VARCEL / MERCK & CO. INC. TOTAL 1 0.28%
MNQ TOTAL 14 3.92%
PPV FLU / UNKNOWN MANUFACTURER 2005 1 0.28%
PPV FLU / UNKNOWN MANUFACTURER TOTAL 1 0.28%
PPV PPV / MERCK & CO. INC. 2005 1 0.28%
PPV PPV / MERCK & CO. INC. TOTAL 1 0.28%
PPV TOTAL 2 0.56%
RAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2003 2 0.56%
RAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2007 1 0.28%
RAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 3 0.84%
RAB JEV / SANOFI PASTEUR 2008 1 0.28%
RAB JEV / SANOFI PASTEUR TOTAL 1 0.28%
RAB RAB / CHIRON CORPORATION 2003 1 0.28%
RAB RAB / CHIRON CORPORATION 2005 1 0.28%
RAB RAB / CHIRON CORPORATION TOTAL 2 0.56%
RAB RAB / SANOFI PASTEUR 2008 1 0.28%
RAB RAB / SANOFI PASTEUR TOTAL 1 0.28%
RAB RAB / UNKNOWN MANUFACTURER 2003 1 0.28%
RAB RAB / UNKNOWN MANUFACTURER 2007 1 0.28%
RAB RAB / UNKNOWN MANUFACTURER TOTAL 2 0.56%
RAB TYP / BERNA BIOTECH, LTD 2008 1 0.28%
RAB TYP / BERNA BIOTECH, LTD TOTAL 1 0.28%
RAB TOTAL 10 2.8%
RUB RUB / MERCK & CO. INC. Unknown 1 0.28%
RUB RUB / MERCK & CO. INC. TOTAL 1 0.28%
RUB TOTAL 1 0.28%
SMALL SMALL / ACAMBIS, INC. 2008 1 0.28%
SMALL SMALL / ACAMBIS, INC. 2009 1 0.28%
SMALL SMALL / ACAMBIS, INC. TOTAL 2 0.56%
SMALL TOTAL 2 0.56%
TD HEP / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
TD HEP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
TD HEPA / GLAXOSMITHKLINE BIOLOGICALS 2005 1 0.28%
TD HEPA / GLAXOSMITHKLINE BIOLOGICALS 2006 1 0.28%
TD HEPA / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
TD HEPA / GLAXOSMITHKLINE BIOLOGICALS TOTAL 3 0.84%
TD HEPA / UNKNOWN MANUFACTURER 2003 1 0.28%
TD HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD IPV / SANOFI PASTEUR 2007 1 0.28%
TD IPV / SANOFI PASTEUR TOTAL 1 0.28%
TD IPV / UNKNOWN MANUFACTURER 2005 1 0.28%
TD IPV / UNKNOWN MANUFACTURER 2008 2 0.56%
TD IPV / UNKNOWN MANUFACTURER TOTAL 3 0.84%
TD MEN / UNKNOWN MANUFACTURER 2008 1 0.28%
TD MEN / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD MMR / UNKNOWN MANUFACTURER 2008 1 0.28%
TD MMR / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD TD / AVENTIS PASTEUR 2003 1 0.28%
TD TD / AVENTIS PASTEUR 2006 1 0.28%
TD TD / AVENTIS PASTEUR TOTAL 2 0.56%
TD TD / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
TD TD / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
TD TD / SANOFI PASTEUR 2007 1 0.28%
TD TD / SANOFI PASTEUR TOTAL 1 0.28%
TD TD / UNKNOWN MANUFACTURER 2005 1 0.28%
TD TD / UNKNOWN MANUFACTURER 2008 1 0.28%
TD TD / UNKNOWN MANUFACTURER TOTAL 2 0.56%
TD TYP / AVENTIS PASTEUR 2003 1 0.28%
TD TYP / AVENTIS PASTEUR 2006 1 0.28%
TD TYP / AVENTIS PASTEUR TOTAL 2 0.56%
TD TYP / UNKNOWN MANUFACTURER 2005 1 0.28%
TD TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD YF / SANOFI PASTEUR 2007 1 0.28%
TD YF / SANOFI PASTEUR TOTAL 1 0.28%
TD YF / UNKNOWN MANUFACTURER 2003 1 0.28%
TD YF / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD TOTAL 22 6.16%
TDAP FLU / SANOFI PASTEUR 2007 1 0.28%
TDAP FLU / SANOFI PASTEUR TOTAL 1 0.28%
TDAP FLU / UNKNOWN MANUFACTURER 2008 1 0.28%
TDAP FLU / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TDAP HEP / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
TDAP HEP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
TDAP HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
TDAP HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2009 1 0.28%
TDAP HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 2 0.56%
TDAP HPV4 / MERCK & CO. INC. 2009 1 0.28%
TDAP HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
TDAP IPV / SANOFI PASTEUR 2008 1 0.28%
TDAP IPV / SANOFI PASTEUR TOTAL 1 0.28%
TDAP MMR / MERCK & CO. INC. 2008 2 0.56%
TDAP MMR / MERCK & CO. INC. 2009 2 0.56%
TDAP MMR / MERCK & CO. INC. TOTAL 4 1.12%
TDAP MNQ / AVENTIS PASTEUR 2006 1 0.28%
TDAP MNQ / AVENTIS PASTEUR TOTAL 1 0.28%
TDAP TDAP / AVENTIS PASTEUR 2006 2 0.56%
TDAP TDAP / AVENTIS PASTEUR TOTAL 2 0.56%
TDAP TDAP / GLAXOSMITHKLINE BIOLOGICALS 2006 1 0.28%
TDAP TDAP / GLAXOSMITHKLINE BIOLOGICALS Unknown 1 0.28%
TDAP TDAP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 2 0.56%
TDAP TDAP / SANOFI PASTEUR 2007 3 0.84%
TDAP TDAP / SANOFI PASTEUR 2008 5 1.4%
TDAP TDAP / SANOFI PASTEUR 2009 2 0.56%
TDAP TDAP / SANOFI PASTEUR TOTAL 10 2.8%
TDAP TDAP / UNKNOWN MANUFACTURER 2008 1 0.28%
TDAP TDAP / UNKNOWN MANUFACTURER 2009 1 0.28%
TDAP TDAP / UNKNOWN MANUFACTURER TOTAL 2 0.56%
TDAP TYP / UNKNOWN MANUFACTURER 2008 1 0.28%
TDAP TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TDAP TOTAL 29 8.12%
TTOX DTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
TTOX DTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TTOX HEP / MERCK & CO. INC. 2008 1 0.28%
TTOX HEP / MERCK & CO. INC. TOTAL 1 0.28%
TTOX HEPA / UNKNOWN MANUFACTURER 2007 1 0.28%
TTOX HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TTOX HPV4 / MERCK & CO. INC. 2007 1 0.28%
TTOX HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
TTOX IPV / UNKNOWN MANUFACTURER 2008 1 0.28%
TTOX IPV / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TTOX MMR / MERCK & CO. INC. 2004 1 0.28%
TTOX MMR / MERCK & CO. INC. 2008 1 0.28%
TTOX MMR / MERCK & CO. INC. TOTAL 2 0.56%
TTOX TTOX / UNKNOWN MANUFACTURER 2004 1 0.28%
TTOX TTOX / UNKNOWN MANUFACTURER 2007 1 0.28%
TTOX TTOX / UNKNOWN MANUFACTURER 2008 1 0.28%
TTOX TTOX / UNKNOWN MANUFACTURER TOTAL 3 0.84%
TTOX VARCEL / MERCK & CO. INC. 2004 1 0.28%
TTOX VARCEL / MERCK & CO. INC. TOTAL 1 0.28%
TTOX TOTAL 11 3.08%
TYP DTIPV / PASTEUR MERIEUX INST. 2007 1 0.28%
TYP DTIPV / PASTEUR MERIEUX INST. TOTAL 1 0.28%
TYP DTIPV / UNKNOWN MANUFACTURER 2007 1 0.28%
TYP DTIPV / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TYP FLU / UNKNOWN MANUFACTURER 2008 1 0.28%
TYP FLU / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TYP HEPA / GLAXOSMITHKLINE BIOLOGICALS 2005 1 0.28%
TYP HEPA / GLAXOSMITHKLINE BIOLOGICALS 2006 1 0.28%
TYP HEPA / GLAXOSMITHKLINE BIOLOGICALS 2007 1 0.28%
TYP HEPA / GLAXOSMITHKLINE BIOLOGICALS TOTAL 3 0.84%
TYP HEPA / MERCK & CO. INC. 2007 1 0.28%
TYP HEPA / MERCK & CO. INC. TOTAL 1 0.28%
TYP HEPA / UNKNOWN MANUFACTURER 2001 1 0.28%
TYP HEPA / UNKNOWN MANUFACTURER 2003 2 0.56%
TYP HEPA / UNKNOWN MANUFACTURER 2004 1 0.28%
TYP HEPA / UNKNOWN MANUFACTURER TOTAL 4 1.12%
TYP HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2008 1 0.28%
TYP HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
TYP IPV / AVENTIS PASTEUR 2004 1 0.28%
TYP IPV / AVENTIS PASTEUR TOTAL 1 0.28%
TYP IPV / SANOFI PASTEUR 2008 1 0.28%
TYP IPV / SANOFI PASTEUR TOTAL 1 0.28%
TYP IPV / UNKNOWN MANUFACTURER 2005 1 0.28%
TYP IPV / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TYP JEV / SANOFI PASTEUR 2008 1 0.28%
TYP JEV / SANOFI PASTEUR TOTAL 1 0.28%
TYP MMR / MERCK & CO. INC. 2008 1 0.28%
TYP MMR / MERCK & CO. INC. TOTAL 1 0.28%
TYP RAB / SANOFI PASTEUR 2008 1 0.28%
TYP RAB / SANOFI PASTEUR TOTAL 1 0.28%
TYP TD / AVENTIS PASTEUR 2003 1 0.28%
TYP TD / AVENTIS PASTEUR 2006 1 0.28%
TYP TD / AVENTIS PASTEUR TOTAL 2 0.56%
TYP TD / UNKNOWN MANUFACTURER 2005 1 0.28%
TYP TD / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TYP TDAP / UNKNOWN MANUFACTURER 2008 1 0.28%
TYP TDAP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TYP TYP / AVENTIS PASTEUR 2003 2 0.56%
TYP TYP / AVENTIS PASTEUR 2004 1 0.28%
TYP TYP / AVENTIS PASTEUR 2006 1 0.28%
TYP TYP / AVENTIS PASTEUR TOTAL 4 1.12%
TYP TYP / BERNA BIOTECH, LTD 2008 1 0.28%
TYP TYP / BERNA BIOTECH, LTD TOTAL 1 0.28%
TYP TYP / UNKNOWN MANUFACTURER 2001 1 0.28%
TYP TYP / UNKNOWN MANUFACTURER 2005 1 0.28%
TYP TYP / UNKNOWN MANUFACTURER 2007 2 0.56%
TYP TYP / UNKNOWN MANUFACTURER 2008 1 0.28%
TYP TYP / UNKNOWN MANUFACTURER TOTAL 5 1.4%
TYP YF / AVENTIS PASTEUR 2003 1 0.28%
TYP YF / AVENTIS PASTEUR TOTAL 1 0.28%
TYP YF / UNKNOWN MANUFACTURER 2003 1 0.28%
TYP YF / UNKNOWN MANUFACTURER 2007 1 0.28%
TYP YF / UNKNOWN MANUFACTURER TOTAL 2 0.56%
TYP TOTAL 35 9.8%
UNK UNK / UNKNOWN MANUFACTURER 1996 1 0.28%
UNK UNK / UNKNOWN MANUFACTURER TOTAL 1 0.28%
UNK TOTAL 1 0.28%
VARCEL DTAP / UNKNOWN MANUFACTURER 2007 1 0.28%
VARCEL DTAP / UNKNOWN MANUFACTURER 2008 1 0.28%
VARCEL DTAP / UNKNOWN MANUFACTURER TOTAL 2 0.56%
VARCEL HEPA / MERCK & CO. INC. 2007 1 0.28%
VARCEL HEPA / MERCK & CO. INC. TOTAL 1 0.28%
VARCEL HPV4 / MERCK & CO. INC. 2007 2 0.56%
VARCEL HPV4 / MERCK & CO. INC. TOTAL 2 0.56%
VARCEL MMR / MERCK & CO. INC. 2001 1 0.28%
VARCEL MMR / MERCK & CO. INC. 2004 1 0.28%
VARCEL MMR / MERCK & CO. INC. 2008 2 0.56%
VARCEL MMR / MERCK & CO. INC. TOTAL 4 1.12%
VARCEL MNQ / SANOFI PASTEUR 2007 1 0.28%
VARCEL MNQ / SANOFI PASTEUR TOTAL 1 0.28%
VARCEL TTOX / UNKNOWN MANUFACTURER 2004 1 0.28%
VARCEL TTOX / UNKNOWN MANUFACTURER TOTAL 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 1998 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 2000 6 1.68%
VARCEL VARCEL / MERCK & CO. INC. 2001 3 0.84%
VARCEL VARCEL / MERCK & CO. INC. 2004 3 0.84%
VARCEL VARCEL / MERCK & CO. INC. 2005 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 2007 4 1.12%
VARCEL VARCEL / MERCK & CO. INC. 2008 4 1.12%
VARCEL VARCEL / MERCK & CO. INC. 2009 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. Unknown 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. TOTAL 24 6.72%
VARCEL TOTAL 35 9.8%
VARZOS VARZOS / MERCK & CO. INC. Unknown 1 0.28%
VARZOS VARZOS / MERCK & CO. INC. TOTAL 1 0.28%
VARZOS TOTAL 1 0.28%
YF DTIPV / PASTEUR MERIEUX INST. 2007 1 0.28%
YF DTIPV / PASTEUR MERIEUX INST. TOTAL 1 0.28%
YF HEPA / MERCK & CO. INC. 2007 1 0.28%
YF HEPA / MERCK & CO. INC. TOTAL 1 0.28%
YF HEPA / UNKNOWN MANUFACTURER 2003 2 0.56%
YF HEPA / UNKNOWN MANUFACTURER TOTAL 2 0.56%
YF IPV / SANOFI PASTEUR 2007 1 0.28%
YF IPV / SANOFI PASTEUR TOTAL 1 0.28%
YF MEN / AVENTIS PASTEUR 2005 1 0.28%
YF MEN / AVENTIS PASTEUR TOTAL 1 0.28%
YF TD / AVENTIS PASTEUR 2003 1 0.28%
YF TD / AVENTIS PASTEUR TOTAL 1 0.28%
YF TD / SANOFI PASTEUR 2007 1 0.28%
YF TD / SANOFI PASTEUR TOTAL 1 0.28%
YF TYP / AVENTIS PASTEUR 2003 2 0.56%
YF TYP / AVENTIS PASTEUR TOTAL 2 0.56%
YF TYP / UNKNOWN MANUFACTURER 2007 1 0.28%
YF TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
YF YF / AVENTIS PASTEUR 2003 1 0.28%
YF YF / AVENTIS PASTEUR 2005 1 0.28%
YF YF / AVENTIS PASTEUR TOTAL 2 0.56%
YF YF / SANOFI PASTEUR 2007 1 0.28%
YF YF / SANOFI PASTEUR TOTAL 1 0.28%
YF YF / UNKNOWN MANUFACTURER 2003 1 0.28%
YF YF / UNKNOWN MANUFACTURER 2007 1 0.28%
YF YF / UNKNOWN MANUFACTURER TOTAL 2 0.56%
YF TOTAL 16 4.48%
TOTAL 589 164.99%
Unknown ANTH ANTH / EMERGENT BIOSOLUTIONS Unknown 1 0.28%
ANTH ANTH / EMERGENT BIOSOLUTIONS TOTAL 1 0.28%
ANTH TOTAL 1 0.28%
FLU FLU / AVENTIS PASTEUR Unknown 1 0.28%
FLU FLU / AVENTIS PASTEUR TOTAL 1 0.28%
FLU TOTAL 1 0.28%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS 2002 1 0.28%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS 2004 1 0.28%
HEP HEP / GLAXOSMITHKLINE BIOLOGICALS TOTAL 2 0.56%
HEP HEP / UNKNOWN MANUFACTURER Unknown 1 0.28%
HEP HEP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEP TOTAL 3 0.84%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS Unknown 1 0.28%
HEPA HEPA / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
HEPA HEPA / UNKNOWN MANUFACTURER 2001 1 0.28%
HEPA HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPA TYP / UNKNOWN MANUFACTURER 2001 1 0.28%
HEPA TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPA TOTAL 3 0.84%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2003 1 0.28%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS Unknown 2 0.56%
HEPAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 3 0.84%
HEPAB RAB / UNKNOWN MANUFACTURER 2003 1 0.28%
HEPAB RAB / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPAB TD / UNKNOWN MANUFACTURER 2003 1 0.28%
HEPAB TD / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HEPAB TOTAL 5 1.4%
HPV4 HPV4 / MERCK & CO. INC. 2007 6 1.68%
HPV4 HPV4 / MERCK & CO. INC. 2008 3 0.84%
HPV4 HPV4 / MERCK & CO. INC. Unknown 16 4.48%
HPV4 HPV4 / MERCK & CO. INC. TOTAL 25 7%
HPV4 MMR / MERCK & CO. INC. Unknown 1 0.28%
HPV4 MMR / MERCK & CO. INC. TOTAL 1 0.28%
HPV4 UNK / UNKNOWN MANUFACTURER Unknown 1 0.28%
HPV4 UNK / UNKNOWN MANUFACTURER TOTAL 1 0.28%
HPV4 VARCEL / MERCK & CO. INC. 2007 1 0.28%
HPV4 VARCEL / MERCK & CO. INC. TOTAL 1 0.28%
HPV4 TOTAL 28 7.84%
MMR HPV4 / MERCK & CO. INC. Unknown 1 0.28%
MMR HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
MMR MMR / MERCK & CO. INC. 1985 1 0.28%
MMR MMR / MERCK & CO. INC. 1992 1 0.28%
MMR MMR / MERCK & CO. INC. 1994 1 0.28%
MMR MMR / MERCK & CO. INC. 1995 1 0.28%
MMR MMR / MERCK & CO. INC. 2002 1 0.28%
MMR MMR / MERCK & CO. INC. Unknown 2 0.56%
MMR MMR / MERCK & CO. INC. TOTAL 7 1.96%
MMR UNK / UNKNOWN MANUFACTURER Unknown 1 0.28%
MMR UNK / UNKNOWN MANUFACTURER TOTAL 1 0.28%
MMR TOTAL 9 2.52%
RAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2003 1 0.28%
RAB HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
RAB RAB / UNKNOWN MANUFACTURER 2003 1 0.28%
RAB RAB / UNKNOWN MANUFACTURER TOTAL 1 0.28%
RAB TD / UNKNOWN MANUFACTURER 2003 1 0.28%
RAB TD / UNKNOWN MANUFACTURER TOTAL 1 0.28%
RAB TOTAL 3 0.84%
RUB RUB / MERCK & CO. INC. Unknown 1 0.28%
RUB RUB / MERCK & CO. INC. TOTAL 1 0.28%
RUB TOTAL 1 0.28%
TD HEPAB / GLAXOSMITHKLINE BIOLOGICALS 2003 1 0.28%
TD HEPAB / GLAXOSMITHKLINE BIOLOGICALS TOTAL 1 0.28%
TD RAB / UNKNOWN MANUFACTURER 2003 1 0.28%
TD RAB / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD TD / UNKNOWN MANUFACTURER 2003 1 0.28%
TD TD / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TD TOTAL 3 0.84%
TYP HEPA / UNKNOWN MANUFACTURER 2001 1 0.28%
TYP HEPA / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TYP TYP / UNKNOWN MANUFACTURER 2001 1 0.28%
TYP TYP / UNKNOWN MANUFACTURER TOTAL 1 0.28%
TYP TOTAL 2 0.56%
UNK HPV4 / MERCK & CO. INC. Unknown 1 0.28%
UNK HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
UNK MMR / MERCK & CO. INC. Unknown 1 0.28%
UNK MMR / MERCK & CO. INC. TOTAL 1 0.28%
UNK UNK / UNKNOWN MANUFACTURER Unknown 1 0.28%
UNK UNK / UNKNOWN MANUFACTURER TOTAL 1 0.28%
UNK TOTAL 3 0.84%
VARCEL HPV4 / MERCK & CO. INC. 2007 1 0.28%
VARCEL HPV4 / MERCK & CO. INC. TOTAL 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 2001 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 2005 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 2007 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. 2008 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. Unknown 1 0.28%
VARCEL VARCEL / MERCK & CO. INC. TOTAL 5 1.4%
VARCEL TOTAL 6 1.68%
TOTAL 68 19.05%
TOTAL † 723 † 202.52%
† Because some events have multiple vaccinations and symptoms, a single event can account for multiple entries in this table. This is the reason why the Total Count is greater than 357 (the number of events found), and the Total Percentage is greater than 100.

 

New Search

 

Event Details Report
 
VAERS ID: 150725   Vaccination Date: 1998-12-08
Age: 24.0   Onset Date: 1999-03-14   Days later: 96
Gender: Male   Submitted: 2000-03-20
State: Georga   Entered: 2000-04-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: Mother (spouse of pt) had blood tests-results pending
Previous Vaccinations:
Other Medications: analgesics
Preexisting Conditions: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH MICHIGAN DEPT PUB HLTH FAV017 1 SC  
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous
Write-up: Had healthy daughter 02/01/1997. Started Anthrax series 11/20/1998. Wife has had 2 miscarriages 03/14/99 and 03/14/2000 at 12 and 8 week gestation. Father has had 4 doses of vax.
VAERS ID: 156642   Vaccination Date: 1998-07-02
Age: 26.0   Onset Date: 1998-11-05   Days later: 126
Gender: Female   Submitted: 2000-05-16
State: Michigan   Entered: 2000-07-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: ultrasound - B/L choroid plexus cysts on 11/9/98 ultrasound - fetus too small for gestational age on 1/22/99
Previous Vaccinations:
Other Medications: Zithromax, Synthroid
Preexisting Conditions: pregnancy; hypothyroidism; sinusitis
CDC 'Split Type': WAES98090380
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Cyst, Laboratory test abnormal, Sinusitis
Write-up: Subsequent to receiving one dose of varicella virus vaccine live on 7/2/98, the pt discovered she was pregnant on 7/27/98 (LMP 6/12/98). Follow-up information reported that in November of 1997, the pt had a miscarriage. Additional follow-up from a physician reported that on 11/5/98, the pt experienced sinusitis and on 11/9/98 an ultrasound revealed bilateral choroid plexus cysts which subsequently resolved. The ultrasound also showed the fetus to be small for gestational age. The pt gave birth to a healthy, normal live born male infant on 3/1/99.
VAERS ID: 160211   Vaccination Date: 2000-08-15
Age: 35.0   Onset Date: 2000-08-16   Days later: 1
Gender: Female   Submitted: 2000-09-26
State: Indiana   Entered: 2000-10-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Ortho-Novum
Preexisting Conditions: allergy to PCN and sulfa
CDC 'Split Type': WAES00091480
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.   1 SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Injection site pain
Write-up: Following vaccination, the pt found out that she was 1.5 weeks pregnant at the time of the second vaccination and her LMP was approximately 8/4/00. Subsequently on 9/16/00, she miscarried her fetus. It was reported that the pt sought unspecified medical attention. Additional information has been requested. On 8/16/00 pt had soreness of her arm at the injection site and was feverish at the injection site. Follow up on 03/28/2001: "Lot number for vaccine #1 is not provided."
VAERS ID: 160374   Vaccination Date: 2000-01-24
Age: 31.0   Onset Date: 2000-01-26   Days later: 2
Gender: Female   Submitted: 2000-08-30
State: Idaho   Entered: 2000-10-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Sudafed, Vitamins
Preexisting Conditions: NONE
CDC 'Split Type': ID00037
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP SMITHKLINE BEECHAM ENG3212C6 0 IM LA
Administered by: Private     Purchased by: Private
Symptoms: Abortion spontaneous
Write-up: 48 hours post vax, the pt had a miscarriage.
VAERS ID: 164714   Vaccination Date: 2000-09-01
Age: 25.0   Onset Date: 2000-10-01   Days later: 30
Gender: Female   Submitted: 2001-01-09
State: Maryland   Entered: 2001-01-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy (LMP-09/01/2000)
CDC 'Split Type': WAES00122066
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: It was reported that the pt's last menstrual period was 2 weeks prior to vaccination. In October 2000, the pt informed her physician that she had a miscarriage. No further information is available.
VAERS ID: 164820   Vaccination Date: 2000-03-27
Age: 39.0   Onset Date: 2000-05-01   Days later: 35
Gender: Female   Submitted: 2001-01-10
State: Maine   Entered: 2001-01-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: lab test - neg varicella antibodies
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: varicella exposure
CDC 'Split Type': WAES00040262
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC. 1004J   SC  
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Foetal disorder, Laboratory test abnormal
Write-up: Information has been received from a physician concerning a 39 year old female with past varicella exposure who on 3/22/00 tested negative for varicella antibodies. Subsequently, on 3/27/00, the pt was vaccinated with 1 dose of varicella virus vaccine live. On 4/3/00, the pt learned that she was pregnant. Approx. LMP: 2/27/00, and estimated delivery date: 12/3/00. The pt miscarried on 5/1/00, at 9 1/2 weeks gestation. Additional information has been requested.
VAERS ID: 164842   Vaccination Date: 2000-02-18
Age: 36.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2001-01-15
State: California   Entered: 2001-01-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: pregnancy test - pos
Previous Vaccinations:
Other Medications:
Preexisting Conditions: allergy to Benadryl
CDC 'Split Type': 20000084291
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP SMITHKLINE BEECHAM ENG3082A4 0 IM  
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Foetal disorder, Laboratory test abnormal
Write-up: On 2/18/00, the pt received her 1st injection with Engerix-B. On 3/6/00, she had a pregnancy test which was positive. The pt's last menstrual period was 2/6/00 and the estimated date of delivery was 11/13/00. She had been pregnant for 6 weeks on 3/15/00. The information received on 1/12/01, reported the pt had a miscarriage. No further details were provided. This report was assessed as medically serious. Additional information has been requested.
VAERS ID: 168819   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2001-04-11
State: Virginia   Entered: 2001-04-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Beta-human chorionic- (+) 4-8 weeks pregnant
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy-LMP-UNK
CDC 'Split Type': WAES01040513
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC. 0106K   SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Foetal disorder, Laboratory test abnormal
Write-up: It was reported that prior to vaccination, the pt was asked by the health care provider if she was pregnant or planned to get pregnant and the woman said no. The pt's husband later told the health care provider that the woman was pregnant, but hadn't wanted to say so in front of the other children. A pregnancy test was done which confirmed she was 4-8 weeks pregnant. The woman made an appointment with her ob/gyn for two weeks later. When the woman arrived at the doctors office, she was spotting and she miscarried. A D&C was done. No further information was available.
VAERS ID: 173551   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2001-07-17
State: Florida   Entered: 2001-07-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy (LMP-UNK)
Diagnostic Lab Data: Beta-human chorionic-neg at the time of vaccination
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Concurrent conditions: pregnancy (LMP =UNK)
CDC 'Split Type': WAES01070470
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: Information has been received from a health professional concerning a female who was vaccinated with varicella virus vaccine live. At the time of vaccination, lab evaluation had revealed a negative pregnancy test. Approx. 2 weeks, post vax, the pt told the physician she was pregnant. Approx. 4-6 weeks later, the pt had a miscarriage. Medical attention was sought. No further information is available.
VAERS ID: 175491   Vaccination Date: 2000-07-07
Age: 39.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2001-11-06
State: Unknown   Entered: 2001-09-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Urine beta-human on 8/4/00-HCG (+)
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: Pregnancy (LMP-7/4/00)
CDC 'Split Type': WAES00080529
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal
Write-up: Information has been received from an NP concerning a 39 year old female who on 7/7/00, was vaccinated with 1 dose of varicella virus vaccine live (site unknown). On 8/4/00, during a routine check-up, the pt's urine was HCG positive. LMP: 7/4/00. The pt used the rhythm birth control method. The pt had not yet seen her gynecologist. Follow-up information from the nurse practitioner noted that the pt had a miscarriage and was currently well and was trying to conceive again. No further information is available. F/U states: The date of 2000 was added to field 11 to reflect the adverse event onset date of the miscarriage.

 

 

 

  

 

VAERS ID: 177956   Vaccination Date: 2000-12-14
Age: 31.0   Onset Date: 2001-03-13   Days later: 89
Gender: Female   Submitted: 2001-11-15
State: Unknown   Entered: 2001-11-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Ultrasound to rule out a missed abortion and no fetal heart beat was detected
Previous Vaccinations:
Other Medications: Prenatal vitamins
Preexisting Conditions:
CDC 'Split Type': WAES01020266
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.   1 SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: Pt believes she became pregnant on 1/19/01 after receiving varicella virus vaccine on 12/14/00. Pt's last menstrual period was on 1/5/01. The pt planned to see her health care provider on 2/2/01. The OB/GYN reported the pt had no previous pregnancies. No fetal heart beat was detected on two ultrasounds. The pt had a spontaneous abortion on 3/13/01, 9 5/7 weeks from her last menstrual period. The products of conception were examined. It was not known if the fetus was normal. No further info is available.
VAERS ID: 178596   Vaccination Date: 2000-10-21
Age: 31.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2001-11-28
State: Unknown   Entered: 2001-12-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Serum beta-human 11/7/00 (+); Urine beta-human 10/20/00 (-)
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Varicella exposure
CDC 'Split Type': WAES00110752
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal
Write-up: Information has been received from a medical assistant and a physician concerning a 31 year old female with no known drug allergies and a recent chicken pox exposure who, on 10/21/00, was vaccinated with varicella virus vaccine live. There was no concomitant medication. It was noted that the pt was vaccinated because she had been exposed to chicken pox. A urine pregnancy test was obtained before vaccination which was negative and her last menstrual period was 10/4/00. On 11/7/00, a serum pregnancy test was done and showed positive results. It was noted that there was no report of rash at this time. Follow-up information from the medical assistant, indicated that the pt had a spontaneous abortion early in her pregnancy.
VAERS ID: 179606   Vaccination Date: 2001-09-18
Age: 29.0   Onset Date: 2001-11-23   Days later: 66
Gender: Female   Submitted: 2001-12-26
State: Unknown   Entered: 2002-01-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy (LMP-8/4/01)
Diagnostic Lab Data: Ultrasound 10/15/01-Pregnancy confirmed; Ultrasound 10/31/01-Viable 8 week pregnancy
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions:
CDC 'Split Type': WAES01100288
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.   0 SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal
Write-up: Information has been received from an NP concerning a 29 year old female pt who on an unspecified date was vaccinated with varicella virus vaccine live. The NP indicated that the pt was 2 weeks pregnant when she received the vaccination. No adverse experiences were reported. The pt sought unspecified medical attention. Follow-up information was received from a physician's assistant who indicated that the pt (gravida 4, para 3) was vaccinated on 9/18/01 with a 1st dose of varicella virus vaccine live for immigration purposes. The pt has a miscarriage on 11/23/01 (12 weeks from LMP). There were no birth defects. No further information is available.
VAERS ID: 180301   Vaccination Date: 2001-02-05
Age: 33.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2002-01-14
State: Unknown   Entered: 2002-01-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Beta-human chorionic-positive
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy (LMP-UNK)
CDC 'Split Type': WAES01041197
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.   0 SC  
Administered by:      Purchased by:
Symptoms: Abortion spontaneous, Laboratory test abnormal
Write-up: Information has been received from a RN concerning a 33 year old female who was vaccinated with a first and second dose of varicella virus vaccine live on 05-FEB-2001 and 28-MAR-2001, respectively. The pt informed the RN that she tested positive for pregnancy with a home pregnancy test. Unspecified medical attention was sought. In follow up the RN reported that the pt had an uncomplicated first trimester spontaneous abortion. The RN reported that neither the physician nor the pt thought that there was any relationship between the exposure and the miscarriage. No further information is available.
VAERS ID: 180624   Vaccination Date: 2001-05-27
Age: 23.0   Onset Date: 2001-09-10   Days later: 106
Gender: Female   Submitted: 2002-01-23
State: Unknown   Entered: 2002-01-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Pregnancy (LMP-UNK)
CDC 'Split Type': WAES01090401
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.     SC  
VARCEL MERCK & CO. INC.     SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Back pain, Chromosome abnormality
Write-up: Information has been received from a husband and his 23 year old wife who on 6/27/01, the wife was vaccinated with varicella virus vaccine live and MMR. The pt stated that after she had the vaccinations, she found out that she had become pregnant on 6/17/01. Subsequently, on 9/10/01, the pt had a "natural miscarriage". Her physician told her that the miscarriage was not because of the vaccines, but because of "some chromosome problem". The pt further stated that after the miscarriage, her health was good although she was "still suffering from back pain but reducing day by day". Back pain was considered to be an incidental finding. Additional information is not expected.
VAERS ID: 180625   Vaccination Date: 2001-04-13
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2002-01-23
State: Unknown   Entered: 2002-01-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Beta-human chorionic home test-neg; Beta-human chorionic-confirmed pregnancy 4/20/01
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy (LMP-UNKNOWN)
CDC 'Split Type': WAES01042485
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC  
Administered by:      Purchased by:
Symptoms: Abortion spontaneous, Laboratory test abnormal
Write-up: Information has been received from a physician concerning a mother of a pediatric pt who on 4/13/01 was vaccinated with varicella virus vaccine live. The physician reported that the female reported that she performed a home pregnancy test that was negative. A week later, she had a lab test that confirmed pregnancy. The physician reported that because the woman was not the doctor's pt, there was no additional information related to last menstrual period (LMP) or date of delivery. The physician "feels the woman is about 6 weeks pregnant". The physician did not have the name of the obstetrician/gynecologist. In follow-up, the physician reported that she was informed that the pt had an early miscarriage of this pregnancy. Additional information has been requested.
VAERS ID: 181022   Vaccination Date: 2000-11-28
Age: 41.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2002-02-05
State: New Jersey   Entered: 2002-02-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: UNK
CDC 'Split Type': 5538604
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU WYETH PHARMACEUTICALS, INC   0 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: A 41 year old female reported that she received Flu Shield ('00-'01) on 11/28/00. On that day, she reported being approx. 2 weeks pregnant. Follow-up information has been received on 2/1/02 from the now 42 year old female who reported that she "had a miscarriage". The date of the event was not reported. The event was considered to be an "Other Important Medical Event".
VAERS ID: 184565   Vaccination Date: 2002-04-17
Age: 15.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2002-05-13
State: Unknown   Entered: 2002-05-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy NOS (LMP-1/28/02)
CDC 'Split Type': WAES0204USA02990
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC. 0698L 0 SC  
VARCEL MERCK & CO. INC.     SC  
Administered by: Unknown     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: Information has been received from an NP concerning a 15 year old pregnant female who in early 4/02, was vaccinated with varicella virus vaccine live and concomitant suspect therapy MMRII. The NP reported that approx. 1 week after the vaccinations, the pt had a miscarriage. The NP also reported that the pt estimated the date of her last menstrual period to be 1/28/02. Additional information has been requested. Conflicting info has been received from a public health nurse. The nurse reported that the pt did not receive the varicella virus vaccine live, but, on 4/17/02, the pt did receive the first dose of MMR II (639518/0698L). The public health nurse also reported that the pt did receive the varicella virus vaccine live, the public health nurse did not give it and she had no further info. No further info is expected.
VAERS ID: 191208   Vaccination Date: 2002-03-25
Age: 37.0   Onset Date: 2002-08-08   Days later: 136
Gender: Female   Submitted: 2002-09-19
State: California   Entered: 2002-10-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Penicilin allergy
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC. 1479L 0    
Administered by: Public     Purchased by: Private
Symptoms: Abortion spontaneous
Write-up: Conception following the advised three months waiting period for MMR vaccination resulted in miscarriage between wks 6-8.
VAERS ID: 195285   Vaccination Date: 2002-11-06
Age: 24.0   Onset Date: 2002-11-16   Days later: 10
Gender: Female   Submitted: 2002-12-20
State: Maine   Entered: 2002-12-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: Beta human chorionic gonadotropin 40; Ultrasound - without fetal pole.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: The subject was allergic to Zyban
CDC 'Split Type': A0385861A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS 5291A4 1 IM LA
Administered by: Private     Purchased by: Public
Symptoms: Abortion spontaneous, Blood gonadotrophin increased
Write-up: This report was received from a nurse and prospectively described a 24 year old female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis during the first trimester of pregnancy. The subject's medical history included allergy to Zyban. Concurrent medications were unknown. She experienced no adverse events following previous immunizations. On 11/6/02, the subject received her second injection of Engerix B (lot 5291A4). Unknown to the vaccine administor, the subject was pregnant at the time. Her last menstrual period was on 9/26/02. Additonal info was received on 12/10/02. On 11/16/02, the subject experienced a miscarriage at a gestatonal age of 5 weeks. The beta human chorionic gonadotrpin concentration was "never above 40 (units and reference range unspecified)." An ultrasound performed on 11/12/02 was "without fetal pole." The reporting nurse stated that the miscarriage was "probably not related" to Engerix B adminsistration because "cramping started before injection." Miscarriage is considered medically serious (OMIC). Therefore, this report has been reclassified as serious.

 

VAERS ID: 197953   Vaccination Date: 2002-12-06
Age: 28.0   Onset Date: 2002-12-10   Days later: 4
Gender: Female   Submitted: 2003-02-11
State: North Carolina   Entered: 2003-02-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: HCG screenings
Previous Vaccinations: severe bruising;Anthrax, adsorbed (Biothrax);3;24;In Patient
Other Medications: NONE
Preexisting Conditions: NONE
CDC 'Split Type': NONE
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH EMERGENT BIOSOLUTIONS   3    
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous
Write-up: Miscarriage
VAERS ID: 204061   Vaccination Date: 2002-08-28
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2003-05-30
State: Unknown   Entered: 2003-06-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy
CDC 'Split Type': WAES0305USA02645
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: Information has been received from a registered nurse concerning a female pt who on 8/28/02 was vaccinated with a dose of MMR II, "at which time the pt stated she was not pregnant." It was noted that the "pt called and reported that she was pregnant when she received the immunization." On 11/14/02, "one of the nurses called the pt and the pt reported she had a miscarriage." The cause of death was miscarriage. The nurse also reported on another pt who received varicella vaccine live during pregnancy (WAES0205USA02764). Additional info has been requested.
VAERS ID: 204849   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2003-06-10
State: Unknown   Entered: 2003-06-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy NOS
CDC 'Split Type': WAES0306USA00317
Vaccination
Manufacturer
Lot
Dose
Route
Site
RUB MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: It was reported in a published article that a female patient in 1984 was vaccinated with a post partum dose of rubella virus vaccine live (second generation). Subsequently she had three miscarriages before delivering a boy in September 1987. The author noted that vaccinaton of women around conception may lead to stillbirths, premature delivery, and vanishing twins. It cal also be frequently associated with an early onset of autism. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. It was reported in a published article that this patient delivered her first child, a female in 1984, and received rubella virus vaccine live post partum because she had remained rubella susceptible. After three miscarriages the patient delivered a male in September 1987 and received another post-partum dose of rubella virus vaccine live because she had no detectable rubella immunity. While breast feeding he third child, a female, the patient received her third rubella virus vaccine live booster in four years as she was still rubella susceptible. According to the reporter the patient's son has autism and the patient's daughter has severe dyslexia, serious learning disabilities and ADHD. It was unknown if medical attention was sought.
VAERS ID: 204850   Vaccination Date: 0000-00-00
Age: 41.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2003-06-10
State: Unknown   Entered: 2003-06-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy NOS
CDC 'Split Type': WAES0306USA00324
Vaccination
Manufacturer
Lot
Dose
Route
Site
RUB MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: It was reported in a published article, that a 41 year old female pt, with a strong family history of immune disorders, delivered a normal girl in 1987, was vaccinated with a booster dose of rubella virus vaccine live II in the postpartum period. Subsequently her next pregnancy ended in a miscarriage. The author noted that "vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins." Adverse outcomes associated with postpartum rubella or MMR vaccine. It was unknown if medical attention was sought. It was reported in a published article, title as stated above, that a 41 year old female patient, with a strong family history of immune disorders, delivered a normal girl in 1987, was vaccinated with a booser dose of rubella virus vaccine live (second generation) in the postpartum perious. Subsequently her next pregnancy ended in a miscarriage. The auther noted that "vaccination of women around conception may lead to sillbirths, premature delivery and "vanishing twins." According to the reporter one of the patient's sons had autism (WAES#0305USA00325) and another son had speech difficulties (WAES #0404USA000703). It was unknown if medical attention was sought.
VAERS ID: 204859   Vaccination Date: 1995-11-11
Age:    Onset Date: 1995-11-11   Days later: 0
Gender: Female   Submitted: 2003-06-10
State: Unknown   Entered: 2003-06-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Miscarriage; pregnancy NOS; HIV test positive
CDC 'Split Type': WAES0306USA00327
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug administration error
Write-up: It was reported in a published article that a female patient, who is HIV positive and who had a miscarriage in 1993, who on 11/11/95 was vaccinated with a dose of MMR (second generation) while nearly three months pregnant. It was reported that the patient was placed on a protocol which mandated MMR (second generation) every 2-3 years. It was noted that the patient had a miscarriage in 1998. The author noted that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. It was unknown if medical attention was sought.
VAERS ID: 204866   Vaccination Date: 1992-01-27
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2003-06-10
State: Unknown   Entered: 2003-06-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy
CDC 'Split Type': WAES0306USA00354
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: It was reported in a published article that a female patient was vaccinated on 1/27/92, 2 days after giving birth to a normal baby girl on 1/25/92, with a dose of MMR (second generation). It was noted that the patient was vaccinated in case (she had) more children. Subsequently, the patient became pregnant again. In 1996 the patient had a miscarriage. In conclusion, the author stated that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. No further information is available.
VAERS ID: 205355   Vaccination Date: 1989-02-06
Age: 21.0   Onset Date: 2002-02-06   Days later: 4748
Gender: Female   Submitted: 2003-06-24
State: North Carolina   Entered: 2003-06-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Current Illness: None
Diagnostic Lab Data: All hereditary conditions were negative. High antiphospholipid and anti cardiolipin antibodies are positive. Patient plans to be checked for other maternal antibodies which may be affecting ability to stay pregnant and have a healthy preg
Previous Vaccinations: In daughter, reaction to IPV shot; prolonged scream crying and loss of eye contact and cessation of verbal coos for 3 weeks; pos
Other Medications: None
Preexisting Conditions: None prior to HELLP syndrome pregnancy; pre-conception counseling for baby #2 produced labwork indicating antiphospholipid antibodies.
CDC 'Split Type': None prior to HELLP syndrome pregnancy; pre-conception counseling for baby #2 produced labwork indicating antiphospholipid antibodies.
Vaccination
Manufacturer
Lot
Dose
Route
Site
MER MERCK & CO. INC. Unknown 1 IM LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Dyspepsia, Tongue disorder, Vomiting
Write-up: Day of: No noticeable adverse events recalled. Possible long term adverse effects: development of acquired condition of antiphospholipid antibodies due to fetal phospholipids possibly contained in the RA27/3 rubella vaccine that was administered. The antiphospholipid antibodies have caused symptoms in patient during pregnancy only. Symptoms have included: recurring miscarriages, clots in placenta during pregnancy which resulted in near fatal HELLP syndrome condition in pregnancy. HELLP went unnoticed because patient did not have high BP and did not have protein in urine even on day of emergency c-section. Patient possibly developed auto-antibodies to other fetal proteins contained in RA27/3 vaccine which produced additional symptoms during pregnancy as follows: 8-10 vomit sessions per day in 1st trimester of HELLP pregnancy; 5-6 vomit sessions per day in 2nd trimester; 1-2 vomit sessions per day up to 34 weeks; throughout entire pregnancy, every day there was extreme flu-like symptoms with inability to eat, drink, keep any food down, work or perform normal functions; foaming at mouth during all waking hours began at 12 weeks and continued to 22 weeks, the consistency of the mouth foam was that of egg whites whipped to medium peaks, white spots covered inside of mouth and tongue, extreme indigestion despite minimal food intake. Patient is extremely healthy, physically active and a productive working citizen in a non-pregnant state. At least 1 miscarriage post HELLP pregnancy and 2-3 prior. No, patient has long-term and permanent immune-mediated reproductive problems, as evidenced by amnastic immune effect whereby pregnancy 1 produced near death HELLP Syndrome and emergency C-section at 34 wks, pregnancy 2 miscarried at 8.5 weeks and pregnancy 3 miscarried at 6 weeks. One early miscarriage occurred before HELLP pregnancy. Patient believes her CD4 memory T-cells are reacting to a pregnancy specific/ fetal-specific/ placental or amniotic specific peptide as a result of this vaccine which used multiple products
VAERS ID: 207586   Vaccination Date: 2003-07-16
Age: 26.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2003-08-05
State: Virginia   Entered: 2003-08-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH EMERGENT BIOSOLUTIONS        
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
Write-up: LMP 6/25/03. Anthrax vaccine 7/16/03. Miscarriage 8/4/03.
VAERS ID: 213330   Vaccination Date: 1996-01-01
Age: 40.0   Onset Date: 1998-01-01   Days later: 731
Gender: Female   Submitted: 2003-11-22
State: Kansas   Entered: 2003-12-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: NONE
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK UNKNOWN MANUFACTURER        
Administered by: Private     Purchased by: Private
Symptoms: Abortion spontaneous
Write-up: 7 years ago I received the 1st vaccine in 1996. I became pregnant then received the 2nd vaccine 2 weeks into my pregnancy. My pregnancy was fine, but between the years of 1998 and 2000 I miscarried 3 times one after the other. Before receiving the vaccine I was able to carry 3 healthy pregnancies to term.
VAERS ID: 214410   Vaccination Date: 2003-10-07
Age: 30.0   Onset Date: 2003-11-10   Days later: 34
Gender: Female   Submitted: 0000-00-00
State: Unknown   Entered: 2003-12-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions:
CDC 'Split Type': PJP200300904
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU AVENTIS PASTEUR     IM  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug administration error
Write-up: A report was received from a health care professional on 10/27/03, concerning a 30 year old female vaccinee who was thought to have been pregnant at the time of receiving the Fluvirin vaccine on 10/7/03. On 10/7/03, the vaccinee received Fluvirin but is now thought to have been pregnant, this has yet to be confirmed. There was insufficient info to determine the reporter's causality. Follow up info received from a health care professional indicated that the vaccinee miscarried on 11/10/03. She had a positive pregnantcy test on 10/29/03. Follow-up pending. Upon review of this report was found to be medically significant (OMIC).

 

VAERS ID: 219778   Vaccination Date: 2004-01-28
Age: 37.0   Onset Date: 2004-04-15   Days later: 78
Gender: Female   Submitted: 2004-04-23
State: Indiana   Entered: 2004-04-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: HCG labs done on 4/16/04 and 4/18/04
Previous Vaccinations:
Other Medications:
Preexisting Conditions: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN MEDIMMUNE, INC./WYETH LABORATORIES, INC 500089P 0 IN  
Administered by: Public     Purchased by: Other
Symptoms: Abortion spontaneous, Antepartum haemorrhage, Metrorrhagia
Write-up: Became pregnant approx 2nd week of Feb 2004, About 2 weeks after receiving LAIV. On 04/16/04 in the afternoon began spotting. 04/15/04 HCG blood draw done. 04/18/04 HCG blood draw done. Count dropped by 1/2. Emergency D&C done on 04/20/04 for hemmoraging. To return for next Or. visit during week of 04/26/04. This was 5th pregnancy. Has no previous history of miscarriages.
VAERS ID: 222584   Vaccination Date: 2004-04-08
Age: 27.0   Onset Date: 2004-05-01   Days later: 23
Gender: Female   Submitted: 2004-06-10
State: Illinois   Entered: 2004-06-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Not ill, but pregnant.
Diagnostic Lab Data: none
Previous Vaccinations:
Other Medications: none
Preexisting Conditions: none
CDC 'Split Type': IL04007
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP MERCK & CO. INC. 0628N 2 IM RA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Pt. called and wanted to file a VAERS report. Pt. stated that one month after vx, she had a miscarriage. Pt. denies knowledge of pregnancy at time of vx.
VAERS ID: 225289   Vaccination Date: 2004-07-19
Age: 26.0   Onset Date: 2004-07-19   Days later: 0
Gender: Female   Submitted: 2004-08-06
State: Louisiana   Entered: 2004-08-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: Pregnancy
CDC 'Split Type': WAES0407USA02442
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy
Write-up: Information has been received from a 26 year old female, through a pregnancy registry, with no medical history or drug allergies who on 7/19/04 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The patient reported that on 7/26/04, she found out she was pregnant and miscarried on that same day. The patient believed she was only a few weeks pregnant at the time of vaccination. Unspecified medical attention was sought, but no treatment was required. Additional information has been requested.
VAERS ID: 228354   Vaccination Date: 2004-10-07
Age: 33.0   Onset Date: 2004-10-07   Days later: 0
Gender: Female   Submitted: 2004-11-05
State: Pennsylvania   Entered: 2004-10-28
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: beta human chorionic 10/12/04-pregnant
Previous Vaccinations:
Other Medications: Prenate
Preexisting Conditions: Miscarriage; Live birth; Pregnancy; Drug hypersensitivity.
CDC 'Split Type': WAES0410USA01860
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy
Write-up: Information has been received through a pregnancy registry from a 32 year old female with a sulfa allergy with a history of 2 pregnancies; one birth and one miscarriage who on 10/7/04 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included ascorbic acid (+) beta carotene (+) calcium carbonate (+) carbonyl iron (+) cholecalciferol (+) copper (unspecified) (+) docusate sodium (+) folic acid (+) magnesium oxide (+) vitamin B complex (+) vitamin E acetate (+) zinc oxide. On 10/12/04 the patient discovered she was pregnant. A pregnancy test was done. Unspecified medical attention was sought. On 10/15/04 the patient had a miscarriage. Follow up information from the RN indicated that the pt had a complete spontaneous abortion on 20Oct04, 6 weeks from her LMP. No further information is expected. Follow up 03/03/05: Patient has not recovered from the adverse event(s).
VAERS ID: 228474   Vaccination Date: 1999-06-21
Age: 37.0   Onset Date: 1999-09-15   Days later: 86
Gender: Female   Submitted: 2004-10-31
State: Unknown   Entered: 2004-10-31
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: None
Diagnostic Lab Data: N/A
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH MICHIGAN DEPT PUB HLTH FAV038 2 SC UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Urticaria
Write-up: Urticaria several weeks following administration of last of three doses of anthrax; urticaria continues and is kept under control by Zyrtec; miscarriage may have been caused by vaccine.
VAERS ID: 231630   Vaccination Date: 2004-10-28
Age: 31.0   Onset Date: 2004-11-02   Days later: 5
Gender: Female   Submitted: 2004-12-20
State: Minnesota   Entered: 2004-12-28
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Current Illness: Pregnancy
Diagnostic Lab Data: U/S confirmed fetal demise.
Previous Vaccinations:
Other Medications: Prenatal vitamins.
Preexisting Conditions: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU AVENTIS PASTEUR U1453FA 1 IM LA
Administered by: Private     Purchased by: Private
Symptoms: Abortion spontaneous
Write-up: Miscarriage at six weeks gestation one week after flu vaccination.
VAERS ID: 233259   Vaccination Date: 2004-11-05
Age: 24.0   Onset Date: 2005-01-03   Days later: 59
Gender: Female   Submitted: 2005-02-01
State: Wisconsin   Entered: 2005-02-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: 1/3/05: Ultrasound revealed no body parts.
Previous Vaccinations:
Other Medications: Tuberculin PPD
Preexisting Conditions: The patient had no known drug allergies. The patient's concurrent conditions and concurrent medications were not reported.
CDC 'Split Type': A0541795A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS 5595B6 1   LA
Administered by: Public     Purchased by: Private
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy, Vaginal haemorrhage
Write-up: This case was reported by a nurse and retrospectively described the occurrence of miscarriage in a 24 year old female pt who received hepatitis B vaccine recombinant (Engerix-B). The pt had no known drug allergies. On 05 October 2004, the pt received the first dose of Engerix-B (lot ENG5595B6). On 05 October 2004, the pt also received the second application of tuberculin purified protein derivative (unknown manufacturer). On 05 November 2004, the pt received the second dose of Engerix-B (lot ENG5595B6). Approximately 59 days after the second dose of Engerix-B, on 03 January 2005, the pt experienced "some bleeding" and was seen at a physician's office. The nurse reported that on 03 Januray 2005, "an ultrasound was done and revealed no body parts." The pt was diagnosed with a miscarriage. The nurse stated that, "it was estimated that the pt was 11 weeks [of gestation] on 03 January 2005 and had an estimated conception date between 26 October 2004 and 09 November 2004." The nurse stated that the second dose of Engerix-B was "potentially" administered during the first trimester of pregnancy. Comment: Miscarriage and vaginal bleeding were assessed as medically serious by the manufacturer (OMIC).
VAERS ID: 235261   Vaccination Date: 2005-01-28
Age: 25.0   Onset Date: 2005-02-21   Days later: 24
Gender: Female   Submitted: 2005-03-11
State: Massachusetts   Entered: 2005-03-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS AHBVA77AB 2 IM LA
MMR MERCK & CO. INC. 1033N 1 SC RA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Patient did not know she was pregnant when she received her second MMR. She miscarried at 7.5 weeks.
VAERS ID: 235584   Vaccination Date: 2004-12-10
Age: 37.0   Onset Date: 2005-01-25   Days later: 46
Gender: Female   Submitted: 2005-03-31
State: Virginia   Entered: 2005-03-31
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: PATIENT DENIES
Diagnostic Lab Data: HCG (QUANT) 28 JAN 2005 = 8869 & 29 JAN 2005 = 6254. CONSISTANT WITH PREGNANCY OF 4-6 WEEKS.
Previous Vaccinations: ;POSS MISCARRIAGE;Japanese Enceph. (J-Vax);1;0;In Patient;POSS MISCARRIAGE;Japanese Enceph. (J-Vax);2;0;In Sibling
Other Medications:
Preexisting Conditions: NONE KNOWN
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV AVENTIS PASTEUR   1 SC  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy, Vaginal haemorrhage
Write-up: PT WAS GIVEN TWO SHOTS OF JAPANESE ENCEPHALITIS VACCINE (10 & 17 DEC 2004) PRIOR TO KNOWING SHE WAS PREGNANT. UPON DETECTION OF PREGNANCY, PT DID NOT COMPLETE RECOMMENDED THREE DOSE SERIES OF JEV VACCINATION. ON 25 JAN 2005, PT PRESENTED TO CIVILIAN ER WITH OB RELATED BLEEDING. QUANT HCG SHOWED EVIDENCE OF A PREGNANCY AT 4 TO 6 WEEKS. ULTRASOUND SUGGESTED A BLIGHTED OVUM. D&C EFFECTED WITHOUT COMPLICATIONS. ADVANCED MATERNAL AGE NOTED. ASSOCIATION BETWEEN JEV VACCINATION AND MISCARRIAGE UNCLEAR BUT PT DESIRES SUBMISSION OF VAERS.
VAERS ID: 236682   Vaccination Date: 1983-12-01
Age: 1.2   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2005-04-22
State: Virginia   Entered: 2005-04-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: NONE
CDC 'Split Type': WAES0504USA01993
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug ineffective, Pneumonia, Pyrexia, Rash
Write-up: Information has been received from a consumer (also reported as mother of patient and office manager), and a physician, concerning the consumer's daughter, who at the age of 15 months, in approximately December 1983, was vaccinated with a dose of MMR (the physician could not provide lot #). Subsequently, the patient developed fever of 104F, total body rash, and pneumonia after vaccination. The mother reported that her daughter was taken to the emergency room and was treated with acetaminophen. The physician confirmed that the patient's experience was neither life threatening nor disabling and that the patient was not hospitalized following vaccination with MMR. It was also noted that as an adult, she became pregnant and miscarried. A rubella titer was then done and came back low. There was no product quality complaint involved. Upon internal review, the patient's miscarriage was considered to be an important medical event (OMIC). Additional information has been requested.

 

VAERS ID: 236819   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2005-03-27
State: Unknown   Entered: 2005-05-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': FEDREG2004
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH EMERGENT BIOSOLUTIONS   5    
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous, Arthralgia, Fatigue, Immune system disorder, Injection site erythema, Injection site swelling, Malaise, Myalgia, Urticaria
Write-up: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am extremely concerned about the anthrax vaccine. I am not a vaccine expert, but after having received five anthrax shots myself, and doing extensive reading and research, I feel there is a big problem with the vaccine. If nothing else, there are many questions that need answers. My story should be a familiar one. I was in excellent health and had no family history of autoimmune disorders. While in the military as an enlisted member, I received five anthrax shots. Three cam from lots later identified by the FDA to contain squalene. This is not the adjuvant of the original, licensed vaccine. I had severe site swelling, and by the third shot, the red, hot welt covered 70% of my arm. I had severe fatigue, malaise, joint pain and muscle soreness. I had a miscarriage after the third shot. I have since had to leave the military. Part of the reason is that I would rather quit than be subjected to another anthrax shot. The other part of the reason is that I am now physically disabled (40% so far) with an undiagnosed autoimmune disorder. My blood has been tested and I am positive for anti-squalene antibodies as well. The original vaccine from the 1970's has never proven to be effective. Studies are vague and ambiguous at best. The original product insert states that adverse reaction rate to be 0.2% with minimal side effects. This is well within acceptable industry standards. However, the product insert was changed in 2002 and the adverse reaction rate was raised to 5-35%. This is very high and begs the question, "Why did the rate change so drastically if the vaccine has not been changed?" The updated product insert also lists many autoimmune as side effects and includes fatalities. Why would anyone risk a 35% chance of coming down with an incurable autoimmune disorder or dying from taking a vaccine that has never been proven to be completely effective against all strains and all delivery methods. F
VAERS ID: 237439   Vaccination Date: 2004-03-24
Age: 22.0   Onset Date: 2004-04-11   Days later: 18
Gender: Female   Submitted: 2005-05-12
State: Wyoming   Entered: 2005-05-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Pregnancy NOS ( LMP= 04/11/2004)
CDC 'Split Type': WAES0406USA0319
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.        
TTOX UNKNOWN MANUFACTURER        
VARCEL MERCK & CO. INC.        
Administered by: Other     Purchased by: Public
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Information has been received from a physician through the manf pregnancy registry concerning a 21 year old healthy female pt who on 24Mar04 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on 24Mar04 included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a dose of tetanus toxoid. The reporter stated the pt was vaccinated on 24Mar04 in another country and her LMP was 11Apr2004. The reporter noted the pregnancy was unremarkable so far. Unspecified medical attention was sought but treatment was not required. A product quality complaint was not involved. Follow up information was received from a woman in a physician's office who reported that she had checked with the physician, who confirmed that the female pt had a miscarriage at 14 weeks gestation, on approx 19Jul04. There was no other information provided regarding the pt's adverse experience. Additional information has been requested.
VAERS ID: 248325   Vaccination Date: 2005-05-04
Age: 13.0   Onset Date: 2005-10-13   Days later: 162
Gender: Female   Submitted: 2005-11-18
State: California   Entered: 2005-11-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Prozac
Preexisting Conditions: The patient has a history of depression, attention deficit hyperactivity disorder, possible eating disorder and "family issues". Maternal drug exposure included Prozac.
CDC 'Split Type': 200502377
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER 0889P 0 IM RA
MNQ AVENTIS PASTEUR U1525AB 0 IM LA
TD AVENTIS PASTEUR U1354AA 5 IM LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abortion spontaneous, Unintended pregnancy
Write-up: Initial report received on Nov 3 2005 from an investigator participating in the above mentioned trial. A 13 year old female subject received an injection of Menactra on May 4 2005. A pregnancy is being reported. At this time, no additional information is provided. Additional information received on Nov 10 2005 from an investigator participating in the above mentioned trial. A 13 year old female subject received an intramuscular left deltoid injection of Menactra, lot number U1525AB, on May 4 2005. the subject also received, on May 4 2005 an intramuscular left deltoid injection of TD ADS adult, lot number U1354AA, and intramuscular right deltoid injection of hepatitis A vaccine, manufacturer unknown, lot number 0889P. On Oct 13 2005, the subject presented to an ER with abdominal pain and a prolapsed umbilical cord. The subject was unaware that she was pregnant. The subject delivered a 23 week gestation male fetus vaginally weighing 1440 grams. Fetal death was due to marked posterior urethral valve obstruction and dilated bladder, Ureters and kidneys. Had markedly dilated abdominal distension as shown by photos of fetus. Hypoplastic lungs also were reported. Normal male karyotype. Per the reporter, vaccination were received 25 weeks prior and probably prior to last menstrual period. The estimated date of conception was May 19 2005. The surgical pathology report indicated singleton placenta, 250gm, above the 90th percentile for gestation (three times the average length for 23 weeks), three vessel cord, exceedingly long 105cm with amnion nodosum, membranes with scant amnion nodosum, villus tissue with patchy stromal edema. The placenta showed evidence of prolonged oligohydramnios in the form of amnion nodosum. The subject was given depo Provera upon discharge from the hospital. The subject has a medical history of depression, ADHD, a possible eating disorder and family issues. Maternal drug exposure included Prozac. The fetal case is case 200502409. According to the investigator, the event of fetal demise was not rel
VAERS ID: 249177   Vaccination Date: 2005-08-24
Age: 43.0   Onset Date: 2005-08-24   Days later: 0
Gender: Female   Submitted: 2005-12-09
State: Unknown   Entered: 2005-12-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Ultrasound on Sept 27 2005 single intrauterine pregnancy. Crown rump length of 4mm. 6 week gestational age. Minimal chorioamniotic separation. Beta human chorionic 09/02/2005 positive, pregnancy confirmed.
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions:
CDC 'Split Type': WAES0509USA00415
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC. 1070P   SC  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Information has been received from a health professional concerning a 42 year old female with a history of four previous normal pregnancies and live births who on Aug 24 2005 ( 4 weeks after the LMP) was vaccinated subcutaneously in the left arm with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 648671/1070P). It was reported that the patient was pregnant. Medical attention was not sought. There was no product quality complaint involved. Follow up information from the health professional indicated that she had limited information about the patient as she was seen at an immunization clinic. Follow up information received from a medical assistant indicated that the patients pregnancy was confirmed on Sept 2 2005 by a positive home pregnancy test. Her LMP was Jul 24 2005 and the EDD was April 30 2006. The patient had her first trimester ultrasound on Sept 27 2005 (9 weeks from her LMP). The results of the test were reported as follows single intrauterine pregnancy. Crown rump length of 4mm. Corresponds with 6 week gestational age. Minimal chorioamniotic separation, too early to determine viability. It was reported that the patient had a spontaneous abortion at 9-10 weeks. The patient did not take any prescriptions drugs during her pregnancy, but did take pre natal vitamins. Upon internal review spontaneous abortion was considered to be an other important medical event (OMIC). Additional information has been requested.
VAERS ID: 249306   Vaccination Date: 2005-11-29
Age: 35.0   Onset Date: 2005-12-09   Days later: 10
Gender: Female   Submitted: 2005-12-09
State: Mississippi   Entered: 2005-12-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: MORNING SICKNESS
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: 5-6 WEEKS PREGNANT
CDC 'Split Type': MS05027
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU AVENTIS PASTEUR U1806AA   IM LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Asthenia
Write-up: PT STATES: "AFTER FLU SHOT MY BODY WAS WEAK AND I WAS DRAGGING FOR 2 DAYS'. 12/9/2005 PT WENT FOR SONOGRAM M D AND FOUND NO HEARTBEAT OF FETUS.
VAERS ID: 249972   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender:    Submitted: 2005-12-28
State: North Carolina   Entered: 2006-01-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': 200502820
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU AVENTIS PASTEUR       UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Seriousness criteria other medically significant (OMIC). This case involves a cluster of five female (no specific identification provided). The patients had all received vaccinations with Fluzone SV 2005-2005 USP on unspecified dates. The vaccines were received at the local health department and were from three different lots. No information on the specific lot numbers was provided. An unspecified amount of time following vaccination, the five women experienced intra-uterine fetal death. Two of the patients were sisters. Of the five total patients, two of the fetuses were at 37 to 40 weeks gestation at the time of fetal death, and three were 20 to 36 weeks. There was no available information on the causes of deaths in the fetuses or if autopsies are planned. It was not reported whether any of the five female patients recovered from the events.
VAERS ID: 250386   Vaccination Date: 2005-09-08
Age: 32.0   Onset Date: 2005-10-05   Days later: 27
Gender: Female   Submitted: 2006-01-12
State: Unknown   Entered: 2006-01-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: Bitten by a rabid dog.
CDC 'Split Type': MA20060004
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB CHIRON CORPORATION   4 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Multiple pregnancy
Write-up: A 32 year old female patient, born on Sept 1 1973 was vaccinated with 1 ml RabAvert IM on Aug 11, 14, 18, 25 2005 and on Sept 8 2005. On Aug 11 2005 the patient also got HRIG. Patient was bitten by the family dog who was determined to be rabid. On Sept 2 2005 the patient was found to be pregnant with twins. She lost pregnancy and had dilation and curettage on Oct 5 2005. Seriousness criterion: medically significant (OMIC). Causality not related. Drug exposure during pregnancy is expected, abortion is unexpected, after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
VAERS ID: 251662   Vaccination Date: 2005-11-01
Age: 20.0   Onset Date: 2005-11-17   Days later: 16
Gender: Female   Submitted: 2006-02-15
State: Missouri   Entered: 2006-02-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: The patient took a pregnancy test on 11/2/2005 and it was positive for pregnancy.
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': 200502308
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ AVENTIS PASTEUR U1784AA   IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Initial report received on 11/2/2005 from a health care professional. A 20 year old pregnant female with no significant medical history received an intramuscular injection of Menactra, lot number U1784AA on 11/1/2005. On 11/2/2005 she took a pregnancy test and it was positive. Her last menstrual period was on 9/23/2005. The patients past obstetrical history is negative for any previous pregnancies. Seriousness criteria other medically significant (OMIC). Follow up information received on 2/13/2006 from a health care professional Per the reporter, the patient had a miscarriage the week of 11/17/2005. No other information was provided. The case was upgraded to seriousness bases on this new information.
VAERS ID: 252734   Vaccination Date: 1994-01-07
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2006-03-10
State: Unknown   Entered: 2006-03-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions:
CDC 'Split Type': WAES0602USA05908
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Injury, Unintended pregnancy
Write-up: Information has been received regarding a case in litigation concerning a female who on 07-Jan-1994 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. On an unspecified date, the woman became pregnant. It was not reported if the patient was pregnant on the date of vaccination. It was reported that the patient suffered injuries (not specified) and her "fetus suffered death." Intra-uterine death was considered to be an other important medical event (OMIC). No further information was provided.
VAERS ID: 255432   Vaccination Date: 2005-06-01
Age: 35.0   Onset Date: 2005-06-01   Days later: 0
Gender: Female   Submitted: 2006-05-11
State: Massachusetts   Entered: 2006-05-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy NOS LMP 5/15/2005.
CDC 'Split Type': WAES0506USA04144
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC. 0827P     UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Information has been received through the pregnancy registry from a physician concerning a 35 year old female who on 6/1/2005 was vaccinated with a dose of varicella virus vaccine live (lot 648933/0827P). It was reported that the patient was definitely pregnant, with an LMP of 5/15/2005. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information received from a physician indicated that the patient was tested for varicella antibodies before vaccination, and the results were negative. It was noted that she had one previous pregnancy. No birth defects occurred in any previous pregnancy. No stillbirth or miscarriage occurred in any previous pregnancy. There was no local reaction at the vaccination site. There were no varicella or herpes zoster symptoms post vaccination. The reporter indicated that the patient lost the pregnancy in the first trimester. Upon internal review, the loss of pregnancy was considered to be an other important medical event (OMIC). No additional information is expected.

 

VAERS ID: 259192   Vaccination Date: 2006-03-01
Age: 20.0   Onset Date: 2006-05-22   Days later: 82
Gender: Female   Submitted: 2006-07-05
State: Unknown   Entered: 2006-07-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Blood human chorionic gonadotr 06/09/2006 96 UI/L low 15 (normal 3-4W) High 150 (normal 3-4W); Pregnancy test positive 05/29/2006; Urine pregnancy test doubtful 06/06/2006,
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0428352A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal, Pelvic pain, Thrombosis, Vaginal haemorrhage
Write-up: This 20-year-old female subject was enrolled in a blinded study (580299 099) for the prophylaxis of cervical intraepithelial neoplasia (CINII) associated with human papillomavirus (HPV); 16 and/or HPV-18 in health young females. The subject received intramuscular investigational product single dose on 09/21/2005, 11/01/2005 and 03/01/2006 after negative urine pregnancy test. Site of injection was the left deltoid. On 09/21/2005, 11/01/2005 and 03/01/2006, the subject received the first, second and third intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug AL (OH) 3. Lot number was not provided. On 05/22/2006, 82 days after the third dose of Blinded vaccine, this 20-year-old subject developed abundant vaginal bleeding with clots associated with pelvic pain. (last menstrual period: 03/15/2006, the subject was exposed to the vaccine before conception). On 05/28/2006, the vaginal bleeding stopped. On 05/09/2006, the subject performed a blood pregnancy test which was positive. the microbiologist indicated that the result was only slightly positive and recommended her to visit a doctor because it could be a miscarriage. The subject didn't consult a doctor because the vaginal bleeding stopped on 05/28/2006 and she felt well. On 06/05/2006, she was evaluated by the study doctor. He documented a closed, formed cervix, without vaginal bleeding, an uterus with normal height and doubtful urine pregnancy test (non serous adverse event). On 06/09/2006, when she was 12+1 weeks pregnant according to the date of last menstrual period, a quantified HCG test was performed. On 06/20/2006, the result of this test was received: 96 UI/L (normal values after 3-4 weeks pregnancy: 15-150 UI/L). The subject was finally diagnosed as having had a complete spontaneous miscarriage since she presented with vaginal bleeding and a positive blood
VAERS ID: 261076   Vaccination Date: 2006-05-08
Age: 17.0   Onset Date: 2006-05-27   Days later: 19
Gender: Female   Submitted: 2006-08-01
State: Kansas   Entered: 2006-08-04
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: The patient had a positive pregnancy test on an unspecified date. A copy of the surgical pathology report dated 5/27/06 was provided. Products of conception was submitted for examination and were determined to consist of gestational endomet
Previous Vaccinations:
Other Medications:
Preexisting Conditions: The patient has no past medical history, illness or allergies. From follow up information received on 7/24/06, it was reported that it is unknown whether the patient had ever experienced any adverse event following prior vaccination. The date of the patients last menstrual period was in Feb 2006 and her estimated date of delivery was in Nov 2006. She had no history of previous preg
CDC 'Split Type': 200601075
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ AVENTIS PASTEUR U1769A 0   RA
TDAP GLAXOSMITHKLINE BIOLOGICALS ACSB004AB 5   LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Endometritis decidual, Inflammation, Necrosis, Thrombosis, Unintended pregnancy, Vaginal haemorrhage
Write-up: Initial report received from a healthcare provider on 5/9/06. A 16 year old female patient had received a right deltoid injection of Menactra, lot number U1769AA, and a left deltoid injection of Boostrix, lot number ACSB004AB, on 5/8/06. The patient had no period for two months and was referred to an OB.GYN for pregnancy follow up. An estimated date of delivery was not provided. Per the reporter, there was no adverse event. Follow information received on 6/26/06. Per the reporter, the patient was not evaluated in their medical office. Follow up information received on 7/24/06. The date of the patients last menstrual period was in Feb 2006 and her estimated date of delivery was in Nov 2006, She had no history of previous pregnancies. On 5/27/06, 19 days post vaccination, the patient was seen by a physician for bleeding during pregnancy. She was determined to be having a spontaneous abortion (less than 20 weeks gestation). A copy of the surgical pathology reported dated 5/27/06 was provided. Products of conception was submitted for examination and included were portions of blood clot. Chorionic villi were not identified. No changes were present to suggest malignancy. The patient has no known maternal drug exposure. She had no exposure to alcohol, tobacco or recreational drugs during her pregnancy. It was not reported whether the patient recovered from the event. Based upon the new information provided in this follow up report, this case is being upgraded to serious (OMIC).
VAERS ID: 261285   Vaccination Date: 2006-04-28
Age: 26.0   Onset Date: 2006-05-30   Days later: 32
Gender: Female   Submitted: 2006-08-04
State: Nevada   Entered: 2006-08-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Ibuprofen
Preexisting Conditions: The pt has a history of motor vehicle accident in 2004 with a spinal fracture and splenectomy. She also has a history of three previous pregnancies resulting in two full term deliveries.
CDC 'Split Type': 200601336
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ AVENTIS PASTEUR U1809A 0 IM RA
Administered by: Other     Purchased by: Public
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Due to medical evaluation of new information received for this case on 7/31/06, this case had been upgraded to serious (OMIC). Initial report received from a health care provided on 6/1/06. A 26 year old female pt had received an IM, right deltoid injection of Menactra, lot number U1809AA, on 4/28/06. It was subsequently determined that the pt was pregnant. The pts last menstrual period was 4/2/06. An ultrasound ordered secondary to spotting and to confirm pregnancy, on 5/30/06, showed a nine week pregnancy. Per the reporter, the pt had three previous pregnancies resulting in two full term deliveries. The outcome of the third pregnancy was not reported. The estimated date of delivery was not reported. Per the reporter, there was no adverse event. Follow up information received on 7/31/06. The vaccination with Menactra on 4/28/06 was the first dose for the pt. The pt had no illness at the time of that vaccination. Per the reporter, the date of the pts last menstrual period was on 4/26/06, not 4/2/06 as previously reported. The pts expected date of delivery was to be 1/1/07. The pt has not received any treatment for infertility and it was reported she had a history of 5 previous pregnancies, with three live births and one spontaneous abortion prior to 20 weeks gestation. The outcome of the fourth pregnancy was not reported. This pregnancy ended in a first trimester, incomplete, spontaneous abortion of one single fetus on 5/30/2006, 32 days post immunization. The pt subsequently had a D&C of the uterus on 6/23/06. Per the reporter, there were no known risk factors or health problems during this pregnancy. The pt had one prenatal visit with a physician.
VAERS ID: 264826   Vaccination Date: 2006-05-23
Age: 22.0   Onset Date: 2006-06-01   Days later: 9
Gender: Female   Submitted: 2006-10-13
State: Nebraska   Entered: 2006-10-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: 6/1/06 quantitative HCH level was decreased.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: The patient has a history of endometriosis and poly cystic ovaries. She had one previous pregnancy resulting in a spontaneous abortion. She had no illness at the time of vaccination.
CDC 'Split Type': 200601345
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP AVENTIS PASTEUR       UN
Administered by: Public     Purchased by: Unknown
Symptoms: Abortion spontaneous, Laboratory test abnormal, Placental disorder, Unintended pregnancy
Write-up: Seriousness criteria other medically significant (OMIC). Initial report received on 6/5/06 from a health care provider. A 22 year old female pt, with a history of endometriosis and polycystic ovaries, had received an injection of Adacel, lot number not reported, on 5/23/06. Route and site of administration were not reported. It was later determined that the pt was pregnant. Date of last menstrual period was 5/28/06, and the pts estimated date of delivery is 2/2/07. Per the reporter, lab work showed a low progesterone. It was indicated that the pt was placed on progesterone 200 mg, two times a week, to maintain the pregnancy. The reporter was not aware of any adverse events related to vaccination. Follow up information received on 10/6/06. This case was upgraded to serious as based upon the new information received. It was reported that the pt received the Adacel vaccine as a requirement for work. The had been maintained on progesterone 200 mg IM from 5/31/06 to 6/2/06 due to placental insufficiency. A quantitative HCG level was decreased on 6/1/06. Her past obstetric history was reported as negative, although prior information noted she had one previous pregnancy which resulted in spontaneous abortion. The pt experienced a spontaneous abortion on 1/9/06. Her recovery status was not reported.
VAERS ID: 267797   Vaccination Date: 2006-07-14
Age: 32.0   Onset Date: 2006-09-03   Days later: 51
Gender: Female   Submitted: 2006-11-21
State: Illinois   Entered: 2006-11-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: 9/3/06 ultrasound showed a non viable pregnancy, Suction D&C was performed.
Previous Vaccinations:
Other Medications: Tubersol, Prenatal vitamins
Preexisting Conditions: Per the reporter, the pt has an allergy to sulfa drugs, and denies any other medical history. The pt has had one previous pregnancy that was a normal full term delivery. The date of the pts last menstrual period was on 6/18/06, and her expected date of delivery is 3/25/07. From new information received on 9/21/06, the pt had no illnesses at the time of the vaccination on 7/14/06.
CDC 'Split Type': 200601814
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP AVENTIS PASTEUR C2492BA   IM LA
Administered by: Private     Purchased by: Private
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Seriousness criteria other medically significant (OMIC). Initial report received on 7/17/06 from a physician. A 32 year old female pat whose past medical history included the current pregnancy, and one previous pregnancy that was a normal full term delivery, and allergy to sulfa drugs had received an IM dose of Adacel, lot number C2492BA, in the left deltoid, and a dose of Tubersol 5TU, lot number C2214AB, on 7/14/06 as a pre employment requirement. The route and site of administration of the Tubersol was not reported. The date of the pts last menstrual period was on 7/18/06, and her expected date of delivery is 3/25/07. At the time of this report, the pt was taking prenatal vitamins and was seeing her primary care physician. The pt had not established an OBGYN physician to follow her pregnancy care. Per the reporter, the pt had no experienced any adverse events since the Adacel and Tubersol administration on 7/14/2006. Follow up information received on 9/21/06. Per the reporter, the pt did not have any illnesses at the time of the vaccination on 7/14/06. The Tubersol 5 TU was administered Intra dermally on 7/14/06. The site of administration was not reported. Follow up information received on 11/20/06. The pt received the Tubersol 5 TU vaccine in the left forearm. On 9/3/06, 51 day post immunization, the pt experienced a spontaneous abortion at less than 20 weeks gestation. An ultrasound performed that day, showed a non viable pregnancy and a suction D and C was performed. The recovery status of the pt is unk.
VAERS ID: 269659   Vaccination Date: 2006-11-10
Age: 16.0   Onset Date: 2006-11-10   Days later: 0
Gender: Female   Submitted: 2006-12-12
State: Tennessee   Entered: 2006-12-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Non-Hodgkin's lymphoma
Diagnostic Lab Data: Pregnancy test 10/05/06 negative, pregnancy test blood 11/13/06 positive, pregnancy test urine 11/10/06 weakly positive, 12/01/06 negative, Ultrasound 12/09/06 spontaneous abortion.
Previous Vaccinations:
Other Medications: FluMist or Placebo mist, Methotrexate, 6 Mercaptopurine, Septra, Lidocaine cream, Ondansetron, Hydrocortisone, Cytarabine.
Preexisting Conditions:
CDC 'Split Type': MEDI0005227
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN MEDIMMUNE, INC./WYETH LABORATORIES, INC     IN  
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy, Vaginal haemorrhage
Write-up: On 01 Dec 2006, 57 days after receiving FluMist therapy, a 16-year old female patient with non-Hodgkin's lymphoma experienced a spontaneous abortion. The patient was a participant in the study and received study vaccine as either FluMist or placebo vaccine on 05 Oct 2006. The patient was administered FluMist as annual flu vaccine 10 Nov 2006 by her primary oncology attending physician. On 10 Nov 2006, the results of a routine urine pregnancy test were weakly positive. A repeated pregnancy test in the blood conducted on 13 Nov 2006 showed a positive result. The patient was estimated to be in the first trimester and the last menstrual period was not known. The patient's methotrexate therapy was stopped on 10 Nov 2006 and 6-mercaptopurine therapy was stopped on 13 Nov 2006, due to the pregnancy. On 01 Dec 2006, the patient experienced vaginal bleeding lasting for two to three days. A urine pregnancy test was negative on 01 Dec 2006. On 09 Dec 2006, the patient was seen in a local clinic where an ultrasound indicated that the patient had experienced a spontaneous abortion around 01 Dec 2006. The chemotherapy treatment with methotrexate and 6-mercaptopurine was resumed on 11 Dec 2006. The reporter assessed the event of spontaneous abortion as not related to FluMist therapy, but rather to the patient's methotrexate and 6-mercaptopurine therapy. (OMIC)
VAERS ID: 273848   Vaccination Date: 0000-00-00
Age:    Onset Date: 2007-02-28   Days later:
Gender: Female   Submitted: 2007-03-12
State: Unknown   Entered: 2007-03-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = unknown).
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions:
CDC 'Split Type': WAES0703USA00274
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion, Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse through a pregnancy registry concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. The patient was pregnant, and on 28-FEB-2007 the patient had a miscarriage or abortion after receiving the first dose of Gardasil. The patient sought unspecified medical attention. At the time of this report, the nurse was unsure if the patient had a miscarriage or abortion. Upon internal review, the patient's miscarriage or abortion was considered an other important medical event. Additional information has been requested.
VAERS ID: 274754   Vaccination Date: 0000-00-00
Age: 26.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-03-23
State: Ohio   Entered: 2007-03-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions:
CDC 'Split Type': WAES0702USA03451
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1    
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician, for the Pregnancy registry for Gardasil, concerning a 26 year old female with pertinent medical history and drug reactions/allergies unspecified who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported) injection. On an unspecified date, the patient was vaccinated with second dose of Gardasil (lot # not reported) injection. Concomitant therapy was unspecified. Approximately two weeks after receiving the second dose of vaccine, the patient learned that she was pregnant. The patient sought medical attention, she reported the pregnancy to the physician's office. The date of last menstrual period was not reported. The third dose of Gardasil will not be given to the patient during her pregnancy. The patient has not had any adverse experiences to date. Additional information was received from the physician who reported that the patient had a miscarriage. No further information was available at the time of reporting. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 274938   Vaccination Date: 2007-01-11
Age: 20.0   Onset Date: 2007-01-11   Days later: 0
Gender: Female   Submitted: 2007-03-26
State: Georga   Entered: 2007-03-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown) Drug hypersensitivity
Diagnostic Lab Data: urine beta-human 01/11/07 - Not pregnant
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0703USA02391
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0   UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin negative
Write-up: Information has been received from a 20 year old female with an allergy to Zomig and a history of multiple miscarriages. On 11-JAN-2007 the patient was vaccinated with her first dose of Gardasil when she was 4 and a half weeks pregnant. The patient took a urine Human chorionic gonadotropin (HCG) test in the doctor's office that said she was not pregnant, and they administered the vaccination on day. On 17-JAN-2007 the patient discovered she was pregnant. On 21-JAN-2007 she had a miscarriage. Medical attention was sought. Her outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested. Additional information has been requested.
VAERS ID: 274942   Vaccination Date: 0000-00-00
Age: 19.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-03-26
State: Arizona   Entered: 2007-03-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0703USA04238
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0   UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a medical assistant through a pregnancy registry concerning a 19 year old female with a history of miscarriage who was vaccinated with the first dose of Gardasil. It was reported that later the patient found out that she was pregnant. The patient was 2 months pregnant at the time of the vaccination. It was reported that the patient miscarried 2 weeks after the vaccination. At the time of the report it was unknown, if the patient recovered. Upon internal review, it was determined that miscarried was an other important medical event. Additional information has been requested.

 

VAERS ID: 275702   Vaccination Date: 0000-00-00
Age:    Onset Date: 2007-02-01   Days later:
Gender: Female   Submitted: 2007-04-05
State: Minnesota   Entered: 2007-04-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0703USA05521
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0   UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received through the pregnancy registry from a physician concerning a female teenager who was vaccinated with a first dose of Gardasil without the knowledge that she was pregnant. It was found out that the patient was pregnant after the administration of the vaccine. Later the patient had a miscarriage. As per the reporter, the miscarriage happened "last month or so." Medical attention was sought. The patient was recovering. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 275779   Vaccination Date: 2006-11-28
Age: 23.0   Onset Date: 2007-01-31   Days later: 64
Gender: Female   Submitted: 2007-04-06
State: Illinois   Entered: 2007-04-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/31/2007)
Diagnostic Lab Data: Diagnostic laboratory 02/26/07, gynecological 02/26/07, ultrasound 02/26/07
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0704USA00075
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0688F 1 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Gynaecological examination, Laboratory test, Ultrasound scan
Write-up: Information has been received from a consumer and a licensed practical nurse, through the pregnancy registry, concerning a 23 year old female, who was vaccinated on 28-SEP-2006 with the first dose of Gardasil, and on 28-NOV-2006 with the second dose of Gardasil (Lot # 653735/0688F). There was no concomitant medication. The nurse reported that on 26-FEB-2007 (consumer reported as 13-MAR-2007, "some time after"she received the second dose) the patient had a miscarriage. The date of the last LMP was approximately 31-JAN-2007 ("late January"). According to the consumer, lab diagnostic tests included "several blood tests, ultrasounds, vaginal probe" (results not provided). On 29-MAR-2007, the third dose of Gardasil (Lot # 654389/0961F) was administered to the patient, and the nurse reported the patient "was fine" at that visit. The miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 276315   Vaccination Date: 2006-12-20
Age: 26.0   Onset Date: 2007-01-01   Days later: 12
Gender: Female   Submitted: 2007-04-13
State: Unknown   Entered: 2007-04-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: hormonal contraceptives
Preexisting Conditions:
CDC 'Split Type': WAES0704USA00625
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse for the Pregnancy registry for Gardasil concerning a 26 year old female who on 20-DEC-2006 was vaccinated IM with the second 0.5 mL dose of Gardasil. The patient was vaccinated with the first 0.5 mL dose Gardasil (lot # 653937/0637F) on 27-OCT-2006. Concomitant therapy included hormonal contraceptives (unspecified). In January 2007, the patient became pregnant. In March 2007, the patient had a miscarriage at 8 weeks gestation. The patient sought unspecified medical attention. Subsequently, the patient recovered. Upon internal review, the patient's miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 277166   Vaccination Date: 2007-03-27
Age: 26.0   Onset Date: 2007-03-27   Days later: 0
Gender: Female   Submitted: 2007-04-20
State: Unknown   Entered: 2007-04-23
Life Threatening Illness? Yes
Died? No
Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: pelvic ultrasound 04/09/07 spontaneous abortion; complete blood cell Result not reported; total serum human 03/28/07 positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0704USA02270
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1   UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Full blood count, Pregnancy test positive, Ultrasound scan, Uterine dilation and curettage, Vaginal haemorrhage, Vaginitis bacterial
Write-up: Information has been received from a physician for the Pregnancy registry for GARDASIL, concerning a 26 year old female patient with a history of first trimester miscarriage in 2006 who on 25-JAN-2007 was vaccinated IM with a first dose of HPV. The physician reported that on 27-MAR-2007 the patient was vaccinated with second dose of HPV and had a positive pregnancy test the next day. The patient presented to the physician's office on 09-APR-2007 with vaginal bleeding and a pelvic ultrasound determined that she was suffering a spontaneous abortion. She was at 6 weeks gestation. The patient was admitted to the hospital on the night of 09-APR-2007 with severe vaginal hemorrhaging and underwent an emergency dilation and curettage procedure. The patient was recovering without complication. The physician added that, on 27-MAR-2007, the patient was diagnosed with bacterial vaginosis but she did not take the prescribed treatment. The physician considered spontaneous abortion to be significantly disabling and life threatening. Additional information has been requested.
VAERS ID: 277408   Vaccination Date: 0000-00-00
Age: 17.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-04-25
State: Unknown   Entered: 2007-04-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions: The subject's medical history, concurrent conditions, and concurrent medications were not provided.
CDC 'Split Type': A0648430A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP GLAXOSMITHKLINE BIOLOGICALS       UN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Vaginal haemorrhage
Write-up: This case was reported by a healthcare professional and described the occurrence of miscarriage in a 17-year old female subject who was vaccinated with Boostrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received n unspecified dose of Boostrix (unknown). The subject participated in an observational study, 100454. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject became pregnant. This was her first pregnancy. The subject was seen in the emergency room for vaginal bleeding and abdominal pain at approximately seven weeks of pregnancy. Per the reporter, "this would indicate that she was vaccinated approximately 13 days prior to the last menstrual period prior to her pregnancy". On an unspecified date, an unspecified time after vaccination with Boostrix, the subject had a miscarriage. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events were was unspecified.
VAERS ID: 277668   Vaccination Date: 2007-02-09
Age: 16.0   Onset Date: 2007-02-09   Days later: 0
Gender: Female   Submitted: 2007-04-30
State: Indiana   Entered: 2007-05-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/5/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0704USA04977
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0   UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Benign hydatidiform mole, Blighted ovum, Drug exposure during pregnancy
Write-up: Information has been received via the pregnancy registry, from a consumer concerning her 16 year old daughter, who was pregnant with an estimated date of conception on 05-JAN-2007, and on 09-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. On 29-MAR-2007, the mother reported that her daughter, who was then "12 weeks pregnant," experienced a miscarriage; the mother added that the pregnancy was considered to be a blighted ovum, which she also referred to as a "mole pregnancy." The mother added that in April 2007, her daughter received the second dose of Gardasil. At the time of this report, it was unknown if the patient had recovered from the events. Upon internal review, blighted ovum, "mole pregnancy" and miscarriage were determined to be an other important medical event. Additional information has been requested.
VAERS ID: 278380   Vaccination Date: 2006-10-31
Age: 25.0   Onset Date: 2006-11-11   Days later: 11
Gender: Female   Submitted: 2007-05-10
State: Tennessee   Entered: 2007-05-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 11/11/2006)
Diagnostic Lab Data: beta-human chorionic 12/18/06 - Positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0705USA00787
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0800F 1 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received via the manufacturer pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F). On 18-DEC-2006, the patient had a positive pregnancy test; the date of the LMP was 11-NOV-2006, with an estimated date of delivery of 18-AUG-2007. The CMA confirmed that on 22-DEC-2006, the patient had a spontaneous miscarriage, through hospitalization was not reported and testing of the miscarried fetus was unavailable. It was not specified if the patient sought medical attention, nor if the patient had recovered from the spontaneous abortion. On 27-DEC-2006, the patient was vaccinated IM, with the second dose of Gardasil (Lot #654540/0800F). Upon internal review, spontaneous miscarriage was determined to be an other important medical event. This patient also experienced a pregnancy following vaccination with the second dose of Gardasil (WAES #0705USA01062). Additional information has been requested.
VAERS ID: 278785   Vaccination Date: 2006-12-08
Age: 23.0   Onset Date: 2006-12-14   Days later: 6
Gender: Female   Submitted: 2007-05-16
State: Wisconsin   Entered: 2007-05-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: beta-human chorionic 12/14/06 - positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Pregnancy NOS (LMP = 11/16/2006)
CDC 'Split Type': WAES0612USA02963
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Initial and follow up information has been received from a nurse and manufacturer pregnancy registry concerning a 23 year old black female patient with one previous pregnancy who on 08-DEC-2006 was vaccinated with a dose of Gardasil. On 14-DEC-2006 a pregnancy test was positive. The patient's LMP was late November 2006. On 07-MAY-2007 the nurse reported that the patient had not been to the office since the original prenatal appointment on 12-FEB-2007. She had cancelled 3 appointments on 05-March-2007, 12-MAR-2007 and 19-MAR-2007. Follow up information from the nurse indicated that on 16-NOV-2006 patient had her last menstrual period and her estimated delivery date 20-AUG-2007. She called back on 07-MAY-2007 but did not give any information about the miscarriage. On 24-APR-2007 patient reported that she had miscarried. No date was identified when the patient miscarried. Unspecified medical attention was sought. The outcome was unknown. Upon internal review, miscarriage was considered an other important medical event. Additional information has been requested.
VAERS ID: 279251   Vaccination Date: 2006-09-13
Age: 26.0   Onset Date: 2007-05-11   Days later: 240
Gender: Female   Submitted: 2007-05-21
State: Unknown   Entered: 2007-05-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown); Drug hypersensitivity; Factor V Leiden mutation; 5-alpha reductase deficiency; Prothrombin level
Diagnostic Lab Data: ultrasound 04/16/07 - + pregnancy confirmed, ultrasound 05/11/07 - positive miscarriage, beta-human chorionic 04/16/07 - + pregnancy confirmed
Previous Vaccinations:
Other Medications: Clonazepam, Topamax, Coumadin
Preexisting Conditions: Pulmonary embolism; Deep vein thrombosis; Herpes virus infection
CDC 'Split Type': WAES0705USA02904
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0688F 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Ultrasound abdomen
Write-up: Information has been received from a registered nurse for the pregnancy registry for Gardasil, concerning a 26 year old female with a drug reaction/allergy to Wellbutrin, factor v laiden mutation/clotting disorder, prothrombin mutation, bipolar disorder, seizure disorder and Mthfr and a history of pulmonary embolism and multiple deep vein thrombosis and herpes virus infection who on 13-SEP-2006 was vaccinated with her first Gardasil 0.5 ml IM (lot # 653735/0688F). Concomitant therapy included Coumadin, Topamax and clonazepam. The nurse stated that the patient was very non-complaint and never returned for the second or third dose of the vaccine. On 16-APR-2007, the patient was found to be pregnant which was confirmed by ultrasound and a pregnancy test. The patient's last menstrual period, gestational age or due date were not reported. On 11-MAY-2007 the patient experienced spontaneous miscarriage which was confirmed by ultrasound. The patient sought unspecified medical attention. The patient was not hospitalized. Upon internal review, spontaneous miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 279424   Vaccination Date: 2006-11-30
Age: 26.0   Onset Date: 2006-12-26   Days later: 26
Gender: Female   Submitted: 2007-05-23
State: Unknown   Entered: 2007-05-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: beta-human chorionic 01/30/07 5 weeks pregnant
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Asthma
CDC 'Split Type': WAES0702USA04650
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pregnancy, Surgery, Uterine dilation and curettage
Write-up: Information has been received from a registered nurse through the manufacturer pregnancy registry concerning a 26 year old female patient, with a "history of asthma in 1999," who on 30-NOV-2006 was vaccinated with the first dose, 0.5ml, of Gardasil. The nurse stated that the patient reported she was "5 weeks pregnant" on 30-JAN-2007. Pregnancy was confirmed via pregnancy test (not specified). The approximate date of conception was 26-DEC-2006, with an estimated due date of 02-OCT-2007. On 22-FEB-2007, at approximately 8 weeks of pregnancy, the patient "had a miscarriage." The patient went to the emergency room (ER) on 22-FEB-2007 due to the miscarriage, but she was not admitted. On 23-FEB-2007, the patient had a dilatation & curettage (D & C) performed. The nurse reported that the patient "was not seen in the physician office for her pregnancy," and added that she "had recovered from the events" (date not specified). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.

 

VAERS ID: 280234   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-06-01
State: Tennessee   Entered: 2007-06-04
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0705USA05018
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician for the pregnancy registry for Gardasil concerning a female who was vaccinated with an unknown number of 0.5 mL doses of Gardasil. "A few weeks ago," the patient developed a miscarriage in the first trimester. The patient's outcome was unknown. Upon internal review, the patient's spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 281537   Vaccination Date: 2007-04-25
Age: 17.0   Onset Date: 2007-04-25   Days later: 0
Gender: Female   Submitted: 2007-06-12
State: Michigan   Entered: 2007-06-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/28/2007); Allergic reaction to antibiotics
Diagnostic Lab Data: total serum human -
Previous Vaccinations:
Other Medications: none
Preexisting Conditions:
CDC 'Split Type': WAES0706USA00513
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a registered nurse concerning a 17 year old female patient with a drug allergy to erythromycin and no medical history, who on 21-FEB-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (Lot# 655324/0089U). There was no concomitant medication. On 25-APR-2007 the patient received her second dose of the vaccine while pregnant (LMP 28-MAR-2007). On 16-MAY-2007, the patient experienced an uncomplicated spontaneous miscarriage. Unspecified medical attention was sought. It was reported that the patient has not required any treatment and has not experienced any further problems. Laboratory diagnostic studies included a quantitative HCG. At the time of this report, the patient was recovering. No product complaint was involved. Upon internal review, uncomplicated spontaneous miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 282370   Vaccination Date: 2007-02-19
Age: 20.0   Onset Date: 2007-04-04   Days later: 44
Gender: Female   Submitted: 2007-06-19
State: Texas   Entered: 2007-06-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 4/4/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN LO
Preexisting Conditions:
CDC 'Split Type': WAES0706USA01990
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0688F 0 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse concerning a 20 year old female with no relevant medical history who on 19-FEB-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot 653735/0688F). Concomitant therapy included Ortho Tri-Cyclen Lo. Subsequently, she became pregnant. Date of LMP was 04-APR-2007. The patient subsequently miscarried. The patient was seen in the emergency room on 14-MAY-2007 for the miscarriage. She was not admitted to the hospital. The patient called the office on 17-MAY-2007 to notify the physician of the miscarriage, but had not returned to the office for follow-up visits. Upon internal review, the patient's spontaneous abortion was considered an other important medical event. Additional information has been requested.
VAERS ID: 282412   Vaccination Date: 2007-04-24
Age: 37.0   Onset Date: 2007-06-13   Days later: 50
Gender: Female   Submitted: 2007-06-20
State: Virginia   Entered: 2007-06-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: None
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC. 1142f 0 SC RA
Administered by: Public     Purchased by: Private
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Client had live vaccine on April 24. Patient returned for second dose of vaccine on June 19. Reported to nurse that discovered she was pregnant right after received first vaccination, but was unaware of pregnacny at time of vaccination. Patient reports spontaneous abortion at apporoximately 6 weeks gestation on June 13.
VAERS ID: 282645   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-06-21
State: Unknown   Entered: 2007-06-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: (therapy unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0706USA02595
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
MMR MERCK & CO. INC.     UN UN
UNK UNKNOWN MANUFACTURER     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a female patient who was vaccinated with a dose of Gardasil. Concomitant suspect therapy included a dose of M-M-R II. Other concomitant therapy included "other unspecified vaccines". The reporter mentioned that the patient was pregnant but miscarried after receiving Gardasil. Unspecified medical attention was sought. No additional information was available. Upon internal review, miscarriage was determined to be an other Important Medical Event. Additional information has been requested.
VAERS ID: 283644   Vaccination Date: 2007-05-10
Age: 31.0   Onset Date: 2007-03-26   Days later: -45
Gender: Female   Submitted: 2007-07-02
State: Unknown   Entered: 2007-07-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/26/2007)
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0705USA02762
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0389U 1 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Write-up: Initial and follow up information has been received through the Merck pregnancy registry, from a 31 year old female healthcare professional, who on 10-MAY-2007 (previously reported as 30-APR-2007), was vaccinated intramuscularly with the second dose of Gardasil (Lot #657736/0389U), and recently found out she was pregnant. The date of the LMP was reported as 26-MAR-2007, with an estimated delivery date on 31-DEC-2007. Unspecified medical attention was sought. It was not known if the patient had been seen by OB/GYN. Follow up information from the healthcare professional, stated that she "had a miscarriage." No further information or details were provided. Upon internal review, "had a miscarriage" was considered to be serious as an other significant medical event. Additional information has been requested.
VAERS ID: 283826   Vaccination Date: 2007-05-03
Age: 17.0   Onset Date: 2007-05-21   Days later: 18
Gender: Female   Submitted: 2007-07-03
State: Kansas   Entered: 2007-07-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 4/15/2007) Folliculitis; Genital wart
Diagnostic Lab Data: Ultrasound 05/21/07 - 5 week gestational sac Reason for test was clotting/spotting, total serum human 05/25/07 - 2231, total serum human 05/30/07 - 118
Previous Vaccinations:
Other Medications: AUGMENTIN mg, trichloroacetic acid
Preexisting Conditions:
CDC 'Split Type': WAES0705USA04344
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0387U 1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Metrorrhagia, Pregnancy test positive, Thrombosis, Ultrasound scan normal
Write-up: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 17 year old female patient with folliculitis, genital condyloma and no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655618/0186U). On 03-MAY-2007 the patient received a second dose of Gardasil (Lot# 657621/0387U). Concomitant therapy included, AUGMENTIN and trichloroacetic acid. The patient stated her last menstrual period was 15-APR-2007. The nurse reported that the patient kept changing the date at each visit. The patient was sent to an OB/GYN and it was determined that she was 4 weeks pregnant as of 21-MAY-2007. Diagnostic laboratory studies performed were an ultrasound on 21-MAY-2007 due to clotting/spotting which resulted as 5 week gestational sac. On 25-MAY-2007 and 30-MAY-2007, HCG quantitative test were performed which resulted as 2231 and 118, respectively. The nurse mentioned that the patient has not experienced any difficulties with the pregnancy as this time. On 27-MAY-2007, it was reported that the patient had a spontaneous abortion. She was 6 weeks from LMP. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 284195   Vaccination Date: 2007-02-26
Age: 22.0   Onset Date: 2007-06-18   Days later: 112
Gender: Female   Submitted: 2007-07-09
State: Unknown   Entered: 2007-07-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 5/14/2007)
Diagnostic Lab Data: Ultrasound - results not provided, Beta-human chorionic - results not provided
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0706USA05115
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0800F 0 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy, Ultrasound scan
Write-up: Information has been received for the Merck Pregnancy Registry from a licensed practical nurse concerning a 22 year old female with no pertinent medical history who on 26-FEB-2007 was vaccinated with 0.5 ml of the first dose of Gardasil (Lot # 654540/0800F). There was no concomitant medication. On 02-MAY-2007, the patient was vaccinated with 0.5 ml of the second dose of the Gardasil (Lot # 656050/0245U). It was reported that the patient was pregnant. Unspecified medical attention was sought. Her last menstrual period was approximately 14-MAY-2007. The estimated date of delivery was 18-FEB-2008. Two ultrasounds were performed (results not provided), and "hormone levels for pregnancy levels dropping was monitored by beta-human chorionic gonadotropin test (bHCG)", On 18-JUN-2007, the patient went to the emergency room and experienced a miscarriage at 5 weeks gestation. It was reported that the patient was recovering. Upon internal review, the miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 284390   Vaccination Date: 2007-04-13
Age: 16.0   Onset Date: 2007-05-01   Days later: 18
Gender: Female   Submitted: 2007-07-11
State: Florida   Entered: 2007-07-12
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: beta-human chorionic 05/01/07 29576 - positive, beta-human chorionic 05/16/07 74136
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0705USA00509
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0137U 0 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Amenorrhoea, Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Initial and follow-up information has been received from a physician for the Pregnancy Registry for Gardasil concerning a 16 year old female with no medical history or previous pregnancies who on 13-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil (lot # 655165/0137U). Concomitant therapy included pre-natal vitamins. On 01-MAY-2007 a pregnancy test was performed because of amenorrhea and found to be positive with an HCG results of 29576. The estimated conception date was 7 weeks and the estimated delivery date was 22-DEC-2007 (LMP was not known). On 16-MAY-2007, an additional HCG test was performed with a result of 74136. The patient sought unspecified medical attention. In May 2007, the patient experienced a spontaneous abortion. It was noted that the patient was currently under a physician's care and that she was permitted to return to normal activities without limitations. At the time of this report, the outcome was unknown. No further information is available.
VAERS ID: 284856   Vaccination Date: 2007-04-03
Age: 26.0   Onset Date: 2007-06-04   Days later: 62
Gender: Female   Submitted: 2007-07-16
State: Unknown   Entered: 2007-07-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: urine beta-human 06/04/07 positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0707USA01083
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ectopic pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a registered nurse concerning a 26 year old female with no relevant medical history reported who on 03-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. There was no concomitant medication. on 04-JUN-2007, the patient returned to the office for her second dose of Gardasil. Dose 2 was not given because she tested positive for pregnancy on that day. In June 2007, the patient had a miscarriage. It was determined that the patient experienced an ectopic pregnancy. The patient returned to the office on 06-JUL-2007 to receive dose 2 of Gardasil. The nurse reported that the patient was "fine now". Upon internal review, ectopic pregnancy and miscarriage were determined to be other important medical events. Additional information has been requested.

 

VAERS ID: 285291   Vaccination Date: 2006-11-01
Age: 15.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-07-19
State: Colorado   Entered: 2007-07-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0707USA01041
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a medical assistant through the Merck pregnancy registry concerning an approximately 15 year old female patient with no pertinent medical history or drug reactions/allergies, who in November 2006, was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml). There was no concomitant medication. It was reported that the patient did not receive her second vaccination due to pregnancy. The patient subsequently had a miscarriage. The date of miscarriage was not known. Upon internal review, the miscarriage was felt to be an other important medical event. Additional information has been requested.
VAERS ID: 286246   Vaccination Date: 2007-06-08
Age: 17.0   Onset Date: 2007-07-17   Days later: 39
Gender: Female   Submitted: 2007-07-23
State: Florida   Entered: 2007-07-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: None
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 14290 0   UN
Administered by: Private     Purchased by: Private
Symptoms: Abortion spontaneous, Endocervical curettage, Pregnancy test positive, Ultrasound uterus, Uterine dilation and curettage
Write-up: Pt was give Gardasil shot June 8-Had positive preg. test June 21. U/S 2 months baby heart beating 2nd U/S no heart beat (7/17 d/c to remove deceased baby) at medical center
VAERS ID: 286711   Vaccination Date: 2007-05-01
Age: 24.0   Onset Date: 2007-05-01   Days later: 0
Gender: Female   Submitted: 2007-08-02
State: South Carolina   Entered: 2007-08-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 6/27/2007)
Diagnostic Lab Data: Serum alpha-human - Quantitative HCG
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0707usa04531
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ectopic pregnancy
Write-up: Information has been received from a Registered Nurse, through the Merck pregnancy registry, concerning a 24 year old female patient who in March 2007, was vaccinated with a first dose of Gardasil and in May 2007 received the second dose of Gardasil. On 25-JUN-2007 Methotrexate was given for treatment of the ectopic pregnancy. Pregnancy was confirmed 1 week before 25-JUN-2007. No further information was available. Upon internal review, ectopic pregnancy, spontaneous abortion was determined to be an other Important Medical Event. Additional information has been requested.
VAERS ID: 287759   Vaccination Date: 2007-03-19
Age: 25.0   Onset Date: 2007-06-24   Days later: 97
Gender: Female   Submitted: 2007-08-09
State: Pennsylvania   Entered: 2007-08-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 6/24/2007)
Diagnostic Lab Data: ultrasound 07/29/07 - no fetus/pregnancy; beta-human chorionic 07/23/07 - positive
Previous Vaccinations:
Other Medications: ZYRTEC; PREVACID
Preexisting Conditions:
CDC 'Split Type': WAES0708USA00038
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0243U 1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Muscle spasms, Ultrasound scan abnormal, Vaginal haemorrhage
Write-up: Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 29-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655617/1447F) injection 0.5mL IM left deltoid. On 19-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # 656372/0243U) injection 0.5mL IM left deltoid. Concomitant medication included ZYRTEC and PREVACID. The date of the patient's last menstrual period was 24-JUN-2007. On 23-JUL-2007, the patient reported that she tested positive for pregnancy. On 29-JUL-2007, the patient sought medical attention for a miscarriage (the estimated date of delivery was 30-MAR-2008). On 29-JUL-2007, the patient arrived at the emergency room with complaints of bleeding and cramping. An ultrasound performed showed no fetus/pregnancy. Additional information was received from the registered nurse via telephone. It was originally reported that the miscarriage was life-threatening. The nurse clarified that it was not life-threatening to the mother but was unknown to the fetus as it was very early on in the pregnancy. The relationship of the miscarriage to Gardasil was unknown. Upon internal review, spontaneous abortion was considered to be an Other Important Medical Event. No additional information is expected.
VAERS ID: 287889   Vaccination Date: 2007-03-09
Age: 24.0   Onset Date: 2007-04-09   Days later: 31
Gender: Female   Submitted: 2007-08-10
State: Unknown   Entered: 2007-08-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = 3/4/2007); Bipolar disorder; Depression; Oedema hands; Foot oedema; Hypertension; Sore throat; Hypothyroidi
Diagnostic Lab Data: beta-human chorionic 04/09/07 posit
Previous Vaccinations:
Other Medications: amoxicillin, carbamazepine, diuretic (unspecified), ORTHO TRI-CYCLEN, ibuprofen, levothyroxine sodium, spironolactone, venlafaxine hydrochloride
Preexisting Conditions: Early onset of delivery
CDC 'Split Type': WAES0708USA00308
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Uterine dilation and curettage
Write-up: Information has been received from an investigator from GLAXOSMITHKLINE (GSK) BIOLOGICS (manufacturer control # B0465767A) regarding a 24 year old female with bipolar disorder, depression, oedema hands and feet, hypertension, sore throat, hypothyroidism and viral infection with a history of 1 pre-term pregnancy and with a normal birth who entered a GSK clinical sponsored trial. On 09-MAR-2007 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Ortho Tri-Cyclen, venlafaxine HCl, spironolactone, levothyroxine Na, carbamazepine, ibuprofen, diuretic (unspecified) and amoxicillin. On 09-APR-2007, a pregnancy test was positive. Her LMP was on 04-MAR-2007 and Ortho Tri-Cyclen, was used for contraception until 16-MAR-2007. On 01-MAY-2007 the patient experienced spontaneous abortion at 8.2 weeks of pregnancy. She was hospitalized for 2 days and the event was considered clinically significant. She was treated with dilation and curettage and the event resolved on 01-MAY-2007. It was noted that her partner had no abnormal medical or family history. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy. The patient was withdrawn from the study due to the spontaneous abortion and subsequent study administration discontinued. No further information is available.
VAERS ID: 288456   Vaccination Date: 2007-07-12
Age: 17.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-08-17
State: Texas   Entered: 2007-08-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0708USA01821
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a health professional concerning a 17 year old female, who on 12-JUL-2007 was vaccinated with a first 0.5mL dose of Gardasil. At the time of the first vaccination the patient was unaware that she was three weeks pregnant. In August 2007 the patient was vaccinated with a second dose of Gardasil. The patient miscarried sometime between the first dose and the second dose. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
VAERS ID: 288686   Vaccination Date: 2007-06-20
Age: 17.0   Onset Date: 2007-08-06   Days later: 47
Gender: Female   Submitted: 2007-08-22
State: North Carolina   Entered: 2007-08-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA MERCK & CO. INC. 0018U 0 IM LA
HPV4 MERCK & CO. INC. 0243U 0 IM RA
Administered by: Private     Purchased by: Public
Symptoms: Abortion spontaneous
Write-up: 8-6-07 Miscarriage
VAERS ID: 288907   Vaccination Date: 2007-07-07
Age: 18.0   Onset Date: 2007-08-08   Days later: 32
Gender: Female   Submitted: 2007-08-23
State: Tennessee   Entered: 2007-08-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 7/11/2007); Penicillin allergy
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0708USA03011
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a licensed practical nurse concerning an 18 year old female with an allergy to penicillin and no medical history, who in June 2007, was vaccinated intramuscularly with a first dose of Gardasil and a second dose in July 2007. There was no concomitant medication. The patient had become pregnant sometime between the two doses. Her last menstrual period was 11-JUL-2007 and her estimated delivery date was 16-APR-2008. On approximately 08-AUG-2007 the patient had a miscarriage. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review spontaneous abortion was considered an other important medical event. Additional information has been requested.
VAERS ID: 289940   Vaccination Date: 2006-12-07
Age: 15.0   Onset Date: 2006-12-08   Days later: 1
Gender: Female   Submitted: 2007-09-05
State: Unknown   Entered: 2007-09-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: beta-human chorionic 12/08/06 - positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0612USA01370
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Abortion spontaneous complete, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a nurse practitioner through a Merck pregnancy registry regarding a 16 year old female who on 07-DEC-2006 was vaccinated IM with the first dose of Gardasil (Lot# not reported). On 08-DEC-2006 the patient had a positive pregnancy test result (test not specified). Unspecified medical attention was sought. At the time of this report no symptoms were reported and the outcome of the event was unknown. Follow up information was received from the nurse practitioner which stated that on an unspecified date the patient experienced a miscarriage at 13 weeks. Upon internal medical review the spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 290872   Vaccination Date: 2007-02-02
Age: 26.0   Onset Date: 2007-03-06   Days later: 32
Gender: Female   Submitted: 2007-09-18
State: Unknown   Entered: 2007-09-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/6/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0709USA01893
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse, via a company representative, concerning a 26 year old female patient, who on 11-DEC-2006, was vaccinated with the first dose of Gardasil, and on 02-FEB-2007 with the second dose of Gardasil (lot # not provided). On approximately 06-MAR-2007 ("on or about 06-MAR-2007") the patient became pregnant. On approximately 26-JUN-2007 ("approximately 16 weeks later"), she had a miscarriage. At the time of this report, the outcome of "had a miscarriage" was unknown. Upon internal review, "had a miscarriage" was determined to be serious as an other important medical event. Additional information has been requested.

 

VAERS ID: 291285   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-09-24
State: Unknown   Entered: 2007-09-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0709USA02009
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received through a Merck Pregnancy registry from an office manager concerning a female (age not reported) who on an unspecified date was vaccinated with a second dose of Gardasil. It was reported that the patient had a miscarriage after being vaccinated with a second dose of Gardasil. Upon internal review, the patient's miscarriage was considered an other important medical event. Additional information has been requested.
VAERS ID: 291686   Vaccination Date: 2007-05-31
Age: 17.0   Onset Date: 2007-06-06   Days later: 6
Gender: Female   Submitted: 2007-09-28
State: Wyoming   Entered: 2007-10-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = unknown)
Diagnostic Lab Data: serum beta-human
Previous Vaccinations:
Other Medications: antimicrobial (unspecified); hormonal contraceptives
Preexisting Conditions:
CDC 'Split Type': WAES0709USA03460
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Write-up: Information has been received from Merck Pregnancy Registry for the Gardasil vaccine from a health professional concerning a 17 year old female patient who on 31-MAY-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and antimicrobial (unspecified). The reporter reported that patient miscarried on 18-AUG-2007 after receiving the dose of Gardasil. The estimated date of conception was about 06-JUN-2007. On an unspecified day laboratory test serum beta-human chorionic gonadotropin test was done. Unspecified medical attention was sought. The outcome was unknown. Upon internal review, miscarried was considered an other important medical event. Additional information has been requested.
VAERS ID: 292471   Vaccination Date: 2007-07-24
Age: 24.0   Onset Date: 2007-07-24   Days later: 0
Gender: Female   Submitted: 2007-10-08
State: North Carolina   Entered: 2007-10-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=6/24/2007), Drug hypersensitivity
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0710USA00945
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage
Write-up: Information has been received via the Merck Pregnancy registry, from a registered nurse, a 24 year old female with a drug hypersensitivity to morphine, who was unknowingly pregnant (LMP date of 24-JUN-2007) when on 24-JUL-2007 she was vaccinated with the first dose of Gardasil (lot # not provided). On 17-SEP-2007 the nurse reported that she "started to miscarry," and consequently underwent an outpatient dilation & curettage (D & C) procedure. The fetus was at 8 weeks gestation at the time of the miscarriage. At the time of this report, the patient had recovered (duration not specified). The nurse considered miscarriage to be serious as an other important medical event. Additional information has been requested.
VAERS ID: 293081   Vaccination Date: 2007-05-30
Age: 14.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-10-12
State: Unknown   Entered: 2007-10-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0710USA00779
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0960F 0 UN UN
MNQ SANOFI PASTEUR     UN UN
TTOX UNKNOWN MANUFACTURER     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician through the Merck Pregnancy Registry concerning a 14 year old female who on 30-MAY-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (lot # 654535/0960F). Concomitant therapy on 30-MAY-2007 included Menactra and tetanus toxoid. A second 0.5 ml IM dose of Gardasil (lot # 654535/0960F). Subsequently the patient had a miscarriage at 9 weeks. Upon internal review, miscarriage was considered an other important medical event. Additional information has been requested.
VAERS ID: 293269   Vaccination Date: 2007-03-29
Age: 33.0   Onset Date: 2007-04-01   Days later: 3
Gender: Female   Submitted: 2007-10-15
State: Unknown   Entered: 2007-10-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0710USA02359
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Uterine dilation and curettage
Write-up: Information has been received for pregnancy Registry for Gardasil from a Certified Medical Assistant (C.M.A) concerning a 33 year old female patient who on 29-MAR-2007 was vaccinated with a first dose of Gardasil and on 26-APR-2007, received her second dose of Gardasil. The patient was discovered to be pregnant in July (date unspecified). In August there was no fetal heartbeat detected (date unspecified). The patient had a Dialation and curettage (D & C) on 18-SEP-2007 and post D & C visit on 04-OCT-2007. It was unclear if any fetal tissue was recovered and what the cause of the termination of pregnancy. No other information to report. On 04-OCT-2007 patient recovered. Upon internal review, miscarriage was determined other medical event (OME) category. Additional information has been requested.
VAERS ID: 293566   Vaccination Date: 2007-08-14
Age:    Onset Date: 2007-08-14   Days later: 0
Gender: Female   Submitted: 2007-10-17
State: Unknown   Entered: 2007-10-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0710USA02985
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received via the Merck Pregnancy registry from a consumer, concerning her daughter (age not specified) who was pregnant when vaccinated on 14-AUG-2007, with a dose of Gardasil (lot # not specified). The mother stated that "the fetus had no heartbeat," and indicated that her daughter had a miscarriage (date not provided). At the time of this report, the outcome of miscarriage was unknown. The consumer's daughter sought unspecified medical attention from her physician. Additional information has been requested.
VAERS ID: 293739   Vaccination Date: 2007-04-01
Age: 25.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-10-18
State: Unknown   Entered: 2007-10-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 7/9/2007)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0708USA04042
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Initial and follow-up information has been received through the Merck pregnancy registry from a 25 year old female, who in approximately April 2007, was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient became pregnant. The patient's last menstrual period was 09-Jul-2007, with an estimated date of delivery was 14-Apr-2008. Subsequently, on an unspecified date, the patient had a miscarriage at 10 weeks. Upon internal review, miscarriage was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 293740   Vaccination Date: 2007-04-24
Age: 25.0   Onset Date: 2007-09-20   Days later: 149
Gender: Female   Submitted: 2007-10-18
State: Delaware   Entered: 2007-10-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 7/7/2007) Headache; Depression
Diagnostic Lab Data: ultrasound 09/17/07 - bleeding-fetal demise
Previous Vaccinations:
Other Medications: CELEXA; FLEXERIL
Preexisting Conditions:
CDC 'Split Type': WAES0708USA01727
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Ultrasound scan abnormal
Write-up: Initial and follow-up information has been received from a 25 year old female with headaches, depression, and no drug allergies, who on 23-FEB-2007 and 24-APR-2007 was vaccinated with a first dose and second dose of Gardasil, respectively. Concomitant medication included citalopram hydrobromide (CELEXA) and cyclobenzaprine hydrochloride (MSD). Subsequently, after receiving the first two vaccinations the patient reported she was 5 weeks pregnant. It was noted that the patient discontinued the dosing schedule. The patient's last menstrual period was 07-JUL-2007, the estimated conception date was approximately 21-JUL-2007, and the estimated delivery date was approximately 14-APR-2007. On 17-SEP-2007 the patient had an ultrasound due to bleeding and the results of the test were reported as fetal demise. On 20-SEP-2007 the patient had a spontaneous abortion at 10 weeks. The products of conception were examined and reported as immature chorionic villi with decidua. It was unknown if the fetus was normal. The patient did not have any previous pregnancies. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
VAERS ID: 294096   Vaccination Date: 2007-04-25
Age: 17.0   Onset Date: 2007-04-25   Days later: 0
Gender: Female   Submitted: 2007-10-22
State: Michigan   Entered: 2007-10-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/27/2007)
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0705USA00693
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received through the Merck pregnancy registry and from a mother of a 17 year old female patient who on 25-APR-2007 was vaccinated IM with a second 0.5ml dose of Gardasil (date unknown of first injection). On 25-APR-2007, the patient discovered she was pregnant. (date of LMP = 27-MAr-2007). Follow up information stated that on approximately 13-MAY-2007, the patient had a spontaneous abortion. She was approximately 7 weeks from her LMP. It was unknown if the products of conception were examined or if the fetus was normal. At the time of this report, the patient's outcome was unknown. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 294377   Vaccination Date: 2007-09-14
Age: 18.0   Onset Date: 2007-06-11   Days later: -95
Gender: Female   Submitted: 2007-10-24
State: Texas   Entered: 2007-10-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 8/14/2007); Drug hypersensitivity
Diagnostic Lab Data: ultrasound 09/17/07 - 4w/6d sac; beta-human chorionic 09/14/07 - positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0709USA02456
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1447f 2 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test positive, Ultrasound scan
Write-up: Information has been received from the Merck Pregnancy Registry via a physician concerning an 18 year old female with no previous pregnancies and a drug hypersensitivity to codeine who 28-FEB-2007 was vaccinated with a first dose of Gardasil (lot #655617/1447F). On 11-JUN-2007, the patient was vaccinated with a second dose of Gardasil (lot #655617/1447F). On 14-SEP-2007, the patient was vaccinated IM with a third 0.5 ml dose of Gardasil (lot #655617/1447F). There was no concomitant medication. On 14-SEP-2007, the patient had a positive pregnancy test. The patient's last menstrual period was 14-AUG-2007 and the estimated date of delivery was 20-MAY-2008. On 17-SEP-2007 and ultrasound revealed the patient was 4 weeks and 6 days with sac. On 03-OCT-2007, the patient had a spontaneous abortion. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested.

 

VAERS ID: 294379   Vaccination Date: 2007-05-29
Age:    Onset Date: 2007-06-01   Days later: 3
Gender: Female   Submitted: 2007-10-24
State: Colorado   Entered: 2007-10-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: beta-human chorionic 06/01/07 posit
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0710USA03992
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a Merck pregnancy registry from a nurse concerning herself. She reported that on 21-APR-2007 she was vaccinated IM with the first dose of Gardasil (Lot#0641B). On 29-MAY-2007 she received the second dose of Gardasil (Lot# not provided). On 01-JUN-2007 she learned she was four weeks pregnant and experienced viral vaccine exposure during pregnancy. On 28-JUN-2007 the patient experienced a miscarriage and was hospitalized. Unspecified medical attention was sought. Subsequently, the patient recovered from the miscarriage. Upon internal medical review the spontaneous abortion was considered an other medical event. Additional information has been requested.
VAERS ID: 294546   Vaccination Date: 2007-08-06
Age: 19.0   Onset Date: 2007-08-06   Days later: 0
Gender: Female   Submitted: 2007-10-25
State: Unknown   Entered: 2007-10-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 7/14/2007) Contraception
Diagnostic Lab Data: Ultrasound 09/04/07 - fetus less than five weeks; urine beta-human 09/04/07 +; Pap test ?/?/05 - abnormal; serum alpha-human 09/10/07 4379; Pap test ?/?/06 - abnormal; Pap test ?/?/07 - abnormal
Previous Vaccinations:
Other Medications: NUVARING
Preexisting Conditions: Cervical intraepithelial neoplasia; Loop electrosurgical excision procedure
CDC 'Split Type': WAES0709USA00258
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0212U 2 IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Smear cervix abnormal, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Write-up: Initial and follow-up information has been received from a health professional concerning a 19 year old female with no known allergies and a history of cervical intraepithelial neoplasia and loop electrosurgical excision procedures in May 2005, April 2006, and April 2007, who on 03-APR-2007 was vaccinated with the second dose of Gardasil (Lot #0212U). On 06-AUG-2007, the patient was vaccinated with the third dose of Gardasil (Lot #0212U). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). Prior to the third vaccination, the patient's method of birth control, ethinyl estradiol (+) etonogestrel had been discontinued and the patient was going to change to drospirenone (+) ethinyl estradiol (YAZ). The patient was instructed to take precautionary measures until that was started. On 04-SEP-2007, the patient was seen in the clinic and tested positive for pregnancy. An internal exam was performed and a urine pregnancy test was positive. An ultrasound showed that that fetus was less than five weeks. On 10-SEP-2007, a serum HCG was 4379. The patient's estimated was approximately 14-JUL-2007 (previously reported as 23-JUL-2007); estimated EDC 28-APR-2008. Follow-up information indicated that the patient had a spontaneous abortion (miscarriage) on 13-OCT-2007. Additional information has been requested.
VAERS ID: 294984   Vaccination Date: 2007-07-05
Age:    Onset Date: 2007-10-23   Days later: 110
Gender: Female   Submitted: 2007-10-30
State: Washington   Entered: 2007-10-31
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: total serum human ?/?/07 - pregnant; complete blood cell ?/?/07; erythrocyte ABO antigen ?/?/07; erythrocyte Rh antigen ?/?/07
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen Lo
Preexisting Conditions:
CDC 'Split Type': WAES0710USA05709
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Full blood count, Pregnancy test positive, Red blood cell scan
Write-up: Information has been received via the Merck Pregnancy registry, from a registered nurse, concerning a female patient (age not specified) who on 05-JUL-2007 was vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included ethinyl estradiol/noregestimate (ORTHO TRI-CYCLEN LO). On an unknown date, the patient became pregnant (gestation details not provided), and on 23-OCT-2007 she had miscarriage. She was treated in the physician's office (details not provided). At the time of this report, the patient was recovering from the miscarriage. Upon internal review, the event of miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 295177   Vaccination Date: 2007-09-10
Age: 22.0   Onset Date: 2007-10-08   Days later: 28
Gender: Female   Submitted: 2007-10-31
State: Kansas   Entered: 2007-11-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 08/27/2007); Papilloma viral infection; Depression
Diagnostic Lab Data: beta-human chorionic 10/08/07 - positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0710USA04863
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1060U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse concerning a 22 year old female with papilloma viral infection, depression, and no drug allergies, who on 10-SEP-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 658556/1060U). There was no concomitant medication. Subsequently, the patient believed that she had become pregnant on the same day as the vaccination. On 08-OCT-2007 a pregnancy test was performed and was positive. The patient's last menstrual period was 27-AUG-2007 and her estimated delivery date was 02-JUN-2008. On 20-OCT-2007 the patient had a miscarriage. No other symptoms were noted. The patient had an office visit. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 295850   Vaccination Date: 2007-09-06
Age: 21.0   Onset Date: 2007-10-09   Days later: 33
Gender: Female   Submitted: 2007-11-02
State: Texas   Entered: 2007-11-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: According to the subject, an ultrasound (date not reported) revealed she experienced a spontaneous abortion about five weeks gestation. 10 October 2007: Ultrasound, results pending at the time of this report.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Negative pregnancy test at screening for study on 23 August 2007, and again on study entry 06 September 2007. The subject has a past medical history of HIV infection, and tubal pregnancy loss.
CDC 'Split Type': 200703659
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ SANOFI PASTEUR   0 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Stress, Ultrasound scan abnormal
Write-up: Initial report received on 26 October 2007. The following is verbatim from that report. "Summary: The subject is a 21 year-old, HIV infected, female, enrolled on September 6, 2007 in a study, who experienced grade 2 miscarriage on October 9, 2007. The subject had negative pregnancy tests at study screening on August 23, 2007 and at study entry on September 6, 2007. She also admitted to using birth control as required in the eligibility criteria. On September 2007, the subject received one single dose of the study agent, Quadrivalent Meningococcal Conjugated vaccine. On study day 33, the subject informed the site that she had spontaneous abortion of a 5 weeks gestation. She reported going through some stress condition before the abortion, because her 2 year-old child was hospitalized for trauma a day before she experienced excessive bleeding. She further stated that, prior to the study entry; she had a past history of tubal pregnancy loss. On October 10, 2007, the subject had an abdominal ultrasound done, the report of which was still pending, as at the time of this report." "Assessment of Relationship: The site Principal Investigator has assessed the event of miscarriage as probably not related to the study agent, Quadrivalent Meningococcal Conjugate vaccine. The DAIDS Medical Officer has assessed the event of miscarriage as probably not related to, but could not rule out the relationship to the study agent, Quadrivalent Meningococcal Conjugate vaccine. After review of the clinical details and investigator comments pertaining to the adverse event, and based upon our experience with this agent, the Division of AIDS does not believe that changes to the conduct of this trial are warranted." "Previous Reports: There has been no similar safety reports previously submitted for this IND." "Patient History and Clinical Evaluation: Clinical Evaluation: The subject is a 21 year-old, HIV infected, female, enrolled on September 6, 2007 in a study, who experienced grade 2 miscarriage on October 9, 2007. The subject had negati
VAERS ID: 296427   Vaccination Date: 0000-00-00
Age: 16.0   Onset Date: 2007-05-25   Days later:
Gender: Female   Submitted: 2007-11-09
State: Arkansas   Entered: 2007-11-12
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Penicillin allergy
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0711USA00909
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a 16 year old female consumer with no previous medical history, and an allergy to penicillin, who was vaccinated at an unknown date, with the first dose of Gardasil. There was no concomitant medication. The patient reported that she did not know that she was one week pregnant at the time of vaccination. On 25-May-2007 she found out that she was pregnant. It was reported that on 25-Jul-2007 the patient had a miscarriage. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. Upon internal review miscarriage considered to be an other important medical event. Additional information has been requested.
VAERS ID: 296619   Vaccination Date: 0000-00-00
Age: 17.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-11-13
State: Unknown   Entered: 2007-11-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0711USA01459
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician's assistant concerning a 17 year old female who, on an unspecified date, was vaccinated with Gardasil. Three weeks after the vaccination, the patient experienced a miscarriage. The patient was not known to be pregnant at the time the vaccine was administered. The patient was examined in a local emergency room, but no details are available. The patient was examined in the office as follow-up, but no details were provided. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 297527   Vaccination Date: 2007-02-01
Age: 19.0   Onset Date: 2007-04-01   Days later: 59
Gender: Female   Submitted: 2007-11-20
State: New Jersey   Entered: 2007-11-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: diagnostic laboratory
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0706USA02481
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Intra-uterine death, Laboratory test
Write-up: Information has been received through the Merck pregnancy registry, from a physician, concerning a 19 year old female who in March 2007, was vaccinated with a second dose of Gardasil. Subsequently the patient received her two doses of the vaccine and then became pregnant. Unspecified medical attention was sought. Follow up information received from the mother of the patient, indicated that in September 2006, her daughter received the first dose of Gardasil, on an unknown date the second dose, and in February 2007 the third dose of Gardasil (lot #'s not provided). She reported her daughter became pregnant in April 2007. In November, when 7 months pregnant, her daughter was admitted to the hospital for abdominal pain, and on 04-NOV-2007, she "lost her baby." The child "had no heartbeat and was dead for a week in her womb. The child was not fully formed." She added that the fetus's eyes, ears and nose were not fully developed. Her daughter remained in the hospital for "about a week." At the time of this report, she was recovering from the event. Additional information has been requested.
VAERS ID: 298449   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-11-30
State: New York   Entered: 2007-12-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0711USA04825
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received as part of a pregnancy registry from a physician concerning a female who was vaccinated with Gardasil. As of 26-NOV-2007, the patient "recently" miscarried. Upon interval review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 298451   Vaccination Date: 2007-10-20
Age: 22.0   Onset Date: 2007-10-20   Days later: 0
Gender: Female   Submitted: 2007-11-30
State: Unknown   Entered: 2007-12-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: Zoloft, Ambien
Preexisting Conditions:
CDC 'Split Type': WAES0711USA04956
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received through the pregnancy registry through a 22 year old female who on 20-OCT-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included sertraline HCl (ZOLOFT) and zolpidem tartrate (AMBIEN). On approximately 27-OCT-2007 the patient found out she was pregnant (not further specified). On approximately 24-NOV-2007 the patient experienced a miscarriage. The patient sought unspecified medical attention with a physician. Upon internal review, miscarriage was determined to be an other important medical event. No additional information is expected.

 

VAERS ID: 298810   Vaccination Date: 2007-07-24
Age: 17.0   Onset Date: 2007-09-20   Days later: 58
Gender: Female   Submitted: 2007-12-04
State: Unknown   Entered: 2007-12-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown) Anaemia; Vaginitis trichomonal
Diagnostic Lab Data: ultrasound 09/24/07 reason-bleeding result-empty gestational sac vs. an embryonic pregnancy implying early spontanoeus, urine beta-human
Previous Vaccinations:
Other Medications: ferrous sulfate 325 mg; metronidazole 500 mg; metronidazole 500 mg; vitamins (unspecified)
Preexisting Conditions: Termination of pregnancy-elective
CDC 'Split Type': WAES0709USA03260
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0525U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Anaemia, Blighted ovum, Drug exposure during pregnancy, Haemorrhage, Ultrasound uterus, Urine human chorionic gonadotropin positive
Write-up: Initial and follow-up information has been received from a nurse practitioner through the pregnancy registry concerning a 17 year old female with a history of an elective termination of a previous pregnancy, and with borderline anaemia, Trichomonas, and no drug allergies, who on 24-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included vitamins (unspecified), ferrous sulfate, and metronidazole. Subsequently, the patient was determined to be pregnant. No problems were reported. The patient's last menstrual period was reported as the end of June 2007. The patient was examined in the office. On 20-SEP-2007 the patient had a spontaneous abortion approximately "10 to 12 weeks" from the last menstrual period. The methods of conception were not examined. During the pregnancy the patient had Trichomonas which was treated with metronidazole 500mg, two times a day for 7 days. The treatment was started on 24-JUL-2007 and 20-SEP-2007. On 24-SEP-2007 an ultrasound was performed due to bleeding and the results showed empty gestational sac versus an embryonic pregnancy implying that an early spontaneous abortion was in progress. The patient had one previous pregnancy that resulted in an elective termination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 299243   Vaccination Date: 2007-03-27
Age: 18.0   Onset Date: 2007-05-01   Days later: 35
Gender: Female   Submitted: 2007-12-10
State: Nebraska   Entered: 2007-12-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: urine beta-human 05/25/07 posit; serum beta-human posit
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: Sulfonamide allergy
CDC 'Split Type': WAES0712USA01216
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0188U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received through the Merck pregnancy registry through a laboratory technician concerning a 19 year old female with a history of sulfonamide allergy (BACTRIM) who on 27-MAR-2007 was vaccinated with the first 0.5 ml dose of Gardasil (Lot # 657006/0188U). There was no concomitant medication. It was reported that on 25-MAY-2007 the patient got a positive pregnancy test through urine HCG test and had a miscarriage on 31-MAY-2007. The patient recovered around the end of May from the miscarriage. The patient did not report any adverse reaction. The patient completed the Gardasil series and received the second dose on 19-Jul-2007 and the third dose on 09-Nov-2007. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested.
VAERS ID: 299547   Vaccination Date: 0000-00-00
Age: 28.0   Onset Date: 2007-11-10   Days later:
Gender: Female   Submitted: 2007-12-13
State: North Carolina   Entered: 2007-12-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107.
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': A0698182A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU GLAXOSMITHKLINE BIOLOGICALS     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Metrorrhagia, Muscle spasms, Ultrasound abdomen, Vaginal haemorrhage
Write-up: This case was reported by a consumer and described the occurrence of spontaneous abortion in a 28-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). On 10 November 2007, at an unspecified time after vaccination with Flu vaccine, the subject experienced cramping and light vaginal spotting. An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107. Heavy bleeding and passing of material began on 17 November 2007, concluding on 23 November 2007. The reporter referred to the events collectively as a spontaneous abortion beginning on 17 November 2007. This case was assessed as medically serious by manufacturer. The spontaneous abortion with heavy bleeding and passing of material resolved by 23 November 2007. Outcome of other reported symptoms was unspecified.
VAERS ID: 300370   Vaccination Date: 2007-10-04
Age: 16.0   Onset Date: 2007-11-07   Days later: 34
Gender: Female   Submitted: 2007-12-18
State: Michigan   Entered: 2007-12-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 09/15/5007); Asthma
Diagnostic Lab Data: beta-human chorionic 10/11/07 - positive
Previous Vaccinations:
Other Medications: Ventilan (albuterol)
Preexisting Conditions:
CDC 'Split Type': WAES0710USA06218
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a physician concerning a 16 year old female with asthma who on 02-AUG-2007 was vaccinated intramuscularly with her first dose of Gardasil. On 04-OCT-2007 she received her second dose of Gardasil intramuscularly. Concomitant therapy included VENTILAN. The patient was determined to be pregnant on 11-Oct-2007 with a pregnancy test. The patient sought unspecified medical attention in the office. Subsequently the patient experienced vaccine exposure during pregnancy. No problems reported. No further details available. Additional information has been requested. Follow up information received on 11-Dec-2007 from the physician stated that the patient had a spontaneous abortion on 07-Nov-2007, approximately 8 weeks from LMP. The products of conception were examined and described as hemorrhagic necrotic dicidua few syncytiotrophoblastic cells involutengehorioric villi.
VAERS ID: 300380   Vaccination Date: 0000-00-00
Age: 20.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-12-18
State: Unknown   Entered: 2007-12-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0712USA06468
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Herpes zoster
Write-up: Information has been received from a health professional concerning a female employee in her 20's, with no history of shingles, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006. It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck). Subsequently the patient was diagnosed with shingles by her physician and treated. It was noted that the patient had shingles twice and suffered a miscarriage. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's miscarriage was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
VAERS ID: 300551   Vaccination Date: 2007-08-01
Age: 19.0   Onset Date: 2007-08-13   Days later: 12
Gender: Female   Submitted: 2007-12-19
State: New Jersey   Entered: 2007-12-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 8/13/2007); Penicillin allergy; Smoker
Diagnostic Lab Data: ultrasound 10/23/07 empty sac; elevated beta; ultrasound 10/30/07 elevated beta;empty sac; serum beta-human positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0709USA04214
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0469U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan abnormal
Write-up: Information has been received through the pregnancy registry through a nurse concerning a 19 year old female with a history of social smoking, penicillin allergy, and with two previous pregnancies (two elective abortions) who on 01-AUG-2007 was vaccinated intramuscularly with her first dose of Gardasil (Lot # 0469U). There was no concomitant medication. The patient had a blood pregnancy test (date unspecified) which was positive (LMP=13-AUG-2007). The patient sought unspecified medical attention in the office. No symptoms were reported. On 23-OCT-2007 and 30-OCT-2007, the patient had an ultrasound due to elevated beta levels. The ultrasounds showed an empty sac. The reporter indicated that there was a question as to whether there was missed antibodies vs. an ectopic pregnancy, but it was probably missed antibodies. On an unspecified date, the patient had a spontaneous abortion, no further details were provided. Additional information has been requested.
VAERS ID: 300880   Vaccination Date: 2007-09-10
Age: 37.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-12-19
State: Massachusetts   Entered: 2007-12-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: 26 October 2007 - An ultrasound showed no fetal heartbeat.
Previous Vaccinations:
Other Medications: prenatal vitamins, calcium
Preexisting Conditions: Allergy to Penicillin; two prior pregnancies with full-term, normal deliveries. Follow-up information received on 14 December 2007 noted that the patient's medical history included high blood pressure at the end of her first pregnancy, as well as post-partum thyroid dysfunction. She had upper respiratory infection/cold from 10 September 2007 to 17 September 2007 and again from 15 O
CDC 'Split Type': 200703386
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal heart rate abnormal, Nasopharyngitis, Ultrasound scan abnormal, Upper respiratory tract infection
Write-up: Seriousness criteria: other - medically significant. This case was reported by a health professional on 05 October 2007. A 37-year-old female patient, with an allergy to penicillin, received an intramuscular injection of Adacel on 10 September 2007. The patient, who was also a physician, had received a tetanus vaccine (manufacturer and lot number unknown) in January 2007. She was pregnant at the time of vaccination, and the date of her last menstrual period was 23 August 2007. Obstetric history included two previous pregnancies with normal, full-term deliveries. An ultrasound on 02 October 2007 confirmed the pregnancy, and estimated date of delivery was 29 May 2008. Concomitant medication included prenatal vitamins. The patient experienced no adverse reactions. Follow-up information was received on 14 December 2007, case reference number 0711091401. It was reported that an ultrasound on 26 October 2007 showed no fetal heartbeat. The patient had a miscarriage. No further information regarding the event or the outcome is available. The patient's medical history included high blood pressure at the end of her first pregnancy, as well as post-partum thyroid dysfunction. She had an upper respiratory infection/cold from 10 September 2007 to 17 September 2007 and again from 15 October 2007 to 15 October 2007. She had exposure to alcohol (wine, eight to ten drinks total) in September 2007 and caffeine (coffee, one to two cups per day) during August 2007 and September 2007. Based upon the new information regarding the event of miscarriage, this case has been upgraded to serious.
VAERS ID: 300961   Vaccination Date: 2007-10-18
Age: 13.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-12-26
State: Illinois   Entered: 2007-12-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NA
Diagnostic Lab Data: Not Any
Previous Vaccinations:
Other Medications: NA
Preexisting Conditions: NA
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0245U 0 IM RA
MNQ SANOFI PASTEUR U2226AA 0 IM RA
TDAP GLAXOSMITHKLINE BIOLOGICALS AC52B016BA 0 IM LA
Administered by: Public     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Pt stated that she was pregnant at the time of her last set of immunizations but had not realized it at the time. She stated after receiving the vaccines, she took a pregnancy test and learned she was "a few weeks pregnant." She reported that she had then miscarried at 9 weeks.
VAERS ID: 301242   Vaccination Date: 2007-08-22
Age: 24.0   Onset Date: 2007-11-05   Days later: 75
Gender: Female   Submitted: 2007-12-28
State: Unknown   Entered: 2007-12-31
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=7/7/2007) Asthma; Hypoglycaemia
Diagnostic Lab Data: beta-human chorionic
Previous Vaccinations:
Other Medications: albuterol
Preexisting Conditions: Cervical cancer; Smoker
CDC 'Split Type': WAES0709USA04280
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0384U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy
Write-up: Initial and follow-up information has been received from a registered nurse through the Pregnancy registry concerning a 24 year old female smoker of 1/2 pack per day who quit on 25-SEP-2007, with a history of cervical cancer in 2001, and with asthma, hypoglycemia diagnosed in April 2005, and no drug allergies, who on 22-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (Lot# 657617/0384U). Concomitant therapy included albuterol inhaler. Subsequently, the patient was pregnant. The patient's last menstrual period was 04-JUL-2007 and her estimated delivery date was 23-APR-2008. The patient had an office visit. A pregnancy test was performed (no results provided). At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up indicated that on 05-NOV-2007 the patient had a spontaneous abortion 16 weeks from her last menstrual period. It was unknown if the products of conception were examined. It was reported that the patient had not seen a doctor for this pregnancy. The patient was seen in the emergency room on 05-NOV-2007 when she learned of the miscarriage. The patient had 3 previous pregnancies with 1 full term delivery, 1 spontaneous abortion, and 1 elective termination. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 301726   Vaccination Date: 2007-10-20
Age: 18.0   Onset Date: 2007-10-20   Days later: 0
Gender: Female   Submitted: 2008-01-03
State: Unknown   Entered: 2008-01-04
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 10/5/2007)
Diagnostic Lab Data: ultrasound, 12/14/07, did not detect a fetal heartbeat; ultrasound, 12/17/07, did not detect a fetal heartbeat; beta-human chorionic, 10?/??/07, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0712USA08672
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal heart rate abnormal, Pregnancy test positive, Ultrasound scan abnormal
Write-up: Information has been received from an RN concerning an 18 year old female patient who had delivered her first child in January 2007 who on 20-OCT-2007 was vaccinated IM with a a first dose of Gardasil. Within 2 weeks she had a positive pregnancy test at another facility. Her LMP was 05-OCT-2007. Sonagrams on 14-DEC-2007 and 17-DEC-2007 did not detect a fetal heartbeat. It was reported that she "later" miscarried. Medical attention was sought in the office. Her outcome was not reported. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.

 

VAERS ID: 301933   Vaccination Date: 2007-12-02
Age: 21.0   Onset Date: 2007-12-07   Days later: 5
Gender: Female   Submitted: 2008-01-07
State: Texas   Entered: 2008-01-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown); Migraine
Diagnostic Lab Data: Beta-human chorionic - positive
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0712USA07866
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER     UN UN
HPV4 MERCK & CO. INC.   0 UN UN
TTOX UNKNOWN MANUFACTURER     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Write-up: Information has been received from a 21 year old female with a history of severe migraines, who on 02-DEC-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (unspecified) and tetanus toxoid. On 07-DEC-2007, five days after the vaccination the patient found out that she was pregnant. Medical attention was sought. The patient's outcome was not recovered. No product quality complaint was involved. Follow up information received on 31-DEC-2007 from the patient indicated that she had a miscarriage on 22-Dec-2007. No additional information provided. Upon internal review miscarriage considered to be an other important medical event. Additional information has been requested.
VAERS ID: 302710   Vaccination Date: 2007-08-02
Age: 18.0   Onset Date: 2007-08-02   Days later: 0
Gender: Female   Submitted: 2008-01-14
State: Washington   Entered: 2008-01-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown); Penicillin allergy; Hypersensitivity; Seasonal allergy
Diagnostic Lab Data: beta-human chorionic 10/01/07 posit
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0801USA00401
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP UNKNOWN MANUFACTURER     UN UN
HPV4 MERCK & CO. INC. 0171U 0 IM UN
VARCEL MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood gonadotrophin decreased, Drug exposure during pregnancy, Pregnancy test positive, Vaginal haemorrhage
Write-up: Information has been received from a nurse concerning an 18 year old female with no pertinent medical history, seasonal allergies and allergies to nickel and penicillin who on 02-AUG-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of the 0.5 ml Gardasil (lot#655620/0171U). The patient was concomitantly vaccinated with Varivax (MSD) and DTaP (manufacturer unknown). On 15-AUG-2007, the patient was seen in the emergency room with lowering hcg levels and some vaginal bleeding. On 16-AUG-2007 and 17-AUG-2007, the patient returned to the emergency room with continuing decreasing hcg levels and later had a spontaneous abortion (exact date not reported). On 01-OCT-2007, the patient was vaccinated intramuscularly (site not reported) with the 2nd dose of the 0.5 ml Gardasil (lot#658094/0524U) while pregnant (WAES#0801USA01237). Follow-up information was received from the nurse stating that the exact date of the spontaneous abortion and LMP after the 2nd dose of the Gardasil vaccine is unknown. Upon internal review spontaneous abortion was considered to be an other important medical events. Additional information has been requested.
VAERS ID: 303008   Vaccination Date: 2007-10-01
Age: 17.0   Onset Date: 2007-10-01   Days later: 0
Gender: Female   Submitted: 2008-01-17
State: California   Entered: 2008-01-18
Life Threatening Illness? No
Died? No
Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? Yes
Current Illness: Pregnancy NOS (LMP=Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0801USA02992
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Emotional distress
Write-up: Information has been received via the Merck pregnancy registry, from a physician, concerning a 17 year old female patient who was 2-3 weeks pregnant in October 2007, when she was vaccinated with the first dose of Gardasil (lot # not reported). On 13-JAN-2008, the patient had a miscarriage and was hospitalized (details and dates not provided). The physician stated that the patient was "traumatized." At the time of this report, the outcome of miscarriage and patient traumatized was unknown. The physician considered the miscarriage to be disabling/incapacitating due to the patient being traumatized. Additional information has been requested.
VAERS ID: 303186   Vaccination Date: 2007-07-01
Age: 26.0   Onset Date: 2007-07-01   Days later: 0
Gender: Female   Submitted: 2008-01-18
State: North Dakota   Entered: 2008-01-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=8/12/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0709USA04666
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Military     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage
Write-up: Information has been received from a 26 year old female with no pertinent medical history who in approximately July 2007, was vaccinated with her first dose of Gardasil. There was no concomitant medication. The patient called to join the Merck pregnancy registry. It was reported that the patient became pregnant around the same time she received her first vaccination. The patient last menstrual period was approximately 10-JUN-2007 and estimated delivery was 16-MAR-2008. In Jul-2007, the patient experienced no adverse effect. Unspecified medical attention was sought. Information was received on 04-JAN-2008 indicating the patient had a spontaneous abortion on 09-NOV-2007 (approximately 12 weeks from LMP, reported in follow up as 12-AUG-2007). The patient had a D&C on 09-NOV-2007. The pathology result was "consistent with product of conception." The spontaneous abortion was considered to be an other important medical event. No further information available.
VAERS ID: 303221   Vaccination Date: 2007-11-14
Age: 28.0   Onset Date: 2008-01-08   Days later: 55
Gender: Female   Submitted: 2008-01-23
State: Unknown   Entered: 2008-01-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: No other medications
Preexisting Conditions:
CDC 'Split Type': MA20080051
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU NOVARTIS VACCINES AND DIAGNOSTICS     IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: We received on 16 JAN 2008 via agency from a consumer the following information: A 28-year-old female patient, born on 22 JAN 1979, was vaccinated IM with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007. At 12-13 weeks gestational age caller discovered via ultrasound that she had miscarried on 08 JAN 2008. Company assessment: seriousness criterion: medically significant. Causality: insufficient date (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing). Expectedness assessment according to product information: Miscarriage is unexpected, drug exposure during pregnancy is expected after vaccination with Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. No.: NA08-00183.
VAERS ID: 303222   Vaccination Date: 2007-11-14
Age: 31.0   Onset Date: 2007-11-29   Days later: 15
Gender: Female   Submitted: 2008-01-23
State: Unknown   Entered: 2008-01-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: No other medications
Preexisting Conditions:
CDC 'Split Type': MA20080052
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU NOVARTIS VACCINES AND DIAGNOSTICS     IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: We received on 16 JAN 2008 via local agency, from a consumer the following information: Consumer left voice mail stating that she received vaccine in November. She wants to report an adverse event that she had her colleague (see case no. MA2008-0051) experienced. No additional information left with message. Addendum: On 16 JAN 2008 we received the following information: A 31-year-old female patient, born on 02 APR 1976 was vaccinated i.m. with 0.5 ml Fluvirin, batch no. unknown, on 14 NOV 2007. At 9 weeks gestational age caller discovered that she had miscarried on 29 NOV 2007. Company assessment: Seriousness criterion: medically significant. Causality: insufficient data (the amount of data is insufficient to finally assess causality as information about the pregnancy is missing). Expectedness assessment according to agency and local product information: Miscarriage is unexpected drug exposure during pregnancy is expected after vaccination with Fluvirin. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Local agency no.: NA08-00160
VAERS ID: 303299   Vaccination Date: 2007-09-07
Age: 17.0   Onset Date: 2007-09-28   Days later: 21
Gender: Female   Submitted: 2008-01-22
State: Unknown   Entered: 2008-01-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Penicillin allergy
Diagnostic Lab Data: computed axial - results not reported; magnetic resonance - results not reported; diagnostic laboratory - unspecified blood work - no results reported; electroencephalography - no results reported; computed axial - orbit and sinus - results
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: Fractured nose
CDC 'Split Type': WAES0801USA02870
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0930U 2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood test, Computerised tomogram, Drug exposure during pregnancy, Electroencephalogram, Haemorrhage, Headache, Laboratory test, Nuclear magnetic resonance imaging, Vertigo
Write-up: Information has been received from a nurse practitioner concerning an 18 female with a penicillin allergy and a history of a fractured nose. The nurse practitioner reported that the patient completed the Gardasil series and then miscarried. The patient received her first dose of Gardasil (Lot #655503/0012U) on 05-MAR-2007, her second dose on 05-MAY-2007 (Lot #657621/0387U) and her third dose on 07-SEP-2007 (Lot #658488/0930U). The patient miscarried 3-4 weeks after receiving the last dose approximately 28-SEP-2007. The mother of the patient said the miscarried fetus had developed for about 3 months. The patient went to the emergency room for the miscarriage and was treated there for bleeding post-miscarriage. The patient had also been treated at an unspecified OBGYN post-miscarriage for bleeding and presently vertigo and headaches. The patient has been to the emergency room twice for treatment post-miscarriage and an unspecified neurologist. It was unclear if the patient was ever hospitalized. There was no testing on the miscarried fetus, because it was "flushed" and not recovered. There was no other information to report. Upon internal review a miscarriage was considered an other important medical event. Additional information has been requested.
VAERS ID: 303839   Vaccination Date: 2007-05-01
Age: 17.0   Onset Date: 2007-05-01   Days later: 0
Gender: Female   Submitted: 2008-01-28
State: Unknown   Entered: 2008-01-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 10/22/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0801USA04453
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no drug reactions/allergies who in March 2007, was vaccinated with Gardasil (lot# unknown). There was no concomitant medication. In May 2007, the patient received her second dose of Gardasil (lot# unknown). The caller reported that on 30-JUL-2007 the patient experienced a miscarriage when she was 2 and 1/2 months pregnant. Caller was not aware as to when the patient learned about her pregnancy. Caller reported that the patient missed the third dose of Gardasil vaccine which was supposed to be given to her in "October 2007". The patient's LMP was approximately 22-OCT-2007 and is now 3 months pregnant again. The patient's estimated date of delivery is "July 2008". No further information was provided. Upon internal review miscarriage is considered to be an other medical event (OME). No further information is available.
VAERS ID: 303919   Vaccination Date: 0000-00-00
Age: 26.0   Onset Date: 2007-06-06   Days later:
Gender: Female   Submitted: 2008-01-29
State: New York   Entered: 2008-01-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: beta-human chorionic 06/06/07 - positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0706USA05104
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a 26 year old female who on 03-APR-2007 was vaccinated with a first dose of Gardasil (lot number unknown) IM. On 06-JUN-2007 the patient returned for a second dose of Gardasil and a beta-human chorionic gonadotropin test (unspecified) was conducted and the results were positive. The patient received her second dose of Gardasil. Patient returned on 26-JUN-2007 and received a second dose of Gardasil at that time and the patient was no longer pregnant. No further information was available. The date of the last menstrual period and the estimated time of delivery is unknown. Follow-up information was received. The patient had no pertinent medical history or drug reactions/allergies. The patient had a spontaneous abortion "4/07" from LMP. It was unknown if the products of conception were examined. The fetus was not normal. In May 2007 a diagnostic laboratory test was performed during pregnancy. No further information was available. Upon internal review spontaneous abortion was considered to be an other important medical event (OME). Additional information is not expected.
VAERS ID: 304331   Vaccination Date: 2007-09-25
Age: 24.0   Onset Date: 2007-10-12   Days later: 17
Gender: Female   Submitted: 2008-02-04
State: Unknown   Entered: 2008-02-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 10/12/2007)
Diagnostic Lab Data: diagnostic laboratory
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0801USA05321
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1267U 2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test
Write-up: Information has been received from a 24 year old female consumer who on 25-JUL-2007 was vaccinated with her first dose of Gardasil (Lot # 658490/0802U). On 25-SEP-2007, the patient was vaccinated with her second dose of Gardasil (Lot # 656050/0245U). On 25-Jan-2008, the patient was vaccinated with her third dose of Gardasil (Lot # 659439/1267U). There was no concomitant medication. On an unspecified date, the patient found out she was pregnant (LMP approximately 12-OCT-2007). The patient had unspecified blood work performed. On an unspecified date, the patient had to go to the emergency room where she was informed that she had a miscarriage. No additional information was provided. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.

 

VAERS ID: 304564   Vaccination Date: 2007-04-26
Age: 16.0   Onset Date: 2007-05-01   Days later: 5
Gender: Female   Submitted: 2008-02-07
State: Unknown   Entered: 2008-02-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown); Drug hypersensitivity; Penicillin allergy
Diagnostic Lab Data: Beta-Human Chorionic 05/01/07 positive
Previous Vaccinations:
Other Medications: Advair, Menactra
Preexisting Conditions: Asthma
CDC 'Split Type': WAES0705USA01148
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1426F   IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a nurse, for the Pregnancy Registry for Gardasil, concerning a 17 year old female with drug hypersensitivity and penicillin allergy and a history of asthma. on 26-APR-2007 the patient was vaccinated with Gardasil (Lot#655205/1426F). Concomitant therapy included ADVAIR and MENACTRA. On 01-MAY-2007 the patient's mother notified the office that her daughter tested positive to a home pregnancy test. It was reported that the patient sought unspecified medical attention. No further information is available at this time. Follow up information received from the pediatrician, indicated that the patient had a spontaneous abortion, on/or at less than 20 weeks of gestation (date not specified). The outcome of spontaneous abortion was not specified. No further details were provided. Upon internal review, spontaneous abortion was considered to be serious as an other important medical event. Additional information is not expected.
VAERS ID: 304736   Vaccination Date: 2007-08-01
Age: 21.0   Onset Date: 2007-08-01   Days later: 0
Gender: Female   Submitted: 2008-02-11
State: New Jersey   Entered: 2008-02-12
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = 8/25/2007); penicillin allergy
Diagnostic Lab Data: ultrasound - see narrative; beta-human chorionic 10/07/07 - positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0802USA00286
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Ultrasound scan abnormal
Write-up: Information has been received from a consumer concerning her 21 year old daughter with a history of penicillin allergy who in "the beginning of" August 2007, was vaccinated intramuscularly with her first dose of Gardasil. At "the end of" September 2007, the patient was vaccinated intramuscularly with her second dose of Gardasil. There was no concomitant medication. On 07-OCT-2007, the patient had a pregnancy test which was positive, and showed that she was 6 weeks pregnant. An ultrasound showed that the baby had no kidneys (not further specified). On 22-JAN-2008 the patient experienced a miscarriage and was hospitalized. The reporter also stated there may have been "fluid on the brain". Additional information has been requested.
VAERS ID: 304879   Vaccination Date: 2007-03-12
Age: 17.0   Onset Date: 2007-03-12   Days later: 0
Gender: Female   Submitted: 2008-02-13
State: Unknown   Entered: 2008-02-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 2/1/2007); Ovarian cyst
Diagnostic Lab Data: ultrasound 02/28/07 - revealed complex ovarian cyst; ultrasound 03/30/07 - determined that pt was 6 wks & 4 days pregnant; ultrasound 02/28/07 - confirmed pt not pregnant; urine beta-human 02/28/07 - confirmed pt not pregnant
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Abortion spontaneous; Pelvic inflammatory disease
CDC 'Split Type': WAES0802USA00792
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0014U 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound abdomen abnormal, Urinary tract infection, Urine human chorionic gonadotropin negative, Uterine dilation and curettage
Write-up: Information has been received from a physician's assistant concerning a 17 year old female who has had "multiple sexual partners and engages in high risk behavior". Her first pregnancy resulted in a spontaneous abortion in March 2006. On 06-FEB-2007, the patient had pelvic inflammatory disease from which she recovered. On 28-FEB-2007, the patient had an ultrasound which revealed a complex ovarian cyst. Also on 28-FEB-2007, urine and ultrasound tests confirmed that the patient was not pregnant. She was referred to a gynecologist for evaluation of her ovarian cyst. On 12-MAR-2007, the patient was vaccinated with the first dose of GARDASIL (lot #653736/0014U), 0.5 ml. On 30-MAR-2007, the patient presented to the gynecologist for evaluation of her existing ovarian cyst. It was determined via ultrasound that the patient was 6 weeks and 4 days pregnant. Her last menstrual period (LMP) was estimated to be late January/early February (estimated delivery date 08-NOV-2007). In the end of April 2007, the patient had a spontaneous abortion followed by a dilation & curettage (D & C). Subsequently (date unknown), the patient was diagnosed at the ER with a urinary tract infection (UTI) status post spontaneous abortion and D & C. On 08-MAY-2007, the patient was vaccinated with the second dose of GARDASIL (lot #657005/0314U). She was fully recovered from the spontaneous abortion at that time. On 07-SEP-2007, the patient was vaccinated with the third dose of GARDASIL (lot #657872/0515U). Subsequently, the patient recovered from the UTI. In the follow-up phone call of 07-FEB-2008, the PA reported that she did not consider the spontaneous abortion or UTI as disabling or life threatening. She was unsure if the patient had been hospitalized at all. Upon internal review, spontaneous abortion was considered to be an other important medical event. No further information is available.
VAERS ID: 304880   Vaccination Date: 2008-01-31
Age: 18.0   Onset Date: 2008-01-31   Days later: 0
Gender: Female   Submitted: 2008-02-13
State: Unknown   Entered: 2008-02-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0802USA01815
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ovarian enlargement, Pain
Write-up: Information has been received for the Merck Pregnancy Registry for Gardasil from an 18 year old female with no pertinent medical history or drug reactions/allergies who on 31-JAN-2008 was vaccinated with a first dose of Gardasil injection. There was no concomitant medication. On 03-FEB-2008 or 04-FEB-2008 (3 to 4 days) after receiving the first dose of Gardasil the patient miscarried. The patient was approximately 2 weeks pregnant. The patient was unaware she was pregnant until she miscarried. The physician stated to the patient that her left ovary was swollen. The patient was in alot of pain. The patient was scheduled for a CT scan next week. At the time of reporting the patient has not recovered. On approximately 20-JAN-2008 was the patient's date of last menstrual period. The patient's estimated date of delivery was 26-OCT-2008. No additional information was provided. Upon internal review miscarriage was considered to be an other medical event. Additional information is not expected.
VAERS ID: 305121   Vaccination Date: 2007-11-01
Age: 16.0   Onset Date: 2007-11-01   Days later: 0
Gender: Female   Submitted: 2008-02-18
State: Pennsylvania   Entered: 2008-02-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Current Illness:
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: None
CDC 'Split Type': WAES0802USA02114
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP MERCK & CO. INC.     UN UN
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a consumer concerning her 16 year old daughter with no medical history and no drug allergies, who in November 2007, was vaccinated IM with a 0.5 mL first dose of Gardasil. Concomitant vaccination included Recombivax. Subsequently, the patient was pregnant. In November 2007, the patient had a miscarriage at approximately 16 weeks. The gestation period at the time of the first dose was unknown. The patient was hospitalized for approximately 2-3 days. No laboratory diagnostics were performed. The patient did not discontinue her dosing schedule. The patient was vaccinated with a second dose of Gardasil on 08-FEB-2008. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 306354   Vaccination Date: 2007-04-24
Age: 22.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-03-03
State: Pennsylvania   Entered: 2008-03-04
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 7/9/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0802USA04668
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA MERCK & CO. INC.     UN UN
HPV4 MERCK & CO. INC. 0960F 0 IM UN
MNQ SANOFI PASTEUR     UN UN
VARCEL MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received through the Merck pregnancy registry from a Registered Nurse concerning a 23 year old female who on 24-APR-2007 was vaccinated with GARDASIL (Lot #654535/0960F). Concomitant vaccinations on 24-APR-2007 included MENACTRA, (manufacturer unspecified) and hepatitis A virus vaccine (manufacturer unspecified). The patient received the second dose of GARDASIL (Lot #657006/0188U) on 18-SEP-2007 and then experienced a miscarriage on 06-JAN-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient's estimated delivery date was 16-APR-2008. The patient became pregnant prior to receiving the second dose. Upon internal review, miscarriage is considered to be an other important medical event. Additional information has been requested.
VAERS ID: 306704   Vaccination Date: 2007-08-24
Age: 25.0   Onset Date: 2007-11-27   Days later: 95
Gender: Female   Submitted: 2008-03-05
State: Texas   Entered: 2008-03-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: 17 September 2007: Abdominal ultrasound revealed threatened abortion. Blood work revealed she was blood group O Rhesus positive. Laboratory results showed the subject's hemoglobin was 11.7g/dL, platelet was 385x10^3/uL, white blood cell cou
Previous Vaccinations:
Other Medications: NITROFURANTOIN, ZIDOVUDINE/LAMIVUDINE, NELFINAVIR, LOPINAVIR/RITONAVIR, ORAL CONTRACEPTIVE PILLS
Preexisting Conditions: female, gravida 2 para 1, 1 cesarean section, blood group O Rhesus positive, cardiac murmur (diagnosed in middle school). HIV infected in 2003, and at screening into study, subject's viral load was 1280 copies/mL and CD4 cell count was 725 cells/mm^3 (normal range 484-1159). The subject had a negative pregnancy test on 17 August 2007, and on 24 August 2007, but self administered ur
CDC 'Split Type': 200800579
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ SANOFI PASTEUR   0 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abortion spontaneous, Blood test abnormal, Haemoglobin decreased, Neutrophil count decreased, Platelet count increased, Pregnancy test urine positive, Ultrasound abdomen abnormal, Urinary tract infection, Vaginal haemorrhage, White blood cell count increased
Write-up: Initial report received on 26 February 2008 regarding study protocol P1065 (Reference number: EAE-2008-0175). The following is verbatim from that report: "Summary: The subject is a 25 year-old Gravida 2 Para 1, 1 cesarean section, HIV infected, African American female, who enrolled in the protocol on August 17, 2007. On November 27, 2007, she experienced grade 3 miscarriage. The subject had negative pregnancy tests at study screening on August 17, 2007 and at study entry on August 24, 2007. She also admitted to using birth control as required by the study. On August 17, 2007, at screening, the subject's viral load was 1280 copies/mL. On August 24, 2007, she received the first dose of the study agent, Menactra vaccine. On September 04, 2007, she reported to the clinic where a pregnancy test performed was positive. It was then decided that the subject would not receive any further doses of the study agent but continue with her study visit. On September 17, 2007, at 6 weeks gestation, the subject went to the emergency room with complaints of vaginal bleeding and abdominal cramping. An abdominal ultrasound revealed threatened abortion. Blood work done revealed she is blood group O Rhesus positive. A urinalysis was positive for blood (2+), nitrates numerous bacteria and 3 epithelial cells. She was diagnosed with urinary tract infection and treated with Nitrofurantoin. However, she continued to have cramping and vaginal bleeding through out her pregnancy. On November 27, 2007, the subject was seen by her gynecologist for a routine visit. An abdominal ultrasound was performed which revealed a fetal demise at 12 weeks gestation. On December 02, 2007, she began bleeding vaginally. She was rushed to the hospital and a dilatation and curettage was performed. The subject was discharged the same day." "Assessment of relationship: The site Principal Investigation has assessed the event of miscarriage as probably not related to the study report, Menactra vaccine. The Medical Officer has assessed the event of miscarriage as prob
VAERS ID: 306719   Vaccination Date: 2007-12-18
Age: 20.0   Onset Date: 2007-12-18   Days later: 0
Gender: Female   Submitted: 2008-03-07
State: Unknown   Entered: 2008-03-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: diagnostic laboratory 02/04/08 - pregnancy quantitative test was < 5.0
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Abortion spontaneous
CDC 'Split Type': WAES0802USA06211
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1209U 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Pregnancy test positive
Write-up: Information has been received for the Merck Pregnancy Registry for Gardasil from a licensed practical nurse concerning a 20 year old female with a history of 2 pregnancies and 0 live births (2 miscarriages) who on 18-DEC-2007 was vaccinated with Gardasil (lot# 654540/1209U). The patient's date of last menstrual period was 18-DEC-2007. Subsequently the patient became pregnant. On 04-FEB-2008 the patient experienced a spontaneous abortion. On 04-FEB-2008, a pregnancy quantitative was < 5.0. On 21-FEB-2008 the patient was vaccinated with a second dose of Gardasil (lot# 0530U). Upon internal review spontaneous abortion is considered to be an other medical event. Additional information is not expected.
VAERS ID: 306972   Vaccination Date: 2007-01-01
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-03-12
State: California   Entered: 2008-03-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Unknown
CDC 'Split Type': WAES0803USA00669
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
VARCEL MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician concerning a female (age unknown), who in 2007 was vaccinated with a dose of Gardasil. Concomitant suspect vaccination included Varivax. Subsequently, the patient was pregnant. It was reported that "a couple days" post vaccination the patient had a miscarriage. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 307054   Vaccination Date: 2008-02-12
Age: 18.0   Onset Date: 2008-02-12   Days later: 0
Gender: Female   Submitted: 2008-03-13
State: Unknown   Entered: 2008-03-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/22/2008); Penicillin allergy
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0803USA01259
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received for the Pregnancy Registry for Gardasil from an 18 year old female consumer with Amoxicillin allergy who on 12-FEB-2008 was vaccinated with a first dose of Gardasil (route, site and lot # not reported). There were no concomitant therapies. Her last menstrual period was on 22-JAN-2008 and expected delivery date (EDC) being 28-OCT-2008. She later found out that she had a miscarriage on 06-MAR-2008. The consumer did not report if any laboratory tests were done. No other information was available at this time. Upon internal review "miscarriage" was determined to be an other important medical event. Additional information has been requested.

 

VAERS ID: 307055   Vaccination Date: 2007-12-03
Age: 26.0   Onset Date: 2007-12-12   Days later: 9
Gender: Female   Submitted: 2008-03-13
State: Unknown   Entered: 2008-03-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 12/12/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0803USA01397
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received for the Merck Pregnancy Registry Gardasil from a 26 year old female who in April 2007 and June 2007 was vaccinated with a first and second dose of Gardasil 0.5 mL injection. The third dose of Gardasil was administered on 03-DEC-2007. Subsequently the patient found out she is 4 weeks pregnant on 03-JAN-2008. The patient's LMP date was 12-DEC-2007. Unspecified medical attention was sought. On 06-MAR-2008 the patient had a miscarriage. At the time of reporting it was unknown if the patient had recovered. No additional information was provided. Upon internal review miscarriage was considered to be an other medical event. Additional information is not expected.
VAERS ID: 307481   Vaccination Date: 2008-02-06
Age: 31.0   Onset Date: 2008-02-28   Days later: 22
Gender: Female   Submitted: 2008-03-17
State: California   Entered: 2008-03-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Vitamins, ASA
Preexisting Conditions: The patient had no history of previous pregnancy. She had a history of mitral valve prolapse. There was no illness at the time of vaccination, and no adverse events following prior vaccination.
CDC 'Split Type': 200800759
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV SANOFI PASTEUR EJN233B 1 IM LA
RAB SANOFI PASTEUR A0209 1 IM UN
TYP BERNA BIOTECH, LTD 3001291   PO  
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abortion spontaneous, Haemorrhage
Write-up: Initial report received on 11 March 2008 from a health care professional. A 31-year-old female patient, with a history of mitral valve prolapse, had received a second dose, left arm, intramuscular injection of JE-VAX, lot number EJN233B, and a second dose, left deltoid, intramuscular injection of Imovax, lot number A0209-2, both administered on 06 February 2008; and a fourth dose, oral administration of Vivotif, lot number 3001291, on 07 February 2008. The patient also received a left deltoid, intramuscular injection of Adacel, lot number C2864AA.; a left arm, intramuscular injection of IPOL, lot number A0170-2; a left arm, intramuscular injection of MMR vaccine, lot number 1312U; a right deltoid, intramuscular injection of Fluarix, lot number AFLUA303AA; and a right deltoid, intramuscular injection of Twinrix, lot number AHABBLOOA; on 30 January 2008. The patient's last menstrual period was 20 January 2008. Twenty-two days following the 06 February 2008 immunizations (and 29 days following the 30 January 2008 immunizations), the patient developed abdominal cramping and bleeding with "large pieces of tissue." She was examined by an obstetrician and diagnosed with a miscarriage. Relevant diagnostic testing was reported as none. Concomitant medications included vitamins and aspirin. The patient subsequently recovered from the event.
VAERS ID: 308327   Vaccination Date: 2008-01-30
Age: 31.0   Onset Date: 2008-01-30   Days later: 0
Gender: Female   Submitted: 2008-03-26
State: Unknown   Entered: 2008-03-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/20/2008)
Diagnostic Lab Data: beta-human chorionic 02/27/08
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0803USA01753
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU UNKNOWN MANUFACTURER     UN UN
HEPAB GLAXOSMITHKLINE BIOLOGICALS     UN UN
IPV SANOFI PASTEUR     UN UN
MMR MERCK & CO. INC.     UN UN
TDAP UNKNOWN MANUFACTURER     UN UN
TYP UNKNOWN MANUFACTURER     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a certified nurse practitioner concerning a 31 year old female with no pertinent medical history reported. The patient had her last menstrual period on 20-JAN-2008. On 30-JAN-2008, the patient was vaccainted with MMR II (lot # 1312U). Concomitant therapy also administered on 30-JAN-2008 included TWINRIX, influenza virus vaccine (unspecified) (manufacturer unspecified). poliovirus vaccine inactivated (Vero) (manufacturer unspecified), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and typhoid vaccine live oral (Ty21a) (manufacturer unspecified). Concomitant therapy administered on 06-FEB-2008 included Japanese encephalitis virus vaccine (manufacturer unspecified), and rabies vaccine (unspecified) (manufacturer unspecified). Subsequently, she became pregnant. Her estimated date of delivery was 26-OCT-2008. On 27-FEB-2008, the patient had a pregnancy test. On 28-FEB-2008, the patient miscarried. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the spontaneous miscarriage was determined to be an Other Important Medical Event. Additional information has been requested.
VAERS ID: 308819   Vaccination Date: 0000-00-00
Age: 18.0   Onset Date: 2008-02-01   Days later:
Gender: Female   Submitted: 2008-04-02
State: Unknown   Entered: 2008-04-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: hormonal contraceptives
Preexisting Conditions:
CDC 'Split Type': WAES0803USA04326
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: Information has been received from a consumer concerning her 18 year old daughter with no medical history and no drug allergies, who, on an unspecified date, was vaccinated with a third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient had a miscarriage "a month and a half ago" in approximately February 2008. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. Upon internal review miscarriage was considered to be an other important medical event. Additional information is not available.
VAERS ID: 309078   Vaccination Date: 0000-00-00
Age: 20.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-04-07
State: Unknown   Entered: 2008-04-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0804USA00977
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received, via the Merck pregnancy registry, from an approximately 20 year old female consumer (date of birth given, but onset of events and vaccination/gestation dates not specified), who was vaccinated with the first and second dose of GRADASIL (dates and lot # not reported). Subsequently, "between my second and third dose I was pregnant and ultimately miscarried." The patient sought medical attention, and was seen in an office visit (details not specified). The consumer questioned if miscarriage was a possible side effect of GARDASIL. The date of the third dose was not clarified as before or after miscarriage. The outcome of miscarriage was not specified. Upon internal review, ultimately miscarried was considered to be serious as an other important medical event. No further information was available.
VAERS ID: 309234   Vaccination Date: 2008-01-11
Age: 22.0   Onset Date: 2008-01-11   Days later: 0
Gender: Female   Submitted: 2008-04-09
State: California   Entered: 2008-04-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 11/28/2007)
Diagnostic Lab Data: ultrasound, 01/11/08, reason-early pregnancy ultrasound results-1 gestational sac, positive yolk sac fetal pole; ultrasound, 01/31/08; ultrasound, 02/01/2008, single, CRL approximately 7.9 weeks, no fetal heart tones with embryonic demise
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0803USA05021
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1448U 1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan abnormal
Write-up: Information has been received from a physician concerning a 22 year old female with no medical history and no concurrent conditions, who on 11-JAN-2008 was vaccinated with a second dose of Gardasil (Lot# 659653/1448U). Concomitant therapy included prenatal vitamins (unspecified). Subsequently, the patient was pregnant. The estimated conception date was 12-DEC-2007, the patient's last menstrual period was 28-NOV-2007, and the estimated delivery date was 03-SEP-2008. On 11-JAN-2008 an ultrasound was performed and showed one gestational sac, and was positive for yolksac fetal pole. On 31-JAN-2008 and 01-FEB-2008 repeat ultrasounds were performed and showed a single intrauterine pregnancy, crown-rump length (CRL) was approximately 7.9 weeks, there was no fetal heart tones with embryonic demise. The patient did not have any previous pregnancies and no full-term deliveries. On 08-FEB-2008 the patient experienced a spontaneous abortion nine weeks and one day from her last menstrual period. The products of conception were examined and were normal appearing. The fetus was not normal due to chromosomes 69XXY. At the time of the report, the outcome of the patient was unknown. Upon internal review spontaneous intrauterine embryonic demise was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 309310   Vaccination Date: 2007-06-13
Age: 17.0   Onset Date: 2007-06-13   Days later: 0
Gender: Female   Submitted: 2008-04-10
State: Florida   Entered: 2008-04-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 5/25/2007)
Diagnostic Lab Data: beta-human chorionic, pregnant
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0708USA04003
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Initial and follow up information has been received via the Merck pregnancy registry, from a licensed practical nurse (LPN) and a healthcare professional, concerning a 17 year old female patient with no pertinent medical history and no prior pregnancies, who had her LMP on 25-MAY-2007, was unknowingly pregnant, and on 13-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication. Following the vaccination, the patient took a home pregnancy test, and determined that she was pregnant (estimated date of delivery was 29-FEB-2008). The patient was examined in the office, and the LPN indicated that there were no problems reported. Follow up information indicated that on 11-SEP-2007, the patient experienced a spontaneous abortion (< 20 weeks). No other details were provided. Upon internal review, "spontaneous abortion (< 20 weeks)" was considered to be serious as an other important medical event. Additional information has been requested.
VAERS ID: 309328   Vaccination Date: 2008-02-07
Age: 24.0   Onset Date: 2008-02-07   Days later: 0
Gender: Female   Submitted: 2008-04-10
State: Texas   Entered: 2008-04-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 2/14/2008); Attention deficit disorder; Seasonal allergy
Diagnostic Lab Data: Beta-human chorionic - pregnant; Serum beta-human - pregnant.
Previous Vaccinations:
Other Medications: Adderall tablets; Zyrtec
Preexisting Conditions:
CDC 'Split Type': WAES0802USA05622
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     SC UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received through the pregnancy registry from a physician concerning a 24 year old female nursing student with attention deficit disorder, seasonal allergies, and no allergies to medications, who on 07-FEB-2008 was vaccinated with a 0.5 ml subcutaneous dose of VARIVAX. Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS) and cetirizine hydrochloride (ZYRTEC). The patient became pregnant on 14-FEB-2008. It was reported that the patient had not experienced any difficulties at the time of the report. The patient was seen in the office. No product quality complaint was involved. No other information was provided. Follow-up information received from a registered nurse indicated that on 08-MAR-2008 or 08-MAR-2008 the patient had a spontaneous abortion. Additional information is not expected. Upon internal review the patient's spontaneous abortion was determined to be an other important medical event.
VAERS ID: 310279   Vaccination Date: 2007-12-21
Age: 20.0   Onset Date: 2008-01-10   Days later: 20
Gender: Female   Submitted: 2008-04-17
State: Maine   Entered: 2008-04-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP= 1/10/2008) Non-smoker
Diagnostic Lab Data: ultrasound 03/10/08 fetal demise
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Preexisting Conditions: Pregnancy NOS (LMP= 1/10/2008); Non-smoker
CDC 'Split Type': WAES0804USA01762
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1266U 1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan abnormal
Write-up: Information has been received through the pregnancy registry, concerning a 20 year old female patient, a non smoker, with a history of one pregnancy and one live birth, who on 23-OCT-2007 and 21-DEC-2007 was vaccinated with the first and second doses of Gardasil, respectively (Lot # first dose 658560/1062U, second dose 569437/1266U). Subsequently, the patient became pregnant. It was reported that the patient's last menstrual period (LMP) was 10-JAN-2008. The estimated delivery date was 17-OCT-2008. On 10-MAR-2008 the patient experienced a spontaneous abortion, eight weeks from LMP (reported as 6 5/7 weeks). Diagnostic testing performed on 10-MAR-2008 to assess dates indicated fetal demise. No product quality complaint was involved. Upon internal review, miscarriage was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 311353   Vaccination Date: 2007-11-12
Age: 32.0   Onset Date: 2007-11-12   Days later: 0
Gender: Female   Submitted: 2008-04-22
State: Massachusetts   Entered: 2008-04-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Concomitant Drug Not Reported
Preexisting Conditions:
CDC 'Split Type': MEDI0006198
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN MEDIMMUNE VACCINES, INC.     IN  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test urine positive, Vaginal haemorrhage
Write-up: A serious report of a medically important event of spontaneous abortion in a 32-year-old pregnant woman who was administered FluMist was received from a nurse practitioner. No medical history nor concomitant medications were reported. The patient was in a shelter for the homeless. The patient received FluMist on 12-Nov-2007. At the time of FluMist administration, the patient denied pregnancy or any other contraindication. On 16-Nov-2007, the patient notified the reporter that she was pregnant and in the first trimester of her pregnancy. The pregnancy was confirmed by urine test on an unreported date. In December 2007, the patient experienced bleeding and when examined by an obstetrician-gynecologist (OB-GYN), it was determined that the pregnancy was non-viabe and the patient had experienced a spontaneous abortion. No causality assessment was reported for the pregnancy. The reporter stated that the patient's OB-GYN did not think that the spontaneous abortion was related to FluMist vaccine. The sponsor considered the spontaneous abortion an important medical event.

 

VAERS ID: 311455   Vaccination Date: 2007-10-15
Age: 23.0   Onset Date: 2007-10-15   Days later: 0
Gender: Female   Submitted: 2008-05-01
State: Unknown   Entered: 2008-05-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0710USA03731
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a 23 year old female who on 15-OCT-2007 was vaccinated with her first dose of Gardasil. On 18-OCT-2007 the patient found out she was pregnant. On 22-APR-2008, it was reported by the patient, that on approximately 01-NOV-2007, reported as "about two weeks after calling," that she had lost the baby. She reported that the miscarriage was early in her pregnancy and she was doing fine. Upon internal review, spontaneous abortion was considered to be an other important medical event. No further information is available.
VAERS ID: 311457   Vaccination Date: 2008-04-09
Age: 19.0   Onset Date: 2008-04-09   Days later: 0
Gender: Female   Submitted: 2008-05-01
State: Texas   Entered: 2008-05-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: total serum human, did not show patient was pregnant
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0804USA05085
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin negative, Drug exposure during pregnancy
Write-up: Information has been received from a medical assistant concerning a 19 year old female, who on 09-APR-2008 was vaccinated with a 0.5mL first dose of Gardasil. Subsequently, the patient was pregnant. It was reported that the office did not conduct a pregnancy test prior to the vaccination. The patient called the office to report that she experienced a miscarriage on 21-APR-2008. The patient went to see the physician. A total serum human chorionic gonadotropin test was performed and did not show that the patient was pregnant. On 09-APR-2008 the patient experienced received first dose while pregnant. At the time of the report, the outcome of the patient was unknown. Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 311564   Vaccination Date: 2007-12-05
Age: 21.0   Onset Date: 2007-12-05   Days later: 0
Gender: Female   Submitted: 2008-05-02
State: Unknown   Entered: 2008-05-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 11/8/2007)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0712USA08442
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a 21 year old female consumer that is also the patient, who has no pertinent medical history, drug reaction/allergies or concomitant medication usage. On 05-DEC-2007, the consumer was vaccinated (route and site not reported) with the 1st dose of GARDASIL (lot# not reported). The consumer found out she was pregnant after receiving the 1st dose of GARDASIL. The consumer reported that she was 6 weeks pregnant. The patient did receive unspecified medical attention. No lab diagnostic test were performed. Follow up from the consumer indicated that she had a miscarriage on 31-JAN-2008. She added that "everything is OK now," and added that she had no problems since then. Upon internal review, had a miscarriage was considered to be serious as an other important medical event. No additional information is expected.
VAERS ID: 311853   Vaccination Date: 2007-06-04
Age: 26.0   Onset Date: 2007-06-04   Days later: 0
Gender: Female   Submitted: 2008-05-07
State: Arizona   Entered: 2008-05-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 5/20/2007)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0707USA03114
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Pregnancy test positive
Write-up: Initial and follow-up information has been received from a physician concerning a 26 year old female with no medical history, who on 04-JUN-2007 was vaccinated with a first dose of GARDASIL. There was no concomitant medication. The patient was pregnant. The pregnancy was confirmed by a pregnancy test. At the time of the report, the patient was 8 weeks pregnant and her outcome was unknown. The patient's last menstrual period was 20-MAY-2007 and her estimated delivery date was 27-FEB-2008. The patient had one previous pregnancy and one full term delivery. No product quality complaint was involved. Follow-up information indicated that on 07-AUG-2007 the patient went to the emergency room due to bleeding. The patient experienced a spontaneous abortion. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 312421   Vaccination Date: 2007-03-19
Age: 21.0   Onset Date: 2007-03-19   Days later: 0
Gender: Female   Submitted: 2008-05-15
State: Minnesota   Entered: 2008-05-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 2/14/2007); Specific allergy (drug)
Diagnostic Lab Data: urine beta-human 03/19/07 posit
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0703USA03642
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received through the Merck pregnancy registry, for GARDASIL, from a physician concerning a 21 year old female with codeine allergy who on 19-MAR-2007 was vaccinated intramuscularly in the deltoid with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. Later that same day a urine pregnancy test was positive and the patient found out she was pregnant. (LMP: 14-FEB-2007; EDD: 21-NOV-2007). Unspecified medical attention was sought. On 09-May-2009, telephone follow up information was received from a nurse who reported that the patient miscarried at eleven weeks and three days. Upon internal review, miscarriage was considered to be an other important medical event. No further information is available.
VAERS ID: 312526   Vaccination Date: 2007-05-29
Age: 26.0   Onset Date: 2007-07-13   Days later: 45
Gender: Female   Submitted: 2008-05-16
State: Pennsylvania   Entered: 2008-05-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 6/4/2007); Asthma; Drug hypersensitivity
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: (therapy unspecified); albuterol; ZYRTEC, mg; ALLEGRA; vitamins (unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0708USA01062
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0388U 0 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Menstruation delayed
Write-up: Information has been received from a Nurse for the pregnancy registry, concerning a 26 year old female with asthma and an allergy to Vicodin who on 29-MAY-2007 was vaccinated IM in the left deltoid with a first dose of Gardasil. Concomitant therapy included ALLEGRA, albuterol and vitamins (unspecified). On 13-JUL-2007 the patient was seen in the doctor's office for suppressed menses and later determined to be pregnant. Follow-up information was received from the physician's office. Concomitant therapy also included "DUET DHA" (therapy unspecified) and ZYRTEC. On 29-AUG-2007 the patient had a spontaneous abortion 12 3/7 weeks from LMP. The products of conception were examined and were normal. Upon internal review spontaneous abortion was considered to be an other medical event. Additional information is not expected.
VAERS ID: 312527   Vaccination Date: 2008-01-22
Age: 18.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-05-16
State: Unknown   Entered: 2008-05-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 12/10/2007)
Diagnostic Lab Data: beta-human chorionic 01/28/08 - pt pregnant
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0801USA05893
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from an 18 year old female with no pertinent medical history and no known drug reactions/allergies who on 22-JAN-2008 was vaccinated with a first dose 0.5 mL of GARDASIL. There was no concomitant medication. The patient reported that on 28-JAN-2008 she went to her gynecologist, "had a pap smear done and found out she was pregnant". Her gestation was two weeks and five days. Her last menstrual period was on 10-DEC-2007 and estimated delivery date was 15-SEP-2008. No other information was provided. Follow up information was obtained via telephone call with the patient on 12-MAY-2008 to obtain the patient's obstetrician (OB)/gynecologist (GYN). The patient reported that she was not pregnant any more. When she was asked if she miscarried or decided to terminate, she reported that she "lost it" (date not reported). Upon internal review "lost it" (miscarriage) was determined to be an other important medical event. No additional information is expected.
VAERS ID: 313380   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-05-23
State: Unknown   Entered: 2008-05-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0805USA04719
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from the Merck Pregnancy registry for GARDASIL from a female who was vaccinated with a first dose of GARDASIL. Subsequently the patient became pregnant and had a miscarriage. The patient required an doctor office visit. The patient reported that she felt her "doctor was inept and responsible for this." Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 313382   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-05-23
State: Illinois   Entered: 2008-05-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0805USA04084
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of GARDASIL. The physician reported that the patient did not know she was pregnant, she had a miscarriage. Follow up phone call information provided by a physician's assistant reported that the patient experienced a spontaneous abortion sometime after the first dose of GARDASIL, and prior to the second dose of GARDASIL. The physician's assistant was unable to provide the administration date, dose, or lot numbers. It was reported that the patient's outcome was unknown. Upon internal review, spontaneous abortion was determined to be an other important medical event. No product quality complaint was involved. Additional information has been requested.
VAERS ID: 314518   Vaccination Date: 2007-05-01
Age: 18.0   Onset Date: 2007-05-23   Days later: 22
Gender: Female   Submitted: 2008-05-30
State: Louisiana   Entered: 2008-06-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 5/23/2007); Penicillin allergy
Diagnostic Lab Data: diagnostic laboratory - reports not reported; beta-human chorionic - positive
Previous Vaccinations:
Other Medications: hormonal contraceptives
Preexisting Conditions:
CDC 'Split Type': WAES0707USA03459
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Pregnancy test positive
Write-up: Initial and follow-up information has been received from the Merck Pregnancy Registry from an 18 year old female with a penicillin allergy who in May 2007 was vaccinated with a dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the patient became pregnant. A pregnancy test was performed to confirm the patient's pregnancy. The patient's last menstrual period was on 23-MAY-2007. The patient's estimated date of delivery was 27-FEB-2007. The patient did not continue series of GARDASIL during her pregnancy. Unspecified medical attention was sought. At the time of the initial report, the patient was nine weeks gestation. Follow-up reported that on approximately 07-AUG-2007, the patient miscarried at 11 weeks. It was reported that had no procedures done and was doing "fine." At the time of the follow-up report, the patient was pregnant again (WAES #0805USA06056). Upon internal review, miscarried at 11 weeks was considered to be an other important medical event. Additional

 

VAERS ID: 314520   Vaccination Date: 2008-02-05
Age: 25.0   Onset Date: 2008-02-06   Days later: 1
Gender: Female   Submitted: 2008-05-30
State: Unknown   Entered: 2008-06-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP =2/6/2008); Herpes simplex; Anxiety; Herpes virus infection
Diagnostic Lab Data: ultrasound, 03/19/08, reason-viability result-viable; FHT positive; diagnostic laboratory; ultrasound, 03/25/08, reason-viability result-threatened Ab; viable; ultrasound, 04/07/08, spontaneous abortion; nonviable
Previous Vaccinations:
Other Medications: KLONOPIN; VALTREX; EFFEXOR
Preexisting Conditions: Pyelonephritis; Chlamydial infection; Termination of pregnancy-elective
CDC 'Split Type': WAES0803USA04942
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1448U 1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Condition aggravated, Drug exposure during pregnancy, Foetal heart rate, Haemorrhage, Herpes virus infection, Ultrasound scan abnormal, Ureaplasma infection
Write-up: Initial and follow-up information has been received from a certified medical assistant, for the Pregnancy Registry, concerning a 25 year old female with anxiety, herpes, and no drug allergies, and with a history of pyelonephritis (reported as phylonephritis), caesearean section in 2002, chlamydia, 3 previous pregnancies, 1 full term delivery, 2 elective terminations, who on 29-NOV-2007 was vaccinated IM with a first dose of GARDASIL (lot # 659437/1266U) and on 05-FEB-2008 was vaccinated IM with a second dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included EFFEXOR, KLONOPIN, and VALTREX. The patient was pregnant. The patient's last menstrual period was 06-FEB-2008 and her estimated delivery date was 13-NOV-2008. The patient saw her physician for medical attention. On 19-MAR-2008 an ultrasound was performed for viability and the results were viable, the fetal heart tones were positive. On 25-MAR-2008 an ultrasound was performed for a threatened Ab and the results were viable. On 07-APR-2008 an ultrasound was performed due to first trimester bleeding and the results nonviable and a probable spontaneous abortion. On 07-APR-2008 at 8 4/7 weeks from her last menstrual period the patient experienced a spontaneous abortion. The products of conception were not examined. It was unknown if the fetus was normal. The complications during the pregnancy was first trimester bleeding. Illnesses during the pregnancy were Herpes and Ureaplasma urealyticum. The patient's outcome was unknown. A product quality complaint was not involved. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 315501   Vaccination Date: 2007-06-22
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-06-06
State: Texas   Entered: 2008-06-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0806USA00640
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a licensed visiting nurse (L.V.N) through the Merck pregnancy registry, concerning a female who on 22-JUN-2007 was vaccinated with the first dose of GARDASIL (lot#, route and dose not reported). On 22-AUG-2007 the patient received the second dose of GARDASIL (lot#, route and dose not reported). The nurse reported that the patient then became pregnant and miscarried at 7 weeks gestation. The patient sought unspecified medical attention. On 03-JUN-2008, the third dose of GARDASIL vaccine (lot#, route and dose not reported) was given. No additional information was provided. Upon internal review, the patient's miscarriage was considered an other important medical event. Additional information has been requested.
VAERS ID: 315507   Vaccination Date: 2007-04-20
Age: 29.0   Onset Date: 2007-06-17   Days later: 58
Gender: Female   Submitted: 2008-06-06
State: Montana   Entered: 2008-06-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 6/17/2007)
Diagnostic Lab Data: serum beta-human, 08/10/07 - (HPT and Blood test) positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0708USA03050
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Write-up: Information has been received through the Merck pregnancy registry concerning a 29 year old female with no pertinent medical history or no drug reactions/allergies who on approximately 20-APR-2007 was vaccinated with a first dose of GARDASIL (lot # unknown) injection. On 20-JUN-2007 the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication used. The consumer reported that she had a positive pregnancy test on 10-AUG-2007 (home pregnancy test and blood test). Her last menstrual period date was 17-JUN-2007, and the estimated due date was 23-MAR-2008. At the time of the report, the patient reported she had not had any reactions. Initial and follow up information has been received from the nurse practitioner who indicated that the patient did not carry the pregnancy to term. She indicated that the patient "had significant problems and miscarried the pregnancy." No other records were available. Upon internal review, the patient's miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 315508   Vaccination Date: 2007-02-28
Age: 20.0   Onset Date: 2007-02-28   Days later: 0
Gender: Female   Submitted: 2008-06-06
State: Unknown   Entered: 2008-06-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/28/2007); Bipolar disorder; Depression; Anxiety; Polycystic ovaries; Thalassaemia minor
Diagnostic Lab Data: Urine beta-human, 02/28/07, urine pregnancy test negative; Urine beta-human, 03/23/07, urine pregnancy test positive.
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0703USA04792
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0187U 0 IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin negative, Urine human chorionic gonadotropin positive
Write-up: Initial and follow-up information has been received from a registered nurse for the manufacturing registry of GARDASIL concerning a 20 year old female with bipolar disorder, depression, anxiety, polycystic ovaries and thalassaemia minor who on 28-FEB-2007 was vaccinated with first dose of GARDASIL (Lot #656049/0187U, expiration date 29-SEP-2009). There was no concomitant medication (client told the nurse she was not taking any medications at the time). Prior to vaccination on 28-FEB-2007, urine pregnancy test was performed and was negative. Client presented to the office of 23-MAR-2007 and urine pregnancy test performed was positive for pregnancy. The patient's last menstrual period was 28-JAN-2007. Estimated date of delivery was 04-Nov-2007. Follow-up information indicated that the patient had a miscarriage at approximately 9 weeks gestation on an unspecified date. It was reported that the pregnancy was a spontaneous triplet pregnancy. There were three empty gestational sacs. No fetal heart tones were ever detected and there was no further progression of development. It was reported that the gestational sac sizes were about three to four weeks of development. At the time of the report the patient was pregnant again (WAES# 0806USA00961). The outcome of the patient was unknown. Upon internal review the miscarriage was considered to be an other important medical event. This is one of two reports from the same source. Additional information has been requested.
VAERS ID: 316289   Vaccination Date: 2007-07-05
Age: 21.0   Onset Date: 2007-07-05   Days later: 0
Gender: Female   Submitted: 2008-06-13
State: Virginia   Entered: 2008-06-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 8/14/2007)
Diagnostic Lab Data: Beta-human chorionic, 3 weeks pregnant.
Previous Vaccinations:
Other Medications: Albuterol; WELLBUTRIN; Cough, Cold, and Flu therapies; Hormonal contraceptives; Ibuprofen; Metformin
Preexisting Conditions:
CDC 'Split Type': WAES0709USA00536
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1208F   IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Initial and follow-up information has been received through the Merck Pregnancy Registry from a registered nurse concerning a 21 year old female who on 05-JUL-2007 was vaccinated IM in the left deltoid with a 0.5 ml dose of GARDASIL (lot # 654741/1208F). Concomitant therapy included hormonal contraceptives (unspecified), ibuprofen, cough, cold, and flu therapies (unspecified). On an unspecified date the patient took herself off of these modification due to financial difficulty, albuterol, metformin, and WELLBUTRIN. On an unspecified date the patient went to the emergency room (unspecified reason) and found out she was 3 weeks pregnant. She had an OB/GYN appointment on 05-SEP-2007, results not reported. Her last menstrual period was 14-Aug-2007, with an estimated date of delivery was 20-MAY-2008. In September 2007 the patient experienced a miscarriage. Upon internal review the miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 316290   Vaccination Date: 2007-01-23
Age: 16.0   Onset Date: 2007-01-23   Days later: 0
Gender: Female   Submitted: 2008-06-13
State: Illinois   Entered: 2008-06-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown); Depression
Diagnostic Lab Data: beta-human chorionic, 01/??/07, positive; total serum human, 01/29/07, results pending
Previous Vaccinations:
Other Medications: PAXIL
Preexisting Conditions: Reproductive tract disorder; Miscarriage
CDC 'Split Type': WAES0702USA00083
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Initial and follow-up information has been received from a certified medical assistant and an other health professional through a Merck pregnancy registry concerning a 16 year old female with depression and a history of "female problems" (unspecified) and miscarriage (prior to 1st GARDASIL), who on 23-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL. Concomitant therapy included PAXIL. Subsequently the patient had a positive home HCG test. The patient was examined by her obstetrician on 29-JAN-2007 who ordered a serum HCG test. At the time of this report, results of test were pending. In early 2007, it was reported that at approximately 5-6 weeks gestation the patient had an "early" spontaneous abortion. On an unspecified date, the patient received the second dose of GARDASIL and subsequently she had another miscarriage (dates not reported). Subsequently on an unspecified date, the patient received the third dose of GARDASIL and conceived again (date not reported). The patient's last menstrual period was approximately November 2007 and her estimated delivery date August 2008. It was reported that the patient was doing well with no adverse events. The reporter stated that she did not think any of the events were related to GARDASIL. After internal review, abortion was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 316291   Vaccination Date: 2007-04-24
Age: 21.0   Onset Date: 2007-04-24   Days later: 0
Gender: Female   Submitted: 2008-06-13
State: Florida   Entered: 2008-06-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/24/2007); Penicillin allergy
Diagnostic Lab Data: serum beta-human, positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0705USA00602
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Write-up: Information has been received through a pregnancy registry from a 21 year old female with penicillin allergy who on 24-APR-2007 was vaccinated with a third dose 0.5 mL of GARDASIL. There was no concomitant medication. On 24-APR-2007 the patient experienced vaccine exposure during pregnancy. The patient's last menstrual period was 24-MAR-2007 and the estimated due date was 29-DEC-2007. A blood test was positive for pregnancy. Follow up information has been received from the nurse who reported that the patient had a spontaneous abortion during her pregnancy. The nurse could not confirm the estimated gestational age at the time of the "miscarriage". Upon internal review, the patient's spontaneous abortion was considered to be an other important medical event. This patient experienced another adverse event reported in WAES# 806USA002235. Additional information has been requested.
VAERS ID: 316295   Vaccination Date: 2007-07-09
Age: 18.0   Onset Date: 2007-07-09   Days later: 0
Gender: Female   Submitted: 2008-06-13
State: Unknown   Entered: 2008-06-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0711USA05500
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0389U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Write-up: Initial and follow up information has been received from a registered nurse concerning a 19 year old female who on 09-JUL-2007 was vaccinated IM (site not reported) with a first 0.5ml dose of the GARDASIL (lot# 657736/0389U). The patient was not pregnant at the time of the 1st dose of the GARDASIL. The patient missed her second dose of the GARDASIL. The nurse contacted the patient in November 2007, to let her know she needed to come in for her second dose but the she never came. In December 2007 the patient called the office and said she needed to be seen for pregnancy. Last menstrual period listed in the office chart was "September or October 2007." On 12-DEC-2007 the patient called the office with bleeding. On 13-DEC-2008 the patient had a spontaneous abortion. The nurse reported that the patient has not resumed the series even though they had attempted many times to contact her. Upon internal review the spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 316303   Vaccination Date: 1985-01-01
Age:    Onset Date: 1985-01-01   Days later: 0
Gender: Female   Submitted: 2008-06-13
State: Unknown   Entered: 2008-06-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = unknown)
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0806USA01296
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse concerning a female patient who in 1985 was vaccinated with MMR II. It was reported that the patient was vaccinated while pregnant and that she later miscarried. The nurse reported that the patient was seen in the office (date unspecified). The outcome was reported as recovered. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 316461   Vaccination Date: 2003-01-13
Age: 24.0   Onset Date: 2003-01-29   Days later: 16
Gender: Female   Submitted: 2008-06-17
State: Unknown   Entered: 2008-06-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: None
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH EMERGENT BIOSOLUTIONS FAV063   SC UN
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous, Arthralgia, Caesarean section, Dermatitis contact, Drug exposure during pregnancy, Eczema, Erythema, Foetal disorder, Intra-uterine death, Multiple congenital abnormalities, Nodule on extremity, Oedema peripheral, Rash, Skin warm, Tendonitis, Tenosynovitis, Twin pregnancy
Write-up: reported that with each AVA she received she developed swelling that extended to her elbow associated with redness, warmth and the development of a knot. Each knot would last approx one month. One day after AVA #2 on 29 Jan 03 she reported to the clinic with a new rash over her arms x 2-3 days and denied the use of new products. She was diagnosed with dermatitis. She was seen again in 4 Apr 03 for extension of this rash to her inner thighs and popiteal fossa and was diagnosed with eczematous lesions. She denied any previous hx of skin problems. Currently this rash continues to persist with periods of exacerbations. She was evaluated by Dermatology and through skin testing was found to have a contact dermatitis to 3+ cobalt, 2+nickel, and 1+ formaldehyde. She reports issues of tendonitis involving her knees, feet and wrist since 2005-06. She reported that she received an anthrax vaccine in late June or early of 04 because she found out approx one week later that she was pregnant. The DEERS date base does not verify the administration of AVA #6. It was later discovered that she was pregnant with twins with fatal demise of one twin at 16wks gestation. Ultrasound report noted that one twin had multiple anomalies level 3. The other twin was delivered by C-section at 36-3/7 wks gestation and was healthy. Symptoms: Joint Pain, multiple joints, Miscarriage, Dermatitis, diffuse, generalized, Dermatitis, focal. Dx: 12/2007 Dermatitis, contact and other eczema NOS (692.9), 04/2006 Synovitis NEC (727.09) left knee; 10/01/2005 Tenosynovitis, radial styloid (727.04); 10/2004 Death, intrauterine (656.4) at 15-20 wks gestation, del Feb 05

 

VAERS ID: 316598   Vaccination Date: 2007-04-09
Age: 17.0   Onset Date: 2007-05-14   Days later: 35
Gender: Female   Submitted: 2008-06-18
State: Texas   Entered: 2008-06-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: beta-human chorionic, 05/13/07
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0705USA04331
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA MERCK & CO. INC.     UN LA
HPV4 MERCK & CO. INC. 1424F   IM RA
MNQ SANOFI PASTEUR     UN LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a licensed visiting nurse through the Merck pregnancy registry concerning a 17 year old female patient with no history or allergies to medication, who on 09-APR-2007 was vaccinated intramuscularly into the right deltoid, with a dose of GARDASIL (Lot# 654885/1424F). Concomitant therapy administered into the left deltoid on included a dose of MENACTRA and a dose of VAQTA (MSD). It was noted the patient was not taking other medications. On 13-MAY-2007, a home pregnancy test was performed. On 14-MAY-2007, the patient was determined to be two months pregnant via information from the patient's mother. In June 2007, the patient had a miscarriage and was reported to be approximately 2 months pregnant at the time of the miscarriage. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 316691   Vaccination Date: 2008-02-04
Age: 25.0   Onset Date: 2008-02-04   Days later: 0
Gender: Female   Submitted: 2008-06-19
State: Kansas   Entered: 2008-06-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 4/10/2008); Depression
Diagnostic Lab Data: diagnostic laboratory - no results; diagnostic urinalysis - no results
Previous Vaccinations:
Other Medications: CELEXA mg
Preexisting Conditions:
CDC 'Split Type': WAES0805USA02352
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Public     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Urine analysis
Write-up: Information has been received from the Merck Pregnancy Registry for GARDASIL via a 25 year old female with depression, on CELEXA 20 mg daily, who on 29-OCT-2007 was vaccinated with the first dose of GARDASIL, 0.5 ml, injection form (lot# not specified). The second dose of GARDASIL, (Lot# not specified) was administered on 04-FEB-2008, and the third dose of GARDASIL, (Lot# not specified) was administered on 05-MAY-2008. On an unspecified date, she sought medical attention and had blood and urine tests performed (dates, test names and results were not noted). The patient reported that she was pregnant and her last menstrual period was 10-APR-2008, her estimated due date was calculated to be 16-JAN-2009. Follow-up information reported on 20-MAY-2008, 4 to 6 weeks from her last menstrual period, the patient had a spontaneous abortion. It was reported that the products of conception were not examined and it was unknown if the fetus was normal. Upon internal it was reported that spontaneous was an other important medical event. Additional information has been requested.
VAERS ID: 317113   Vaccination Date: 2007-08-06
Age: 18.0   Onset Date: 2007-08-06   Days later: 0
Gender: Female   Submitted: 2008-06-23
State: North Carolina   Entered: 2008-06-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Motor vehicle accident
CDC 'Split Type': WAES0709USA03322
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0388U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Initial and follow up information has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 06-AUG-2007 was vaccinated intramuscularly in the deltoid with the first dose of GARDASIL (lot # 657622/0388U). It was reported that at the time of vaccination the patient was not pregnant. It was reported that the patient's last menstrual period was on 01-AUG-2007 and not on 01-AUG-2006 as it was previously reported. Four weeks after vaccination the patient was involved in a motor vehicle accident. After the motor vehicle accident the patient found out that she was pregnant. The pregnancy was confirmed (method unknown). At the time of the report it was unknown how far along the patient was in her pregnancy. On 12-JUN-2008 a telephone call was made to the doctor's office to obtain pregnancy outcome information and a message was left. On 13-JUN-2008 the nurse called back and reported that the patient "had a miscarriage early on in her pregnancy." She had no further information. Upon internal review patient having a miscarriage in her early pregnancy was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 317119   Vaccination Date: 2008-04-01
Age: 17.0   Onset Date: 2008-04-01   Days later: 0
Gender: Female   Submitted: 2008-06-23
State: New York   Entered: 2008-06-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: diagnostic laboratory, bloodwork- no results reported; ultrasound, 05/29/2008, fetal pole not identified; "no gestational sac"
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0806USA03354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood test, Drug exposure during pregnancy, Emotional distress, Haemorrhage, Laboratory test, Ultrasound scan abnormal
Write-up: Information has been received from the mother of a consumer and a health professional for the pregnancy registry for GARDASIL, concerning a 17 year old female with pertinent medical history reported as unremarkable, who on an unspecified date in April 2008, was vaccinated with the first dose of GARDASIL, IM in the arm. There was no concomitant medication. On 22-MAY-2008 the patient received the second dose of GARDASIL. Subsequently, she became pregnant. The patient sought unspecified medical attention and had blood work. No results were provided. On 29-MAY-2008, the patient had a fetal ultrasound which revealed that the fetal pole was not identified and there was "no gestational sac." The patient's last menstrual period or weeks of gestation were not reported. The patient had a miscarriage on 11-JUN-2008. At the time of the report, the daughter was still having clots and bleeding due to the miscarriage, and was emotionally distressed. No other information was provided. Upon internal review it was determined that miscarriage was an other important medical events. Additional information has been requested.
VAERS ID: 317345   Vaccination Date: 2008-02-11
Age: 21.0   Onset Date: 2008-02-25   Days later: 14
Gender: Female   Submitted: 2008-06-19
State: Florida   Entered: 2008-06-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Ultrasound done on 23 January 2008 to determine size and dates.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: No known allergies. Has a history of depression. Past obstetric history not reported.
CDC 'Split Type': 200800641
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR C2888A   UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan
Write-up: Initial report received on 03 March 2008 from a health care professional. A 21 year old female patient received on 11 February 2008 a dose of ADACEL (lot# C2888AA), dosage, route, and site not reported. It was determined that the patient was 11.4 weeks pregnant at the time of vaccination. Her last menstrual period (LMP) was not reported. The subject's prenatal testing included an ultrasound done on 23 January 2008 to determine size and dates. The Estimated Date of Confinement (EDC) is 26 August 2008. Past obstetric history was not reported. The patient had no allergies and had a history of depression. No adverse event was reported. Follow-up information received on 18 June 2008 via telephone contact from the original reporter who is a nurse. Per the reporter, the patient experienced a spontaneous abortion approximately two weeks after receiving the ADACEL vaccine. Per this new information, the case was upgraded to serious.
VAERS ID: 317703   Vaccination Date: 2007-04-03
Age: 28.0   Onset Date: 2007-04-03   Days later: 0
Gender: Female   Submitted: 2008-06-26
State: Texas   Entered: 2008-06-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: beta-human chorionic, ?/?/07, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0704USA01148
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received through the Merck pregnancy registry from a registered nurse concerning a pregnant 28 year old female who on 03-APR-2007 was vaccinated with a dose of VARIVAX (Oka/Merck). The patient sought unspecified medical attention. No adverse reactions were reported. Follow up information received from the registered nurse indicated that the patient had a positive pregnancy test at home. Subsequently, the patient experienced some bleedings and had a miscarriage at approximately 4 weeks gestation. Upon internal review, miscarriage was determined to be an other important medical event. Additional information is not expected.
VAERS ID: 317974   Vaccination Date: 2008-01-16
Age: 17.0   Onset Date: 2008-05-28   Days later: 133
Gender: Female   Submitted: 2008-06-30
State: Pennsylvania   Entered: 2008-07-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/2/2008); Penicillin allergy
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0806USA08184
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Write-up: Information has been received from a physician concerning a 17 year old female with penicillin allergy who on 16-JAN-2008 was vaccinated with the first dose of GARDASIL. The physician reported that the patient's last menstrual period was on 02-MAR-2008. On 28-MAY-2008, the patient experienced a miscarriage. On 23-Jun-2008 she would receive the second dose of GARDASIL. At the time of the report, the patient had recovered. The patient sought medical attention at the physician's office. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 318283   Vaccination Date: 2008-04-23
Age: 18.0   Onset Date: 2008-04-23   Days later: 0
Gender: Female   Submitted: 2008-07-03
State: Nebraska   Entered: 2008-07-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = 4/11/2008)
Diagnostic Lab Data: ultrasound, 05/28/08, Results not reported; serum alpha-human, 05/28/08, result not reported; serum progesterone test, 05/28/08, Results not reported
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0807USA00072
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0152X 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy, Progesterone, Ultrasound scan, Uterine dilation and curettage
Write-up: Information has been received from a licensed practical nurse through the Merck Pregnancy Registry concerning an 18 year old female who on 23-APR-2008 was vaccinated with a first dose of GARDASIL, 0.5mL intramuscularly (lot# 0152X). There was no concomitant medication. The patient became pregnant after receiving the first dose of GARDASIL. The patient's last menstrual period was 11-APR-2008. On 28-MAY-2008 the patient had labs and diagnostic studies including HCG and progesterone levels and ultrasound. On 01-JUN-2008 the patient was hospitalized for a dilatation and curettage (D&C) because she miscarried. The reason for the miscarriage was unknown, but believed to be spontaneous. She was discharged the same day. The patient's estimated due date was 16-JAN-2009. On 16-JUN-2008, the patient received a second dose of GARDASIL (lot# 0250X). No further detail was provided. Additional information has been requested.
VAERS ID: 318544   Vaccination Date: 2007-08-23
Age: 22.0   Onset Date: 2007-08-23   Days later: 0
Gender: Female   Submitted: 2008-07-08
State: New York   Entered: 2008-07-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 8/2/2007)
Diagnostic Lab Data: urinalysis - results not reported
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0709USA00992
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine analysis
Write-up: Initial and follow up information has been received from a 23 year old female consumer through the Merck Pregnancy registry and an other health professional who on approximately 23-JUN-2007 was vaccinated with 0.5 ml of a first dose GARDASIL. There was no concomitant medication. On 23-AUG-2007 the patient was vaccinated with second dose of GARDASIL. On 06-SEP-2007 the patient reported that she was pregnant. The patient's last menstrual period was 02-AUG-2007. The estimated delivery date was 08-MAY-2007. Unspecified medical attention was sought. A urine test was performed (results not reported). On 26-JUN-2008, it was reported that the patient had a pregnancy loss at 20 weeks estimated gestational age (EGA) and was then seen for a postpartum visit in January after her 20 week loss. At the time of this report, the patient's outcome was unknown. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 318638   Vaccination Date: 2008-05-21
Age: 17.0   Onset Date: 2008-05-21   Days later: 0
Gender: Female   Submitted: 2008-07-09
State: Unknown   Entered: 2008-07-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 4/1/2008)
Diagnostic Lab Data: ultrasound, 06/03/08 - 8 + 5 weeks; urine beta-human, 05/21/08 - positive; urine beta-human, 05/17/08 - negative
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0805USA05817
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan normal, Urine human chorionic gonadotropin negative, Urine human chorionic gonadotropin positive
Write-up: Initial and follow up information has been received from a physician and a nurse practitioner concerning a 17 year old female no past medical history reported, and no previous pregnancies, who on 21-MAY-2008 (also reported as April 2008) was vaccinated with a 0.5 mL dose of GARDASIL and then discovered that she was pregnant. No concomitant medications were reported. No adverse effects reported. The patient sought unspecified medical attention in the office. The patient was referred to an obstetrician for obstetrical care. The patient's last menstrual period was 01-APR-2008 and estimated date delivery is 07-JAN-2009. A urine pregnancy test in the office on 17-MAY-2008 was negative and on 21-MAY-2008 the urine pregnancy test was positive. On 03-JUN-2008 ultrasound results showed that the patient was 8 weeks and 5 days pregnant. On 19-JUN-2008 the patient had a spontaneous abortion at nine weeks. Pathology and chromosomal testing was pending. Spontaneous abortion was considered to be an other important medical event. No further information is available.

 

VAERS ID: 318643   Vaccination Date: 2008-03-25
Age: 42.0   Onset Date: 2008-04-07   Days later: 13
Gender: Female   Submitted: 2008-07-08
State: Minnesota   Entered: 2008-07-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: The patient had a mammogram completed on 25 March 2008 (results not reported). On 07 April 2008, the patient had an ultrasound that did not show a viable pregnancy.
Previous Vaccinations:
Other Medications: Prenatal Vitamins
Preexisting Conditions: Allergy to Amoxicillin. Previous obstetric history: 1 previous pregnancy with pre-term delivery (6 months); child expired due to chromosomal anomaly (Trisomy 18).
CDC 'Split Type': 200800939
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR C2767AA 0 IM LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Mammogram normal, Ultrasound scan abnormal
Write-up: This case was received by a health professional on 31 March 2008. A 42-year-old female patient, with an allergy to Amoxicillin, received a left deltoid booster injection of ADACEL (lot number C2767AA) on 25 March 2008. The patient was pregnant at the time of vaccination, and an ultrasound on 31 March 2008 showed a viable pregnancy with an estimated delivery date of 06 November 2008. Obstetric history included one previous pregnancy, which resulted in a pre-term delivery at six months; the baby expired due to unspecified chromosomal anomalies. No adverse events were reported following vaccination. Follow-up information received on 07 July 2008 from the original reporter who is a health care professional. The patient's obstetrical history was clarified, and the pre-term delivery at six months resulted in the baby expiring due to Trisomy 18 chromosomal abnormality. For the current pregnancy, the date of the patient's last menstrual period was on 01 January 2008; with an expected date of delivery on 12 November 2008. The patient had a mammogram completed on 25 March 2008 (results not reported). On 07 April 2008, the patient had an ultrasound that did not show a viable pregnancy. The patient was considered to have a spontaneous abortion prior to 20 weeks gestation as confirmed by ultrasound on 07 April 2008. The patient was healthy during the pregnancy. The recovery status of the patient was not provided. Due to this new information, this case was upgraded to serious.
VAERS ID: 318707   Vaccination Date: 2008-03-24
Age: 29.0   Onset Date: 2008-03-24   Days later: 0
Gender: Female   Submitted: 2008-07-10
State: Michigan   Entered: 2008-07-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 2/18/2008); Hepatitis B positive; Fruit allergy
Diagnostic Lab Data: urine beta-human, 03/31?/08, posit
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0804USA00193
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP UNKNOWN MANUFACTURER PMCC2775AA   UN UN
MMR MERCK & CO. INC.     UN UN
VARCEL MERCK & CO. INC. 1760U   SC UN
Administered by: Public     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Urine human chorionic gonadotropin positive
Write-up: Information has been received through the Merck pregnancy registry from a nurse concerning a 29 year old female consumer with hepatitis b positive and pineapple allergy who on 24-MAR-2008 was vaccinated SQ with one dose of 0.5ml of VARIVAX (Oka/Merck) (lot # 659607/1760U). Suspect vaccination included MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). Concomitant vaccination included DTaP. The nurse reported that the patient is now pregnant. The patient's LMP was reported as 18-FEB-2008. Medical attention was sought, the patient called the office. A urine pregnancy test confirmed the pregnancy. No symptoms were reported. It was noted that the patient was to schedule an appointment with the physician. At the time of the report the outcome of the pregnancy was unknown. There was no product quality complaint involved. Additional information has been requested. Additional information has been received which reported that the patient had a spontaneous abortion on 09-Apr-2008 (7 weeks from the patient's LMP). The lot number for DTaP was reported as PMCC02775AA. It was reported that no other medications were used during this pregnancy. Upon internal review, it was determined that spontaneous abortion was an other important medical event.
VAERS ID: 318822   Vaccination Date: 0000-00-00
Age: 16.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-07-11
State: Illinois   Entered: 2008-07-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown); Depression
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: PAXIL
Preexisting Conditions: Reproductive tract disorder; Miscarriage
CDC 'Split Type': WAES0807USA01381
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Reaction to previous exposure to any vaccine
Write-up: Initial and follow-up information has been received from a certified medical assistant and an other health professional through a Merck pregnancy registry concerning a 16 year old female with depression and a history of "female problems" (unspecified), miscarriage (prior to first GARDASIL( and early spontaneous abortion (WAES #0702USA00083) who on 23-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL. On an unspecified date in 2007, the patient received the second dose of GARDASIL. Concomitant therapy included PAXIL. Subsequently on an unspecified date in 2007, the patient had another miscarriage (date not reported). The reporter stated that she did not think the events were related to GARDASIL. After internal review, spontaneous abortion was considered to be an other important medical event. It was also reported that this patient was vaccinated with the first dose of GARDASIL and experienced adverse events (WAES #0702USA00083). Additional information is not expected.
VAERS ID: 318978   Vaccination Date: 2007-03-01
Age: 25.0   Onset Date: 2007-05-17   Days later: 77
Gender: Female   Submitted: 2008-07-14
State: Virginia   Entered: 2008-07-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 5/17/2007); Contraception
Diagnostic Lab Data: beta-human chorionic, 06/13/07 - positive
Previous Vaccinations:
Other Medications: LEXAPRO; NUVARING
Preexisting Conditions: Dysplasia; Loop electrosurgical excision procedure
CDC 'Split Type': WAES0706USA03490
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0187U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL concerning a 25 year old female with a history of dysplasia and loop electrosurgical excision procedure (LEEP performed in 2003) and no drug reactions and allergies who on 01-MAR-2007 was vaccinated with GARDASIL (lot number 656049/0187U) 0.5 ml IM. Concomitant therapy included NUVARING and LEXAPRO. The nurse reported that on 13-JUN-2007 the patient was vaccinated with another dose of GARDASIL (Lot number 657737/0522U) 0.5 mL IM. Medical attention was sought. On 13-JUN-2007 a beta-human chorionic gonadotropin test (unspecified) was performed and the results were positive for pregnancy. No symptoms have been reported. No further information is available. The date of the last menstrual period is 17-MAY-2007. The estimated date of delivery is 21-Feb-2008. Follow-up information was received via telephone from a licensed practical nurse. The patient had an early spontaneous miscarriage at 6+ weeks EGA. Additionally it was reported that the patient had been using the NUVARING when the patient conceived. Upon internal review spontaneous abortion was considered to be an other medical event. Additional information is not expected.
VAERS ID: 319812   Vaccination Date: 2008-05-21
Age: 23.0   Onset Date: 2008-05-21   Days later: 0
Gender: Female   Submitted: 2008-07-18
State: Unknown   Entered: 2008-07-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 4/2/2008); Asthma
Diagnostic Lab Data: ultrasound, 05/23/08 - fetus 5 weeks, no problems
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0807USA02664
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1267U 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan normal
Write-up: Information has been received from a nurse practitioner concerning a 23 year old white female with mild asthma, and no previous pregnancies, who on 21-MAY-2008 was vaccinated with the first dose of GARDASIL and then discovered that she was pregnant. Concomitant medications included prenatal vitamin with folic acid. The patient's last menstrual period was 02-APR-2008 and estimated date of delivery is 06-JAN-2009. On 23-MAY-2008 ultrasound results showed that the fetus was 5 weeks and there were no problems. On 04-JUN-2008 the patient had a spontaneous abortion at five weeks, four days. At the time of this report the patient's outcome was unknown. Upon internal review, the spontaneous abortion was considered to be an other important medical event. No further information is available.
VAERS ID: 320083   Vaccination Date: 2008-05-29
Age: 27.0   Onset Date: 2008-05-29   Days later: 0
Gender: Female   Submitted: 2008-07-21
State: South Carolina   Entered: 2008-07-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 5/8/2008)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0807USA02502
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Write-up: Information has been received from a physician through the Merck pregnancy registry for GARDASIL concerning a 27 year old female who on 29-MAY-2008, was vaccinated with the first dose of GARDASIL, 0.5ml, IM and is now pregnant. On 08-MAY-2008, the patient had her last menstrual period (LMP) (estimated date of delivery 12-FEB-2009). On 14-JUL-2008, the patient was experiencing a miscarriage. The patient sought medical attention at the physician's office. On 14-JUL-2008, the patient was scheduled for a Dilation and Curettage (D&C) procedure. At the time of reporting, the outcome was unknown. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 320834   Vaccination Date: 2008-05-22
Age:    Onset Date: 2008-05-22   Days later: 0
Gender: Female   Submitted: 2008-07-29
State: Unknown   Entered: 2008-07-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0807USA04758
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1968U   IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL, concerning a female patient with a history of miscarriage who on 22-MAY-2008 was vaccinated with a dose of GARDASIL (lot # 660389/1968U) intramuscularly. The nurse practitioner reported that on 05-JUN-2008, the patient had a miscarriage. The last menstrual period and weeks gestation was not reported. It is unknown if the patient sought medical attention. A lot check has been initiated. Upon internal review, miscarriage was considered an other important medical event. Additional information has been requested.
VAERS ID: 320917   Vaccination Date: 2008-04-25
Age: 15.0   Onset Date: 2008-05-09   Days later: 14
Gender: Female   Submitted: 2008-07-30
State: Oregon   Entered: 2008-07-31
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: beta-human chorionic
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Chickenpox
CDC 'Split Type': WAES0807USA05097
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with a history of chickenpox disease at age 5 and no allergies who on 25-APR-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM. The patient at the time of vaccination of the first dose indicated she was not pregnant. On approximately 09-MAY-2008, the patient found out she was pregnant. The patient started at an unspecified date and went to the hospital. The hospital informed her on 01-JUN-2008 the patient had a miscarriage. On 25-JUL-2008 the patient was vaccinated with the second dose of GARDASIL 0.5 ml IM. The patient sought medical attention and told the nurse at an office visit. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested
VAERS ID: 320926   Vaccination Date: 2008-05-01
Age: 19.0   Onset Date: 2008-05-01   Days later: 0
Gender: Female   Submitted: 2008-07-30
State: California   Entered: 2008-07-31
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: beta-human chorionic, ?/?/08 - confirmed
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: Splenic rupture
CDC 'Split Type': WAES0807USA04840
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a 19 year old female, for the Pregnancy Registry for GARDASIL concerning herself with a history of ruptured spleen several years ago which was healed and no known drug reactions/allergies who in early May 2008, was vaccinated with a dose of GARDASIL. There was no concomitant medication. Subsequently the patient learned that she was pregnant. Her last menstrual period was on 09-MAY-2008 and the estimated delivery date was 13-FEB-2009. On 03-JUL-2008 the patient was hospitalized at a local hospital and had a miscarriage. The patient also sought medical attention in the physician's office. The patient's miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 321028   Vaccination Date: 2007-10-24
Age: 35.0   Onset Date: 2007-12-01   Days later: 38
Gender: Female   Submitted: 2008-07-28
State: Wisconsin   Entered: 2008-08-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: "None"
Previous Vaccinations:
Other Medications: NASONEX
Preexisting Conditions: The patient had one prior pregnancy that resulted in a full term, normal outcome. Past medical history was denied. From new information received on 25 July 2008, the patient experienced no illnesses during her current pregnancy. The patient had no other vaccinations within four weeks of 24 October 2007.
CDC 'Split Type': 200704125
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU SANOFI PASTEUR U2437AA 4 IM UN
TDAP SANOFI PASTEUR C2842AA 0 IM UN
Administered by: Private     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Initial report received on 30 November 2007 from a health care professional. A 35-year-old female patient had received an intramuscular injection of ADACEL, lot number C2842AA, on 24 October 2007. Site of administration was not provided. The patient's last menstrual period was 20 October 2007. It was determined that the patient was pregnant. The estimated date of delivery was uncertain at the time of this report. Current medications included Nasonex. Per the reporter, the patient did not experience any adverse event. Follow-up information was received from the health professional on 16 June 2008. In addition to ADACEL, the patient also received an intramuscular injection of FLUZONE (lot number U2437AA) on 24 October 2007. The reporter did not consider the patient to be pregnant at the time of vaccination, as the date of last menstrual was 20 October 2007 and the patient received the vaccines on 24 October 2007. No additional information was provided. Follow-up information received on 25 July 2008 from the original reporter who is a health care professional. The ADACEL and FLUZONE SV 2007-2008 administered to the patient on 24 October 2007 were the first, and fifth doses the patient had received of these vaccines respectively. The patient's estimated date of delivery was on July 28, 2008; however the patient experienced a spontaneous abortion (also reported as miscarriage) approximately two months post-vaccination of one single fetus beginning in December 2007 that was confirmed on 02 January 2008. The patient was less than 20 weeks gestation. The reason for the spontaneous abortion was not known, but the patient's Beta HCG's levels had been decreasing in value that indicated a "miscarriage." The patient had not received any prior treatments for infertility, and had not experienced any illnesses during the pregnancy. No prenatal testing had been completed. At the time of this report, it was "unknown" if the patient had recovered. After review of this new information, this case was upgraded to serious.

 

VAERS ID: 321290   Vaccination Date: 2008-02-01
Age: 17.0   Onset Date: 2008-06-23   Days later: 143
Gender: Female   Submitted: 2008-08-04
State: Pennsylvania   Entered: 2008-08-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? Yes
Current Illness: Pregnancy NOS (LMP = 2/15/2008)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: nadolol
Preexisting Conditions:
CDC 'Split Type': WAES0807USA05280
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood test, Drug exposure during pregnancy, Ultrasound scan
Write-up: Information has been received from a consumer for the pregnancy registry for GARDASIL, concerning her 18 year old daughter who in February 2008, was vaccinated with the first dose of GARDASIL 0.5 ml for HPV prophylaxis. Concomitant therapy included nadolol. On an unspecified date, the physician was unaware the patient was pregnant and vaccinated her with the second dose of GARDASIL. The consumer reported that on approximately 23-JUN-2008, her daughter had a miscarriage after getting the second dose of GARDASIL; and had to stay in the hospital for 5 to 6 days. The patient was 4 and a half months pregnant. On an unspecified date, a blood work and ultrasound were done (results not provided). Her LMP was 15-FEB-2008 and EDD was 21-NOV-2008. The patient sought medical attention. Additional information has been requested.
VAERS ID: 321508   Vaccination Date: 2008-06-06
Age: 15.0   Onset Date: 2008-06-06   Days later: 0
Gender: Female   Submitted: 2008-08-06
State: Unknown   Entered: 2008-08-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0807USA05581
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Write-up: Information has been received for the pregnancy registry for GARDASIL from a nurse practitioner concerning a 15 year old female patient who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL IM. The day after receiving the first dose of GARDASIL, the patient found out she was pregnant (gestation or last menstrual period of "1 month"). On 11-JUN-2008 the patient started bleeding and went to the emergency room on 17-JUN-2008, where it was determined she had a miscarriage. Upon internal review, miscarriage was considered to be other important medical event. Additional information has been requested.
VAERS ID: 322159   Vaccination Date: 2007-10-30
Age: 19.0   Onset Date: 2007-10-30   Days later: 0
Gender: Female   Submitted: 2008-08-13
State: Unknown   Entered: 2008-08-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: ultrasound, 10/30/07 - positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Allergic reaction to antibiotics
CDC 'Split Type': WAES0710USA07061
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1266U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy, Ultrasound scan
Write-up: Information has been received through the Merck pregnancy registry from a health professional concerning a 19 year old female patient with a history of allergic reaction to FLAGYL who on 30-OCT-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 659437/1266U). An ultrasound performed on 30-OCT-2007, following vaccination with GARDASIL, confirmed that the patient was pregnant (LMP= end of September). No other symptoms were noted. The patient sought unspecified medical attention. This is a consolidation of reports regarding the same patient. Follow up information was received. The patient miscarried at the end of December 2007. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 322398   Vaccination Date: 2008-05-07
Age: 18.0   Onset Date: 2008-07-23   Days later: 77
Gender: Female   Submitted: 2008-08-15
State: Louisiana   Entered: 2008-08-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 4/11/2008)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0808USA01180
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP MERCK & CO. INC.     UN UN
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage
Write-up: Information has been received for the pregnancy registry for GARDASIL from an 18 year old female patient, with no pertinent medical history and no drug reactions/allergies, who on 07-MAY-2008, was vaccinated with GARDASIL. Concomitant therapy included RECOMBIVAX HB the same day of the GARDASIL. The patient conceived on 03-MAY-2008. The mother reported that her daughter received GARDASIL and had a miscarriage two weeks ago. The mother reported that her daughter went to the hospital to have dilatation and curettage; however she did not stay in the hospital overnight. The patient sought unspecified medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 322550   Vaccination Date: 2008-06-10
Age: 25.0   Onset Date: 2008-06-10   Days later: 0
Gender: Female   Submitted: 2008-08-18
State: New Jersey   Entered: 2008-08-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy (LMP = 4/16/2008); Drug hypersensitivity
Diagnostic Lab Data: ultrasound, 05/27/08, negative; serum beta-human, positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0807USA00801
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1740U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion missed, Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pain, Ultrasound scan normal
Write-up: Initial and follow-up information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 25 year old female with allergy to TORADOL who on 10-JUN-2008 was vaccinated intramuscularly with the first and only 0.5 ml dose of GARDASIL (lot no. 659962/1740U). There was no concomitant medication. The physician reported that on 27-MAY-2008 the patient had an ultrasound due to complaints of "pain" and the result was negative. The patient had a history of "negative menses". On 12-JUL-2008 the patient had a spontaneous abortion when she was eight weeks pregnant. On the same day, the patient had an evaluation due to a (+) serum beta-human chorionic gonadotropin (missed abortion). The patient saw the physician to seek unspecified medical attention. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 323854   Vaccination Date: 0000-00-00
Age: 17.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-08-29
State: Oklahoma   Entered: 2008-09-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0808USA04715
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female who was vaccinated with GARDASIL. It was reported that the patient was pregnant when she was given GARDASIL. The patient had a miscarriage 1 week after the third dose of GARDASIL was given (date unspecified). It was unspecified if the patient sought medical attention or not. Upon internal review miscarriage was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.
VAERS ID: 324289   Vaccination Date: 2008-04-11
Age: 23.0   Onset Date: 2008-04-20   Days later: 9
Gender: Female   Submitted: 2008-09-03
State: Washington   Entered: 2008-09-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: 18 April 2008 - ultrasound: showed no embryonic pole, but there was a positive yolk sac. Showed an empty uterus - spontaneous miscarriage.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: The patient's past obstetric history included one live full-term birth with no congenital anomalies. No medical history or current medications were reported. Follow-up information received on 29 August 2008: The patient's obstetric history included four prior pregnancies, of which one had been a full term live birth with no congenital anomalies. It was unknown if the patient had an
CDC 'Split Type': 200801143
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS AHBVB438AA   IM RA
MMR MERCK & CO. INC. 0040X 1 SC RA
TDAP SANOFI PASTEUR C2889AA   IM LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Pregnancy test urine positive, Ultrasound scan abnormal
Write-up: Based upon follow-up information received 29 August 2008, this case was upgraded to serious. Initial report received on 21 April 2008 from a health care professional. A 23 year old female patient received on 11 April 2008 an intramuscular left deltoid 0.5 ml injection of ADACEL (lot# C2889AA), and intradermal left forearm 0.1 ml injection of TUBERSOL (lot# C2805AA), a subcutaneous right arm 0.5 ml injection of MMR (Merck, lot# 08656), and an intramuscular right deltoid 0.5 ml injection of ENGERIX (GSK, lot # AHBVB438AA). It was determined that the patient was pregnant at the time of vaccination. Her last menstrual period was 04 March 2008 and her expected date of confinement was 09 December 2008. No prenatal testing was reported. The patient's past obstetric history included one live full-term birth with no congenital anomalies. No medical history or current medications were reported. No adverse event was reported. Follow-up information was received on 29 August 2008 from a health care professional. The patient's obstetric history included four prior pregnancies, of which one had been a full term live birth with no congenital anomalies. It was unknown if the patient had any elective or spontaneous abortions, prior to, or greater than 20 weeks gestation, other than the pregnancy pertaining to the reported event which occurred on 20 April 2008. The patient had a positive urine pregnancy test on 18 April 2008. She presented to the emergency room on 20 April 2008 at which time an ultrasound showed an empty uterus - spontaneous miscarriage. At that time, her HCG was 2857; and had previously been 3071 on 18 April 2008. According to medical records received, her ultrasound showed no embryonic pole, but there was a positive yolk sac, and the patient was sent home with precautions. She had significant bleeding when she passed "a lot of stuff" that looked like it may have been tissue. She had a follow-up evaluation on 08 May 2008 at which time she discussed an interest in birth control. Her quantitative H
VAERS ID: 325332   Vaccination Date: 2007-10-05
Age: 16.0   Onset Date: 2008-03-14   Days later: 161
Gender: Female   Submitted: 2008-09-16
State: Unknown   Entered: 2008-09-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: beta-human chorionic, 03/14/08, positive; beta-human chorionic, ?/?/08, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0809USA01412
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a certified medical assistant for the pregnancy registry for GARDASIL, concerning a 16 year old female who on 27-JUL-2007 was vaccinated with the first dose of GARDASIL, 0.5 mL, I.M. and on 05-OCT-2007 with the second dose of GARDASIL. On 14-MAR-2008, the patient was scheduled to receive a third dose of the series, but the patient had a positive pregnancy test and the third dose was not given. On 17-MAR-2008, the patient had a miscarriage of the pregnancy. The reporter stated that the patient has since become pregnant again. On an unspecified date, positive pregnancy test since having miscarriage was performed (WAES # 0809USA01854). The patient sought unspecified medical attention. Upon internal review, miscarriage of the pregnancy was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 325831   Vaccination Date: 2008-02-15
Age: 23.0   Onset Date: 2008-02-15   Days later: 0
Gender: Female   Submitted: 2008-09-22
State: Unknown   Entered: 2008-09-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/19/2008); Shellfish allergy
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0802USA04467
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a 23 year old female with a shellfish allergy who on 15-FEB-2008 was vaccinated with the first dose of GARDASIL. The patient found out on 19-FEB-2008 that she was pregnant. Her LMP is estimated as 19-JAN-2008. Follow up information has been received from a 23 year old female that reported that in March 2008, she had a miscarriage. She said she was fine now, and doing well. Upon internal review miscarriage was determined to be an other important medical event. Additional information is not expected.
VAERS ID: 326099   Vaccination Date: 2007-11-16
Age: 14.0   Onset Date: 2008-01-26   Days later: 71
Gender: Female   Submitted: 2008-09-24
State: Arkansas   Entered: 2008-09-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: ultrasound, 04/09/08, 9 2/7 w lmp; urethral C., results pending; Pap test, results pending; urine beta-human, positive
Previous Vaccinations:
Other Medications: [therapy unspecified]
Preexisting Conditions: Excess sweating
CDC 'Split Type': WAES0803USA01717
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0384U 0 IM UN
TDAP UNKNOWN MANUFACTURER   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Chlamydia serology, Drug exposure during pregnancy, Laboratory test, Smear cervix, Ultrasound scan, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a registered nurse concerning a 14 year old female with a history of excess sweating and no drug reactions/allergies who on 16-Nov-2007 was vaccinated with the first dose of GARDASIL (lot#657617/0384U). Concomitant therapy included a first dose of Tdap and RUBINUL (therapy unspecified). On 22-Feb-2008, the patient was vaccinated intramuscularly with 0.5ml of the second dose of GARDASIL (lot# 657617/0384U) and found out she is pregnant (LMP = 26-JAN-2008). On an unspecified date GC test (gonorrhea and chlamydia test) and PAP test were performed (results pending). Also, on an unspecified date the patient took urine pregnancy test. Unspecified medical attention was sought in the office. Follow-up information was received. On 09-APR-2008 an ultrasound was performed which indicated a 9 weeks 2 days pregnancy. On an unspecified date the female patient experienced spontaneous abortion. The outcome of the spontaneous abortion was unknown. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.

 

VAERS ID: 327280   Vaccination Date: 2008-07-30
Age: 25.0   Onset Date: 2008-07-30   Days later: 0
Gender: Female   Submitted: 2008-10-06
State: New York   Entered: 2008-10-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 7/8/2008); Drug hypersensitivity
Diagnostic Lab Data: Ultrasound, 07/17/08, no fetal heart beats
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0810USA00015
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0250X 1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Muscle spasms, Ultrasound scan abnormal
Write-up: Information has been received from a registered nurse, for the pregnancy registry for GARDASIL concerning a 26 year old female with drug hypersensitivity to AMOXIL who on 26-JUL-2007 was vaccinated with the first dose of GARDASIL (lot n. 657868/0523U), 0.5 mL, intramuscularly. On 30-JUL-2008, the patient was vaccinated with the second dose of GARDASIL (lot n. 0250X) 0.5 mL, intramuscularly. On 12-SEP-2008, the patient experienced cramping and bleeding. The nurse reported that the patient had a miscarriage after receiving GARDASIL. LMP occurred on 08-JUL-2008. On 17-SEP-2008, an ultrasound was done with no fetal heart beats. She "passed" the fetus on her own. The patient saw the physician. A pregnancy blood work was done but the results were not provided. Subsequently, the patient recovered on an unspecified date. Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 327527   Vaccination Date: 2008-10-06
Age: 29.0   Onset Date: 2008-10-07   Days later: 1
Gender: Female   Submitted: 2008-10-08
State: Georga   Entered: 2008-10-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: none
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: not known
Preexisting Conditions: 10 weeks pregnant
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU SANOFI PASTEUR U2784KA   IM LA
Administered by: Private     Purchased by: Private
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Miscarriage at 10 weeks gestation within 48 hours of administration
VAERS ID: 329112   Vaccination Date: 0000-00-00
Age: 26.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-10-17
State: Washington   Entered: 2008-10-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: diagnostic laboratory, FYA antibodies; serum ANA, positive, first termination; serum ANA, negative, second termination
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0810USA02664
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Antibody test, Antinuclear antibody negative, Drug exposure during pregnancy, Uterine dilation and curettage, Vaccine positive rechallenge
Write-up: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 6 weeks and 5 days from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) negative with this second termination. the patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D & C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a first spontaneous termination after the vaccination at 13 weeks from the last menstrual period. (WAES# 0810USA01794) Additional information has been requested.
VAERS ID: 329114   Vaccination Date: 0000-00-00
Age: 26.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-10-17
State: Washington   Entered: 2008-10-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: diagnostic laboratory, FYA antibodies; serum ANA, positive-first termination; serum ANA, negative-second termination
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0810USA01794
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Antibody test, Antinuclear antibody positive, Drug exposure during pregnancy, Uterine dilation and curettage, Vaccine positive rechallenge
Write-up: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 13 weeks from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) positive with the first termination. The patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D &C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a second spontaneous termination after the vaccination at 6 weeks and 5 days from the last menstrual period. (WAES# 0810USA02664). Additional information has been requested.
VAERS ID: 330257   Vaccination Date: 2007-08-06
Age: 26.0   Onset Date: 2007-08-06   Days later: 0
Gender: Female   Submitted: 2008-10-27
State: Colorado   Entered: 2008-10-28
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 6/29/2007); Anxiety; Hay fever
Diagnostic Lab Data: ultrasound, 09/13?/07 - demise from 2 weeks prior
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0708USA04844
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0929U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan abnormal
Write-up: Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse and a physician concerning a 26 year old female with anxiety and hay fever who on 06-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot # 658282/0929U). There was no concomitant medication. On 24-AUG-2007 the patient was seen in the office for pregnancy. The patient's last menstrual period was on 29-JUN-2007 (previously reported as 15-JUN-2008) and the estimated date of delivery on 21-MAR-2008. The physician reported that the patient had a miscarriage at 8 weeks and 6 days, on 29-AUG-2007. An ultrasound was done at 10 weeks, approximately on 13-Sep-2007, which showed demise from 2 weeks prior. Upon internal review, miscarriage was considered an other important medical event. Additional information is not expected.
VAERS ID: 330686   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-10-29
State: Unknown   Entered: 2008-10-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: MENACTRA
Preexisting Conditions:
CDC 'Split Type': WAES0810USA04390
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse practitioner concerning a female patient who on unspecified dates was given all three dose of GARDASIL during pregnancy. Concomitant therapy included MENACTRA. The nurse practitioner was not informed of the pregnancy until the patient was 6 months pregnant. On an unspecified date, the patient had a miscarriage. It was not sure how far into the pregnancy when the miscarriage took place. Upon internal review, the miscarriage was considered to be an other important medical event (OME). Additional information has been requested.
VAERS ID: 330692   Vaccination Date: 2008-09-30
Age: 15.0   Onset Date: 2008-09-30   Days later: 0
Gender: Female   Submitted: 2008-10-29
State: California   Entered: 2008-10-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 9/2/2008); Depression; Cold
Diagnostic Lab Data: Urine beta-human, 07/28/08, negative; Urine beta-human, 10/17/08, faint positive; Serum beta-human, 10/17/08, 126.7, positive
Previous Vaccinations:
Other Medications: MOTRIN; POLYTRIM; ZOLOFT; SUDAFED; Prenatal Vitamins (unspecified)
Preexisting Conditions: Anxiety attack; Latent tuberculosis
CDC 'Split Type': WAES0810USA03748
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0067X 1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Conjunctivitis, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received, for the Pregnancy Registry for GARDASIL (lot number #660393/0067X), from a 15 year old female with a history of anxiety attacks and latent tuberculosis infection (+PPD, negative chest X-ray) and concurrent medical condition of cold who was vaccinated with the second dose of GARDASIL on 30-SEP-2008. Other medication used during this pregnancy included MOTRIN, POLYTRIM, ZOLOFT, SUDAFED and prenatal vitamins (unspecified). It was subsequently learned that the patient was pregnant at the time. Her LMP was 02-SEP-2008. A pregnancy test was performed. On 28-JUL-2008, urine HCG test was negative. On 17-OCT-2008 urine HCG was faint positive and serum HCG was positive (126.7). The patient experienced spontaneous abortion on 22-OCT-2008. The duration from LMP to abortion was more than 7 weeks. The patient sought unspecified medical attention. Follow-up information has been received from a physician who reported that the patient received the second dose of GARDASIL On 30-SEP-2008. It was reported that the patient had history of latent tuberculosis infection and concurrent medical condition of cold. The patient took isoniazid for the treatment of tuberculosis. During this pregnancy the patient took MOTRIN, POLYTRIM drops for the treatment of conjunctivitis, ZOLOFT for the treatment of depression, SUDAFED for the treatment of cold and prenatal vitamins (unspecified). On 22-OCT-2008 the patient experienced spontaneous abortion. Upon internal review, spontaneous abortion was considered to be a other important medical event. Additional information has been requested.
VAERS ID: 331624   Vaccination Date: 2007-12-13
Age: 18.0   Onset Date: 2007-12-13   Days later: 0
Gender: Female   Submitted: 2008-11-06
State: Missouri   Entered: 2008-11-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Beta-human chorionic, 12/27/07
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Papanicolaou smear abnormal
CDC 'Split Type': WAES0802USA04171
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0928U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy
Write-up: Information has been received from a nurse for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 13-DEC-2007 was intramuscularly vaccinated with her first dose of GARDASIL (lot # 658554/0928U) and later found out she was pregnant. On 27-Dec-2007, the patient sought unspecified medical treatment with an office visit. A pregnancy test was performed and determined she was about 5-6 weeks pregnant (LMP approximately 11/17/07). No adverse events were reported. Follow-up information was received on 03-NOV-2008 from a physician indicating that the patient is a female with 0 previous pregnancies. The patient had no significant past medical history or concurrent medical conditions. In early January 2008, 7-8 weeks from her LMP, the patient had an spontaneous abortion. The products of conception were not examined. It was unknown if the fetus was normal. Upon internal review, the spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 331799   Vaccination Date: 2007-02-01
Age: 24.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-11-07
State: Unknown   Entered: 2008-11-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0810USA05365
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 24 year old female with a history of 3 live births prior to vaccination of GARDASIL, who in February 2007 (according to the patient) was vaccinated with the first dose of GARDASIL (lot number, route and injection site unknown) at a different facility, when she was 5 weeks pregnant. The patient had sought unspecified medical attention. On an unknown date she terminated her pregnancy. Subsequently, during 2007 the same patient became pregnant 3 more times and each pregnancy ended with spontaneous abortions (miscarriages) (WAES # 0811USA00647, WAES # 0811USA00648 and WAES # 0811USA00649). The patient became pregnant again and gave birth to a child in September 2008 (WAES # 0811USA00650). On 30-OCT-2008, the patient received the second dose of GARDASIL (lot number, route and injection site unknown). Upon internal review, elective abortion was considered to be other important medical event. Additional information has been requested.
VAERS ID: 331800   Vaccination Date: 2008-10-30
Age: 24.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-11-07
State: Unknown   Entered: 2008-11-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0811USA00647
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 24 year old female with a history of 3 live births prior to vaccination of GARDASIL, who in February 2007 (according to the patient) was vaccinated with the first dose of GARDASIL (lot number, route and injection site unknown) at a different facility, when she was 5 weeks pregnant. The patient sought unspecified medical attention. On an unknown date she terminated her pregnancy (WAES # 0810USA05365). Later in 2007 the patient became pregnant again, which ended with spontaneous abortion. Subsequently, during 2007 the same patient became pregnant 2 more times and each pregnancy ended with spontaneous abortions (WAES # 0811USA00648 and WAES # 0811USA00649). There were a total of 4 pregnancies in 2007 (the one that was terminated and the 3 that miscarried). Afterward, the patient became pregnant another time and gave birth to a child in September 2008 (WAES # 0811USA00650). On 30-OCT-2008, the patient received the second dose of GARDASIL (lot number, route and injection site unknown). Upon internal review, spontaneous abortion was considered to be other important medical event. Additional information has been requested.

 

VAERS ID: 331801   Vaccination Date: 2008-10-30
Age: 24.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-11-07
State: Unknown   Entered: 2008-11-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0811USA00648
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 24 year old female with a history of 3 live births prior to vaccination of GARDASIL, who in February 2007 (according to the patient) was vaccinated with the first dose of GARDASIL vaccine (lot number, route and injection site unknown) at a different facility, when she was 5 weeks pregnant. The patient sought unspecified medical attention. On an unknown date she terminated her pregnancy (WAES # 0810USA05365). Afterward the same patient became pregnant which ended with spontaneous abortion (WAES # 0811USA00647). Later in 2007 the patient became pregnant again, which ended with spontaneous abortion for the second time. Subsequently, during 2007 the same patient became pregnant 1 more time and the pregnancy also ended with spontaneous abortion (WAES # 0811USA00649). There were a total of 4 pregnancies in 2007 (the one that was terminated and the 3 that miscarried). Afterward, the patient became pregnant another time and gave birth to a child in September 2008 (WAES # 0811USA00650). On 30-OCT-2008, the patient received the second dose of GARDASIL (lot number, route and injection site unknown). Upon internal review, spontaneous abortion was considered to be other important medical event. Additional information has been requested.
VAERS ID: 331802   Vaccination Date: 2008-10-30
Age: 24.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-11-07
State: Unknown   Entered: 2008-11-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0811USA00649
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 24 year old female with a history of 3 live births prior to vaccination of GARDASIL, who in February 2007 (according to the patient) was vaccinated with the first dose of GARDASIL (lot number, route and injection site unknown) at a different facility, when she was 5 weeks pregnant. The patient sought unspecified medical attention. On an unknown date she terminated her pregnancy (WAES # 0810USA05365). Afterward the same patient became pregnant twice which ended with spontaneous abortion (WAES # 0811USA00647 and WAES # 0811USA00648). Later in 2007 the patient became pregnant again and the pregnancy ended with spontaneous abortion for the third time. There were a total of 4 pregnancies in 2007 (the one that was terminated and the 3 that miscarried). Afterward, the patient became pregnant another time and gave birth to a child in September 2008 (WAES # 0811USA00650). On 30-OCT-2008, the patient received the second dose of GARDASIL (lot number, route and injection site unknown). Upon internal review, spontaneous abortion was considered to be other important medical event. Additional information has been requested.
VAERS ID: 332018   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-11-10
State: Missouri   Entered: 2008-11-12
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0811USA00534
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a an office manager, concerning 2 to 3 female patients who on an unspecified date were vaccinated with a dose of GARDASIL, Lot number was not available. The office manager reported that there were 2 to 3 patients who had miscarriage around the time when they received GARDASIL. At the time of the report the patients' outcome was unknown. The patient sought medical attention, seen by the physician. Miscarriage was considered to be an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
VAERS ID: 332339   Vaccination Date: 2008-08-11
Age: 26.0   Onset Date: 2008-08-11   Days later: 0
Gender: Female   Submitted: 2008-11-13
State: California   Entered: 2008-11-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 8/1/2008)
Diagnostic Lab Data: beta-human chorionic, 08/11?/08, positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0809USA01840
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received for the pregnancy registry for VARIVAX from a 26 year old female registered nurse with no known pertinent medical history or drug reactions/allergies who on approximately 11-AUG-2008, "4 weeks ago," was vaccinated with a dose of VARIVAX 0.5 ml. There was no concomitant therapy. On approximately 11-AUG-2008, "4 weeks ago," the patient underwent a pregnancy test which was noted to be positive. The last menstrual period was 01-Aug-2008. The estimated due date is 08-May-2009. Follow-up information was received from the registered nurse. She had a miscarriage at 12 to 13 weeks gestational age. Upon internal review the miscarriage was considered to be an other important medical event. No further information is available.
VAERS ID: 332707   Vaccination Date: 2008-04-07
Age: 22.0   Onset Date: 2008-04-29   Days later: 22
Gender: Female   Submitted: 2008-11-18
State: Massachusetts   Entered: 2008-11-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: none
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: unknown
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL ACAMBIS, INC. VV04-003A      
Administered by: Military     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Vaccinated during pregnancy Pregnancy resulted in spontaneous abortion
VAERS ID: 332748   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-11-18
State: Unknown   Entered: 2008-11-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0811USA02218
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a female who was pregnant and vaccinated with the third dose of GARDASIL, IM, 0.5ml. Subsequently the patient had a miscarriage. This occurred some time ago and the reporter does not have patient information at this time. The patient sought unspecified medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 333704   Vaccination Date: 2008-08-26
Age: 24.0   Onset Date: 2008-09-09   Days later: 14
Gender: Female   Submitted: 2008-12-02
State: Unknown   Entered: 2008-12-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 9/9/2008)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0811USA03785
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0571X 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a 24 year old female who on 26-AUG-2008 was vaccinated with a first dose of GARDASIL (lot # 660620/0571X). There was no concomitant medication. On an unspecified date, she became pregnant. The date of last menstrual period was 09-SEP-2008. On 05-NOV-2008, approximately 7 weeks from the date of last menstrual period, the patient experienced spontaneous abortion. No product of conception was examined. Additional information has been requested.
VAERS ID: 333765   Vaccination Date: 2008-09-30
Age: 15.0   Onset Date: 2008-10-22   Days later: 22
Gender: Female   Submitted: 2008-12-03
State: California   Entered: 2008-12-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: ZOLOFT; POLYTRIMEYEDROPS; Prenatal vitamins; MOTRIN; SUDAFED
Preexisting Conditions: History of LTBI
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0067X 1 IM LA
Administered by: Other     Purchased by: Public
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: 15 year old female LMP 9/2/08 urine HCG negative 9/28/08. GARDASIL given 9/30/08. Urine HCG positive 10/17/08 with positive exam HCG(126.7) on same day. status post spontaneous abortion 10/22/08.
VAERS ID: 335489   Vaccination Date: 2008-06-01
Age: 20.0   Onset Date: 2008-07-25   Days later: 54
Gender: Female   Submitted: 2008-12-16
State: Unknown   Entered: 2008-12-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = 7/25/2008)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0812USA02338
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a licensed practical nurse concerning a 20 year old female patient who in June 2008, was vaccinated with the first dose of GARDASI, lot # was not reported. It was reported that the patient became pregnant with twins and had a miscarriage about one week ago. Patient was hospitalized. LMP was 25-JUL-2008. Additional information has been requested.
VAERS ID: 335775   Vaccination Date: 2007-11-21
Age: 18.0   Onset Date: 2008-03-03   Days later: 103
Gender: Female   Submitted: 2008-12-19
State: Texas   Entered: 2008-12-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: None
Diagnostic Lab Data: intravaginal ultrasound and HCG test
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN MEDIMMUNE VACCINES, INC. 500491P 0 IN  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Cervicitis, Chlamydial infection, Drug exposure during pregnancy, Muscle spasms, Polymerase chain reaction, Pregnancy test, Ultrasound scan vagina, Urine analysis abnormal, Vaginal discharge, Vaginal haemorrhage
Write-up: Subject 1-07-03285 is a nearly 19 year old G2P1 female who was initially seen in the emergency room on 05Feb2008 for 1 day history of sporadic vaginal bleeding with no other symptoms. Her last menstrual period was 20Dec2007. Her human chorionic gonadotropin (HCG) level was 18,638 units/ml, which is consistent with 4 to 5 weeks gestation. An ultrasound revealed an intrauterine pregnancy. Urine analysis was negative for trichomonas by wet mount but positive by PCR. Her urine analysis was also negative for yeast and positive for clue cells and moderate amount of WBC. She was diagnoses with a threatened miscarriage and was sent home for follow-up in one week. Her specimen from the cervix was reported positive on 07Feb2008 for Chlamydia trachomatis by PCR and was negative for Neisseria gonorrhoeae. Subject was again seen in the ER on 11Feb2008 for daily vaginal bleeding of approximately 1 pad/day. She complained of mild suprapubic cramping. Repeat ultrasound showed an irregular yolk sac contour and a fetal pole that was not visualized. Mean gestational sac measurement corresponded to a 7 week gestation. Her HCG increased to 20,000 units/ml. These observations were consistent with nonviable pregnancy and impending miscarriage. She was sent home and instructed to take prenatal vitamins and avoid cigarette smoke. Repeat cervical test for GC and Chlamydia was again positive for Chlamydia trachomatis by PCR. The subject was seen in the ER on 03Mar2008 for vaginal discharge irritation and for treatment of her positive Chlamydia trachomatis test. Her HCG level was 8 consisted with a nonpregnant state. An ultrasound did not reveal an intrauterine pregnancy. Subject was treated with rocephin 250 mg IM and one gram oral dose of zithromax. Final diagnosis: Complete Miscarriage Secondary: Chlamydia trachomatis cervicitis Past Medical History: none Medication: none. Date of Last Menstrual Period: 20 Dec 2007 Influenza vaccine: FluMist Date of Vaccination: 21 Nov 2007 Date of Birth: 13 Feb 1989

 

VAERS ID: 336144   Vaccination Date: 2008-09-26
Age: 32.0   Onset Date: 2008-11-26   Days later: 61
Gender: Female   Submitted: 2008-12-23
State: Maryland   Entered: 2008-12-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: SYNTHROID; CELEXA
Preexisting Conditions: The patient had a history of hypothyroidism and depression. From new information received on 22 December 2008, the patient's past obstetrical history included one previous pregnancy that resulted in one live birth with no congenital anomalies.
CDC 'Split Type': 200803104
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR C2998B   IM RA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Initial information was received from a health care professional on 08 October 2008. A 32 year old female patient with a history of depression, hypothyroidism, and one previous pregnancy resulting in a full term delivery received an intramuscular booster dose of ADACEL in the right deltoid on 26 September 2008 (lot number C2998BA). The patient was "two to five weeks pregnant". It was not reported whether the patient was two to five weeks pregnant at the time of the report or at the time of vaccination. The patient's date of her last menstrual period was unknown. The patient's estimated due date was reported as "30 June 2009 to 10 June 2009". The patient did not experience any adverse events at the time of the report. No further information was provided. Follow-up information received on 22 December 2008 from a physician. The patient has past obstetrical history of one previous pregnancy that resulted in one live birth with no congenital anomalies. The patient was reported to have miscarried, the current pregnancy on 26 November 2008 at seven weeks gestation. It was not reported whether the patient had any other adverse events since being vaccinated with ADACEL on 26 September 2008. No other information was provided. Documents held by sender: none.
VAERS ID: 352240   Vaccination Date: 2008-11-20
Age: 15.0   Onset Date: 2008-12-17   Days later: 27
Gender: Female   Submitted: 2009-07-22
State: Texas   Entered: 2009-07-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': 200903043
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU SANOFI PASTEUR U2849A   UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan vagina abnormal, Urinary tract infection, Vaginal haemorrhage
Write-up: This case was received from a health professional on 10 July 2009, and involves a subject enrolled in an investigator-sponsored study. Subject ID: 1-08-08925. A 15-year-old female subject, with a history of appendectomy, received an injection of FLUZONE SV 2008-2009 (lot number U2849AC) on 20 November 2008. At the time of vaccination, she was confirmed to be 8 weeks pregnant; date of last menstrual period was 15 September 2008. Prior to vaccination, on 16 November 2008, the subject had presented to the emergency room with complaints of spotting bright red blood and pain on urination. Physical exam revealed suprapubic tenderness and left costal-vertebral tenderness, and urine analysis was consistent with a urinary tract infection. A transvaginal ultrasound revealed a viable fetus with a fetal heart rate of 150 beats per minute. The subject was given the discharge diagnosis of healthy pregnancy with urinary tract infection, and was prescribed antibiotics. She received study vaccine on 20 November 2008. On 17 December 2008, 27 days post-vaccination, the subject presented to the hospital with a three-day history of increasing abdominal cramping and spotting. The subject reported that she had never taken the antibiotics prescribed for her urinary tract infection. A transvaginal ultrasound showed no intrauterine pregnancy. Fluid was noted in the uterus, and tissue was present at the os of the cervix. She was discharged home to follow-up with her obstetrician, and final diagnosis was complete spontaneous miscarriage. According to the reporter, the event was not related to FLUZONE. Documents held by sender: None.
VAERS ID: 352453   Vaccination Date: 2009-06-04
Age: 32.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-07-24
State: Illinois   Entered: 2009-07-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: Unk
Previous Vaccinations:
Other Medications: Blood pressure medication
Preexisting Conditions: No known adverse events were reported with previous vaccinations.
CDC 'Split Type': A0794397A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS AHABB091BA 0 UN RA
MMR MERCK & CO. INC. 0357X   IM UN
TDAP SANOFI PASTEUR C2966AA   IM UN
Administered by: Public     Purchased by: Public
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Uterine dilation and curettage, Vaginal haemorrhage
Write-up: This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 4 June 2009; ADACEL (non-gsk); Sanofi; given on 4 June 2009. Concurrent medications included Blood pressure medication. On 4 June 2009, the subject received 1st dose of TWINRIX (unknown, right arm) and experienced vaccine exposure during pregnancy. Immunization series was discontinued. The reporter stated that prior to receiving the TWINRIX vaccine; the subject was given a pregnancy test. The "line initially showed up but then went away". The subject stated that she was just about to start her period, so the vaccine was given. The subject took a pregnancy test within two to three days of receiving the TWINRIX vaccine, and the test came back positive. The reporter stated she thought the subject mentioned that she was on a blood pressure pill but she could not remember for certain, and she did not know the name of the pill. Also, with the concomitant MMR and Tdap vaccines that were give, she did not know the brand names. Follow up received from reporting healthcare professional on 20 July 2009: The subject's last menstrual period occurred on an unknown date. The conception was reported as normal. On an unknown date the subject started spotting and experienced miscarriage. This case was assessed as serious (potentially medically serious) by GSK. The subject was treated with dilation and curettage on 14 July 2009. At the time of reporting, the outcome of the events was unknown.
VAERS ID: 352472   Vaccination Date: 2009-03-01
Age: 25.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-07-24
State: California   Entered: 2009-07-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0907USA03354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no pertinent medical history who in approximately March 2009, was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). There was no concomitant medication. Subsequently the patient determined to be pregnant. The patient's menstrual period was not reported. The patient experienced a spontaneous miscarriage on an unspecified date. The patient had sought unspecified medical attention. At the time of report, the patient had recovered on an unspecified date. The physician felt that spontaneous miscarriage was not related to therapy with GARDASIL. Upon internal review, spontaneous miscarriage was considered to be an other important medical event. Additional information has been requested.
VAERS ID: 353526   Vaccination Date: 2008-02-22
Age: 32.0   Onset Date: 2008-04-01   Days later: 39
Gender: Female   Submitted: 2009-08-07
State: Washington   Entered: 2009-08-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown); Cardiac murmur
Diagnostic Lab Data: beta-human chorionic, home pregnancy test; beta-human chorionic, home pregnancy test; serum varicella zoster, 02/11/08, negative
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Abortion spontaneous
CDC 'Split Type': WAES0803USA00547
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.   0 SC UN
VARCEL MERCK & CO. INC.   0 SC UN
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test, Varicella zoster serology negative
Write-up: Information has been received for the Merck Pregnancy Registry from a physician for VARIVAX (Merck) concerning a 33 year old female with cardiac murmur and no drug reactions/allergies who on 22-FEB-2008 was vaccinated with VARIVAX (Merck) 0.5 mL subcutaneously. On 22-FEB-2008 secondary suspect therapy included MMR 0.5 mL subcutaneously. There was no other concomitant medication. The physician reported that his employee had no immunity to varicella and mumps. The patient vaccination history was not available at the time. On 03-MAR-2008 the patient stated that she was 3 weeks pregnant as per her two home pregnancy tests. Medical attention was sought. The date of the LMP was not available. The estimated date of delivery is unknown. Follow-up information has been received from the physician. In approximately April 2008, the female patient had a spontaneous abortion (approximately 8 weeks from LMP). She had a history of spontaneous abortion with her first pregnancy on an unspecified date, and she has no full term deliveries. On 11-FEB-2008, the serum varicella zoster virus antibody test result was negative. There were no other maternal adverse events during maternal period. No other information was available at the time of this report. The spontaneous abortion was considered to be an other medical important event. Additional information has been requested.
VAERS ID: 354732   Vaccination Date: 2008-04-01
Age:    Onset Date: 2008-04-01   Days later: 0
Gender: Female   Submitted: 2009-08-19
State: Arkansas   Entered: 2009-08-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP= Unknown)
Diagnostic Lab Data: urine beta-human, negative; beta-human chorionic, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0804USA01984
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Urine human chorionic gonadotropin negative
Write-up: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a female who in the first week of April 2008, was vaccinated with VARIVAX (Merck). Subsequently she became pregnant. Prior to the VARIVAX (Merck) vaccination, a urine pregnancy test was taken and was negative. Physician stated patient, who is also her friend, called her stating she took a home pregnancy test and it was positive. Physician stated that patient did not know if she will continue the pregnancy. Follow-up information was received from a nurse who stated that the patient had a miscarriage in May 2008 (about 4 weeks after vaccination of VARIVAX (Merck). The cause of miscarriage was unknown. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 356980   Vaccination Date: 2008-04-01
Age: 18.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-09-10
State: South Carolina   Entered: 2009-09-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: cervical smear, abnormal
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0909USA00783
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Smear cervix abnormal
Write-up: Information has been received from a nurse for GARDASIL, a pregnancy registry product, concerning an 18 year old female patient who in April 2008 was vaccinated with the second dose of GARDASIL. After receiving her second dose the patient became pregnant and miscarried. the last menstruation period was unspecified. She reported this to office after the event and they followed up with a Pap smear which came back normal. No lot number provided. At the time of report the patient's status was unknown. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 357015   Vaccination Date: 2009-08-13
Age: 29.0   Onset Date: 2009-08-31   Days later: 18
Gender: Female   Submitted: 2009-09-08
State: Washington   Entered: 2009-09-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Prenatal vitamins
Preexisting Conditions: No medical history, allergies, or medical conditions; no previous pregnancies.
CDC 'Split Type': 200903798
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: This spontaneous case was received from a consumer on 03 September 2009. A 29-year-old female patient, with no reported medical history and no previous pregnancies, received an injection of ADACEL (lot not reported) on 13 August 2009. She was four weeks pregnant at the time of vaccination; date of last menstrual period was not reported. On 31 August 2009, 18 days post-vaccination, the patient had a miscarriage. No additional information was provided.
VAERS ID: 357098   Vaccination Date: 2009-07-23
Age: 17.0   Onset Date: 2009-09-03   Days later: 42
Gender: Female   Submitted: 2009-09-11
State: Illinois   Entered: 2009-09-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: None
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: was not aware she was pregnant
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ SANOFI PASTEUR U2661AA 0 IM RA
Administered by: Other     Purchased by: Public
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Miscarriage Pt was not aware she was pregnant at time of vaccine Pt was 5-6 wks pregnant at time of vaccine. H/o prior miscarriage about 1 yr ago.
VAERS ID: 357132   Vaccination Date: 2008-09-17
Age: 22.0   Onset Date: 2008-10-20   Days later: 33
Gender: Female   Submitted: 2009-09-11
State: Florida   Entered: 2009-09-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 10/20/2008)
Diagnostic Lab Data: beta-human chorionic, 11/17/08, positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0811USA02648
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a 22 year old female consumer with no pertinent medical history or drug reactions or allergies, for the Pregnancy Registry for GARDASIL, who on approximately 17-SEP-2008, "about two months ago", was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On 17-NOV-2008, "today", she did a home pregnancy test and found out that she was pregnant. The LMP was 20-OCT-2008. No adverse event involved. The consumer reported that she had called her physician, but had not seen the physician as of yet. Follow-up information was received from the patient which reported that the pregnancy resulted in miscarriage after two months (on approximately 20-DEC-2008). The patient thought it was due to GARDASIL especially that "she was only 22 year old and already had one child". The patient stated that she never received her third dose. Upon internal review, miscarriage was considered to be other important medical event. The patient also reported that she recently got pregnant again (WAES # 0909USA00978). Additional information has been requested.

 

VAERS ID: 159669   Vaccination Date: 2000-07-11
Age: 33.0   Onset Date: 2000-08-16   Days later: 36
Gender: Female   Submitted: 2000-09-13
State:    Entered: 2000-09-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: pregnancy test-positive
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': 20000247291
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP SMITHKLINE BEECHAM   1 IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal
Write-up: On 6/7/00, the pt received her dose of Engerix-B, followed by the 2nd dose on 7/11/00. The vaccinee subsequently, found that she was pregnant, confirmed by a positive pregnancy test on 8/16/00. The most recent information received on 9/8/00, reports that the vaccinee spontaneously miscarried during the 10th week of gestation. The reporting doctor did not consider the events to be related to the vaccine.
VAERS ID: 171985   Vaccination Date: 2001-02-01
Age: 24.0   Onset Date: 2001-06-07   Days later: 126
Gender: Female   Submitted: 2001-06-07
State:    Entered: 2001-06-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': 20010143561
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS   1 IM  
Administered by:      Purchased by:
Symptoms: Abortion spontaneous
Write-up: In 1/01 and in 2/01, the pt received her 1st and 2nd doses of Twinrix. Reportedly, she became pregnant at the end of 3/01. This was her 1st pregnancy. She had a miscarriage on 6/7/01. This was her 1st miscarriage. Reportedly, she had not taken any medications between the end of 3/01 and the miscarriage. She did not get her 3rd dose of Twinrix. This report is considered to be "Medically Serious". As of 6/11/01, the outcome of the mother's health was not specified.
VAERS ID: 174625   Vaccination Date: 2000-10-15
Age: 27.0   Onset Date: 2000-11-02   Days later: 18
Gender: Female   Submitted: 2001-08-23
State:    Entered: 2001-08-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: pregnant
CDC 'Split Type': 29919291621
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP SMITHKLINE BEECHAM     IM  
Administered by:      Purchased by:
Symptoms: Abortion spontaneous
Write-up: This report describes the abortion in a 27 year old female subject receiving Engerix-B. On 10/15/00, a dose of Engerix-B (20 mcg IM) was given. On 11/2/00, 18 days, post vax, the subject aborted. The reporting physician considered the event to be unlikely related to Engerix-B. Additional information has been requested. F/U received on 9/28/01, states that this was her 1st dose of Engerix-B (1ml IM). At that time, she did not know she was pregnant. Her last menstrual period was on 12/7/00. On 11/2/00, 18 days post vax, the pt aborted spontaneously. The reporting physician considered the event to be possibly related to Engerix-B. No further details will be available. This case has therefore been closed. This was considered to be an "Serious Medical Term".
VAERS ID: 175293   Vaccination Date: 2001-07-13
Age:    Onset Date: 2001-08-06   Days later: 24
Gender: Male   Submitted: 2001-09-10
State:    Entered: 2001-09-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: History of previous miscarriage.
CDC 'Split Type': 20010186401
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER        
TYP UNKNOWN MANUFACTURER        
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
Write-up: This patient had a previous miscarriage. On 07/13/01, the vaccinee received a dose of Hepatyrix vaccine. The vaccinee later found out that she was pregnant at the time of vaccination. Estimated date of delivery 04/02. The most recent info received on 08/29/01 reports that the vaccinee underwent a scan on 08/06/01, which confirmed she had a miscarriage. The vaccinee's doctor considered the event to be a spontaneous abortion and it is unlikely the vaccine is implicated.
VAERS ID: 349543   Vaccination Date: 2008-10-24
Age:    Onset Date: 2009-02-01   Days later: 100
Gender: Female   Submitted: 2009-06-18
State: Unknown   Entered: 2009-06-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0906USA02049
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder
Write-up: Information has been received through the Merck pregnancy registry for GARDASIL from a registered nurse concerning a female patient who on 17-JUN-2008 and 24-OCT-2008, was vaccinated with first and second dose respectively of GARDASIL (dose, route and lot number not reported). The registered nurse reported that the patient found out that she was pregnant in February 2009, but "the baby stopped growing at 10 weeks" and she lost her pregnancy in March 2009. It was reported that the patient waited for one month following the loss and had became pregnant again (WAES 0906USA02053). The registered nurse reported that the patient was not pregnant at the time of her previous two vaccinations. Upon internal review, the baby stopped growing at 10 weeks and she lost her pregnancy were determined to be other important medical events. This is one of two reports regarding the same patient. Additional information has been requested.
VAERS ID: 349805   Vaccination Date: 2009-02-01
Age: 21.0   Onset Date: 2009-02-01   Days later: 0
Gender: Female   Submitted: 2009-06-22
State: Unknown   Entered: 2009-06-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: beta-human chorionic, result negative
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: Miscarriage; Anaemia
CDC 'Split Type': WAES0906USA02881
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Anaemia, Blood test, Condition aggravated, Drug exposure during pregnancy, Pregnancy test negative, Uterine dilation and curettage
Write-up: Information has been received from a 21 year old female patient with a history of previous miscarriage and anaemia who in February 2009, was vaccinated with the first dose of GARDASIL (lot# not available). There was no concomitant medication. The Health Department that administered the vaccine did a pregnancy test but it came back negative. The patient thinks she may have been about 2 weeks pregnant at the time of the injection. On 07-MAY-2009 the patient had a miscarriage and the physician also discovered she had an anemia. A blood test and "D & C" (unspecified) were performed (no results provided). The patient sought unspecified medical attention. Upon internal review miscarriage was considered to be another important medical event. No further information is available.
VAERS ID: 350093   Vaccination Date: 2008-03-19
Age: 16.0   Onset Date: 2008-03-19   Days later: 0
Gender: Female   Submitted: 2009-06-24
State: North Carolina   Entered: 2009-06-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 2/25/2008)
Diagnostic Lab Data: beta-human chorionic, 03/19/08, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0803USA03943
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Uterine dilation and curettage
Write-up: Information has been received from a 16 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself who on 19-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). On the same day the patient had a positive pregnancy test in the office. Her estimated LMP was 25-FEB-2008. She sought unspecified medical attention. Follow-up information received on 13-JAN-2009 from a woman from a doctor's office indicated that they did not follow up with the patient after she became pregnant. The reporter provided the OB/GYN practice information. Follow-up information was received from a person from the doctor's office indicating that the patient had a miscarriage in early pregnancy and had a dilation and curettage on 25-MAY-2008. It was also reported that the patient did not receive GARDASIL in their office. Upon internal review, miscarriage was determined to be an important medical event. Additional information has been requested.
VAERS ID: 350603   Vaccination Date: 2008-06-17
Age: 26.0   Onset Date: 2008-08-26   Days later: 70
Gender: Female   Submitted: 2009-06-30
State: Unknown   Entered: 2009-07-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 8/26/2008)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: hormonal contraceptives
Preexisting Conditions:
CDC 'Split Type': WAES0810USA00881
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1740U 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug administered at inappropriate site, Drug exposure during pregnancy
Write-up: Information has been received from a Certified Medical Assistant (C.M.A.), for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who on 17-JUN-2008 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 659962/1740U) in the left arm and on 22-SEP-2008 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 660620/0571X) in the right hip. Concomitant therapy included hormonal contraceptives (unspecified). The patient became pregnant before the GARDASIL series had been completed. No adverse symptoms. It was reported that the last menstrual period (LMP) was 26-AUG-2008. Medical attention was sought via phone call. No product quality complaint was involved. Follow-up information was received from the nurse practitioner. The nurse reported that the patient had not received any concomitant vaccines when she received the first two doses of GARDASIL. The patient had not received the third dose of GARDASIL. The patient had a miscarriage sometime between August 2008 and December 2008. The patient had recovered from the miscarriage. The patient's last menstrual period (LMP) was also reported as 14-DEC-2008. Additional information has been requested.
VAERS ID: 351715   Vaccination Date: 2008-05-19
Age: 26.0   Onset Date: 2008-07-01   Days later: 43
Gender: Female   Submitted: 2009-07-16
State: Maryland   Entered: 2009-07-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 7/1/2008); Allergic reaction to antibiotics
Diagnostic Lab Data: urine beta-human, positive; serum beta-human, positive
Previous Vaccinations:
Other Medications: MOTRIN; vitamins (unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0808USA04839
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1968U 1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Urine human chorionic gonadotropin positive
Write-up: Information has been received for the pregnancy registry for GARDASIL from a master of science in nursing concerning a 26 year old female with no pertinent medical history and allergy to erythromycin who on 24-MAR-2008 was vaccinated with the first 0.5mL dose of GARDASIL IM (Lot No. 655604/0052X) and on 19-MAY-2008 was vaccinated with the second 0.5mL dose of GARDASIL IM (Lot No. 660389/1968U). Concomitant therapy included MOTRIN and vitamins (unspecified). The patient received her first two doses of GARDASIL and is now pregnant. The patient sought medical attention, seen by the practice. The last menstrual period was on 01-JUL-2008. On an unspecified date, was performed a urine pregnancy test and a serum pregnancy test resulting positive. Estimated date of delivery approximately on 07-APR-2009. The patient has not experienced any known symptoms. Follow up information has been received from a case manager in the office, concerning a 26 year old female who on 17-FEB-2009 "lost" the baby. However, the mother is fine. The office hasn't really followed her and doesn't have much more information. Upon internal review: the patient "lost" her baby, was considered as other important medical event. No further information is available.
VAERS ID: 351864   Vaccination Date: 2008-09-24
Age: 16.0   Onset Date: 2008-09-24   Days later: 0
Gender: Female   Submitted: 2009-07-17
State: Michigan   Entered: 2009-07-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 8/29/2008)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0810USA02010
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0570X 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 16 year old female who on 24-SEP-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM. Subsequently, the patient was found to be pregnant. On 10-OCT-2008 the patient was 6 weeks gestation. The last menstrual period was approximately 29-Aug-2008. The estimated due date is 05-Jun-2009. The patient sought medical attention by calling the nurse. Follow-up information was received from another registered nurse who reported that the patient was vaccinated with a first dose of GARDASIL (lot# 660616/0570X) 0.5 ml IM on 24-SEP-2008. Concomitant therapy included prenatal vitamins (unspecified). At the end of September 2008 or beginning of October 2008, the patient underwent a routine ultrasound without result provided. At the end of November 2008, after Thanksgiving, the patient experienced spontaneous abortion (less than 20 weeks). The outcome of the patient was not reported. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.

 

VAERS ID: 175717   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2001-09-24
State:    Entered: 2001-09-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': 20010222341
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS   1 IM  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
Write-up: This report describes the occurrence of a pregnancy, miscarriage in a female pt of unknown age receiving Twinrix Adult. The pt received the 2nd dose of Twinrix Adult. As of 8/16/01, at the time of this report, she was pregnant. At about 8 weeks of pregnancy, the subject miscarried. The reporting physcian advised that the possibility of the vaccine being the cause of the subject's miscarriage never entered his mind
VAERS ID: 176435   Vaccination Date: 2001-08-16
Age: 29.0   Onset Date: 2001-09-02   Days later: 17
Gender: Female   Submitted: 2001-10-09
State:    Entered: 2001-10-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': 20010205721
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER (A)   IM  
TYP UNKNOWN MANUFACTURER (B)   IM  
Administered by:      Purchased by:
Symptoms: Abortion spontaneous
Write-up: On 8/16/2001, the pt received a dose of Hepatyrix. The vaccinee then discovered that she was pregnant. The pregnancy was unexpected and the pt may decide not to keep the baby, not necessarily because of vaccination. The most recent information received on 10/2/01, reports that the pt experienced a miscarriage on 9/2/01. Evacuation of retained products of conception was performed. The reporter was uncertain as to whether the miscarriage was due to vaccination.
VAERS ID: 210271   Vaccination Date: 2003-08-29
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2003-10-09
State:    Entered: 2003-10-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Miscarriage- history of frequent miscarriages
CDC 'Split Type': B0309441A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS        
RAB UNKNOWN MANUFACTURER        
TD UNKNOWN MANUFACTURER        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: This case was reported by a other health professional and described the occurrence of miscarriage in a female pt who had Poliomyelitis vaccine. Co-suspect medication included Twinrix. Concurrent medications included Rabies vaccine and Diphtheria + tetanus vaccine. Medical history of frequent miscarriages. On 8/29/03 the pt received Poliomyelitis vaccine and Twinrix vaccine as she was planning a holiday. The pt subsequently found out she was 5 weeks pregnant when she had the vaccination. On an unknown date, the pt had a miscarriage. The miscarriage was believed to be due to perforated uterus following surgery. The miscarriage was believed to be unrelated to the polio vaccine. The event resolved.
VAERS ID: 211165   Vaccination Date: 2002-08-09
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2003-10-28
State:    Entered: 2003-10-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0277976A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: This report received from the pt herself who is a nurse describes the occurrence of miscarriage in a female subject of unknown age receiving Hepatitis B (Engerix B) for prophylaxis. LMP is 07/16/2002. Estimated delivery date is end April or start of May 2003. On 08/09/2002, the subject received a dose of Engerix B. At that time she thought she was not pregnant. On 08/21/2002, a pregnancy test was performed and showed to be positive. At 10 weeks of gestation, she experienced a miscarriage. Then she became pregnant again and at 6 weeks of gestation she miscarried once more. As of 10/15/2003, at the time of the follow-up report, she is pregnant for the 3rd time and is at 36 weeks of gestation. Additional info has been requested.
VAERS ID: 211167   Vaccination Date: 2003-09-05
Age: 30.0   Onset Date: 2003-09-18   Days later: 13
Gender: Female   Submitted: 2003-10-28
State:    Entered: 2003-10-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0312023A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS 273D6   IM  
RAB UNKNOWN MANUFACTURER 325011   IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: This case was reported by a regulatory authority and described the occurrence of miscarriage in a 30 year old female patient who received Twinrix injection. Co-suspect medication included Typherix and Poliomyelitis vaccine oral. Concurrent medications included Rabipur and Diphtheria toxoid. The patient had stated that she was not pregnant before the vaccinations were received. On 8/27/03 the patient received Typherix 0.5ml and Poliomyelitis vaccine oral 0.135ml. Two days later on 8/29/03 the patient received an unknown dose of Twinrix and Rabipur. On 9/5/03 the patient received a single 1 ml dose of Twinrix (IM). On 9/15/03 the patient found out that she had been five weeks pregnant. on 9/19/03, the patient experienced a miscarriage. The event was resolved on 9/19/03. This case was considered medically serious by a manufacturer safety physician (OMIC).
VAERS ID: 211714   Vaccination Date: 2003-09-05
Age: 30.0   Onset Date: 2003-09-18   Days later: 13
Gender: Female   Submitted: 2003-10-31
State:    Entered: 2003-11-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Pregnancy
CDC 'Split Type': MA20030651
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS     IM  
RAB CHIRON CORPORATION 325011   IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: A 30 year old woman was vaccinated with 1ml Rabipur (325011) IM on 9/5/03. Additionally she received 05ml diphtheria toxoid IM, 0.135ml virus poliomyelitis oral 0.5ml Typherix vaccine IM on 8/27/03 and 1ml Twinrix vaccine IM on 9/5/03. Prior to the vaccination being given, the pt was asked and she denied being pregnant. On 9/15/03 it was found out that the pt was 5/40 pregnant. A miscarriage was reported on 9/19/03. Vaccination history: Rabipur and Twinrix vaccine were given on 8/29/03. Seriousness criterion: medically significant (OMIC).
VAERS ID: 215224   Vaccination Date: 2003-10-07
Age: 30.0   Onset Date: 2003-11-10   Days later: 34
Gender: Female   Submitted: 0000-00-00
State:    Entered: 2004-01-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Concomitant drugs not reported.
Preexisting Conditions:
CDC 'Split Type': 200400057
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU EVANS VACCINES     IM  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
Write-up: An Anonymised Single Patient Print (ASPP) report was received from a regulatory authority on 01/05/2004, concerning a 30-year-old female pt who miscarried approximately 1 month after receiving Fluvirin on 10/07/2003. On 11/10/2003 the pt miscarried. The pt had a positive pregnancy test on 10/29/2003. There was insufficient info to determine the reporter's causality. This case is suspected to be a duplicate of case PJP-2003-00904, previously reported on 12/22/2003. We await confirmation as to whether or not this case is a duplicate.
VAERS ID: 217136   Vaccination Date: 2003-02-11
Age: 37.0   Onset Date: 2003-03-21   Days later: 38
Gender: Female   Submitted: 2004-03-01
State:    Entered: 2004-03-03
Life Threatening Illness? No
Died? No
Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Pregnancy test positive
Previous Vaccinations:
Other Medications: Malarone
Preexisting Conditions: Malignant breast lump removal; In vitro fertilization; Endometriosis
CDC 'Split Type': E200400536
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER        
TD AVENTIS PASTEUR U1378   IM  
TYP AVENTIS PASTEUR     IM  
YF UNKNOWN MANUFACTURER 761313   IM  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: A 37 year old female patient received the following vaccinations on 2/11/03: Typhoid, Typhim Vi batch U1216, 25mcg, IM; Diphtheria tetanus, Diftavax batch U1378-1, 0.5mg, IM; Hepatitis A, Avaxim, batch and dose not reported, IM; Yellow fever, Arilvax batch 761313, 0.5mg, IM. She was on concomitant medication of oral Malarone between 2/3/03 and 3/19/03. She experienced a miscarriage on 3/21/03. The reaction text states: the vaccinee had a miscarriage, which was considered disabling. Miscarriage began on 3/21/03 and ended on an unspecified day. Vaccinee went to hospital as a day case for management including a scan. LMP Date was 9/2/03, therefore vaccines likely to have been given prior to conception. No further data are expected. Case is closed. (OMIC)
VAERS ID: 217548   Vaccination Date: 2004-01-14
Age: 18.0   Onset Date: 2004-02-16   Days later: 33
Gender: Female   Submitted: 2004-03-09
State:    Entered: 2004-03-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: UNK
CDC 'Split Type': D0043034A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS     IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: This case was received from a physician and was a report of miscarriage in an 18 year old female subject who was vaccinated with hepatitis B vaccine for prophylaxis. No current medical conditions and no concurrent medications were reported. On 1/14/04, the subject received the third dose of hepatitis B vaccine, IM. The subject was pregnant at this time. Estimated date of delivery was in August 2004. The subject had a miscarriage and abrasion approximately one month post vaccination, on 2/16/04. The reporter considered that the event was possibly related to the vaccination. This case was assessed as medically serious by the safety physician (OMIC). Follow up on 03/22/04 states: "The reporter considered that the event was possibly related to the vaccination. This case was assessed as medically serious by the manufacturer physician."
VAERS ID: 218424   Vaccination Date: 2003-12-19
Age: 22.0   Onset Date: 2004-02-25   Days later: 68
Gender: Female   Submitted: 2004-12-06
State:    Entered: 2004-04-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Malarone 24 tablets 1/2/04
Preexisting Conditions: Pregant LMP: 12/14/03 No previous pregnancies. Stamaril, Avaxim, and Typhim were all primary doses, Rubella vaccine was a booster. No reaction is reported following previous rubella vaccination.
CDC 'Split Type': E200400296
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER W0834      
TYP AVENTIS PASTEUR U1451      
YF AVENTIS PASTEUR W6154      
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: A 21 year old female pt received vaccines for yellow fever Stamaril W6154-3, hep A Havrix, W0834-1, and typhoid Typhim Vi U1451-1 all on 12/19/03. She also commenced 24 tablets of Malarone on 1/2/04. Vaccines were given as prophylaxis for travel. Pt was advised not to become pregnant, but was found to be pregnant. LMP date was 12/14/03 and vaccines were given only 5 days later. It is therefore possible that this lady conceived soon after vaccines were given. She had not had any previous pregnancies. The case will be followed up. Follow up 3/24/04 the company were telephoned and informed that the pt had experienced a miscarriage (no details were provided). As they had lost the pregnancy follow up form, an additional one with an adverse reaction reporting form will be sent to establish more specific details. Follow up 2APR2004: It was reported that the patient received Stamaril into her left delotid, Avaxia into her right deltoid (back) and typhim vi into her right deltoid (front) on 19DEC03, these were all primary doses and were administered intramuscularly. The patient also received a booster dose of rubella vaccine intramuscularly into her left arm on 4NOV04. The patient experienced a spontaneous abortion on 25FEB2004. The patient has been advised not to get pregnant for 2 months. No further information is expected. Case to be considered as closed. Follow up 6/14/04: Additional information confirms patient commenced a course of 24 malarone tablets on 1/2/04. Stamaril, Avaxim and Typhim were all primary doses, Rubella vaccine was a booster. No reaction is reported following previous rubella vaccination. No previous pregnancies. Case closed.

 

VAERS ID: 223781   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2004-07-08
State:    Entered: 2004-07-09
Life Threatening Illness? Yes
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0337459A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous
Write-up: This case was reported by a nurse and a physician and described the occurrence of miscarriage in a female subject of unspecified age who received hepatitis A and hepatitis B (Twinrix) injection for prophylaxis. The subject received Twinrix vaccination. At an unknown time following vaccination, the subject experienced miscarriage. The event was serious (life threatening). As of 10-Jun-04, at the time of this report, the outcome of the event was unknown. Further information requested. Follow up on 07/19/04 states: "The subject received a dose of Twinrix without knowing that she was pregnant. On an unspecified date, she experienced bleeding and low HCG level and a diagnosis of miscarriage was done by the general practitioner. On 07/14/04, a fax from the representative stated that the pt is indeed still pregnant after visiting her obstetrician. Further information has been requested."
VAERS ID: 226773   Vaccination Date: 2004-01-29
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2004-09-17
State:    Entered: 2004-09-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0321818A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS     IM  
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Medication error
Write-up: This case was reported by a practice nurse and described the occurrence of miscarriage in a female subject who received hepatitis B vaccine (Engerix B). On the 1/29/04, the subject received a dose of hepatitis B vaccine during pregnancy. The subject experienced a spontaneous miscarriage at 10-12 weeks of pregnancy. This case was considered serious (OMIC).
VAERS ID: 228825   Vaccination Date: 2002-11-26
Age: 32.0   Onset Date: 2004-07-18   Days later: 600
Gender: Female   Submitted: 2004-11-04
State:    Entered: 2004-11-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, days
    Extended hospital stay? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: Proguanil hydrochloride
Preexisting Conditions: Cesarean section; Congenital unilateral kidney;
CDC 'Split Type': B0349351A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS       UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Uterine rupture
Write-up: This case was reported by the authorities and described the occurrence of intra uterine death in a 32 year old female subject who received Hep A vaccine (Havrix) injection for prophylaxis. This subject was born with just one kidney and one ovary. Her two previous deliveries were by cesarean section due to breech presentation and oligohydramnios respectively. Concurrent medications included Paludrine. On 26Nov02, the subject received a dose of Havrix at the gestational age of 5 weeks. She also received Paludrine as malaria prophylaxis at the gestational age of 7-10 weeks. She was planned for a cesarean section. At the gestational age of 38+4 week the subject reported that the fetus movements had decreased during the last weeks. Intrauterine fetus death was stated. The subject was hospitalized. An induction was planned but in gestation week 38+6 an acute section was performed due to uterus rupture. The child and placenta lay at that time in the abdomen. Following hospitalization, the subject has completely recovered. A patho-anathomical diagnosis of the placenta was performed: older intravenous trombosis ca 5%, older infarctions, macro and micro morphologic picture as at ablation. An autopsy of the fetus was performed: severe macerated nutolytic girl, increased brain/hepatic weight quote gives suspicions of asymmetric growth inhibition. Deviant globular skull form and dysmorphic features with conspicuous tongue, ventrical septum defect, pulmonary hypoplasia, suspicions of chromosome deviancy. The diagnosis of placenta separation of the intrauterine death was considered as probable cause and placenta insufficiency as possible cause.
VAERS ID: 229652   Vaccination Date: 2004-06-18
Age: 38.0   Onset Date: 2004-09-01   Days later: 75
Gender: Female   Submitted: 2004-11-24
State:    Entered: 2004-11-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0347456A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy
Write-up: This prospective case was reported by a general practitioner and described the occurrence of spontaneous abortion in a 38 year old female pt who received Malarone tablets over a period of five days. Co-suspect medication included hepatitis A vaccine. Concurrent medications included yellow fever vaccine (Stamaril). On 18 June 2004, the pt received hepatitis A vaccine. On 5 July 2004, the pt discovered she was pregnant. The date of her last menstrual period and the estimated date of delivery were unknown. On 13 August 2004 the pt started Malarone at unknown dosing. Treatment with Malarone was discontinued on 17 August 2004. the reporter noted that the pregnancy did not proceed normally and in September 2004, the pt experienced a spontaneous abortion. The reporting general practitioner considered the event was possibly related to treatment with Malarone but unrelated to hepatitis A vaccine. This case was assessed as medically serious (OMIC) by the manufacturer.
VAERS ID: 233578   Vaccination Date: 2004-12-16
Age: 26.0   Onset Date: 2005-01-22   Days later: 37
Gender: Female   Submitted: 2005-02-09
State:    Entered: 2005-02-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: Pregnancy test 26Jan05 Positive, Pregnancy test urine 26Jan05 equivocal. Diagnostic results: The subject reported that a pelvic ultrasound was performed (date unspecified). Results of the pelvic ultrasound were not available at the time of
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Subject reported sexual abstinence since June2004. Her menstrual periods were reported to be on 27Nov04 and 12Dec04.
CDC 'Split Type': A0542924A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 25 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia associated with human papilloma virus (HPV) 16 and/or HPV18 in healthy young females. The subject reported sexual abstinence since June 2004; however, upon follow up, the subject reported that she had initiated sexual activity before the event of spontaneous complete miscarriage. Her menstrual periods were reported to be on 27Nov04 and 12Dec04 (last menstrual period). On 16Dec04, the subject received the first dose of IM injection of blinded study vaccine in the left deltoid. Lot number was not provided. The subject had been randomized to received the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hep A antigen and 500ug Al (OH) 3. On 22Jan05, 37 days after the 1st dose of investigational product, this 25 year old subject experienced vaginal bleeding and a spontaneous complete miscarriage which was clinically significant. On 26Jan05, the reported the vaginal bleeding which started on 22Jan05. She had not previously reported this to a physician. The subject's urine pregnancy test was equivocal. On the same day, she was referred to the local clinic where a blood pregnancy test was positive. This was reported to be the subject's first pregnancy. She was not admitted to the local hospital for evaluation. She was diagnosed with spontaneous complete miscarriage. She was not admitted to the hospital and no surgical procedure was performed. Upon follow up, the subject reported that a pelvic ultrasound was performed (date unspecified). Results of the pelvic ultrasound were not available at the time of reporting. At the time of reporting, she reported slight bleeding. Upon follow up, the subject was currently asymptomatic, without bleeding. As a result of this event, she was not to received investigational product in the future. The event was unresolved at time of reporting. The investigator reported the spontaneous complete miscarriage as po
VAERS ID: 235464   Vaccination Date: 2005-01-31
Age: 30.0   Onset Date: 2005-01-31   Days later: 0
Gender: Female   Submitted: 2005-03-23
State:    Entered: 2005-03-28
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Beta human chorionic gonadotropin (unsp): pregnant
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy NOS (LMP unk)
CDC 'Split Type': WAES0503USA03286
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP MERCK & CO. INC. 6488750291P      
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy
Write-up: Information has been received from a health professional concerning an adult pregnant female, with no medical history, who on 1/31/05 was vaccinatd with a first dose of hepatitis B virus vaccine. The patient's LMP was the previous week. When the patient returned for the second dose of hepatitis B virus vaccine she advised the reporter that she had experienced a miscarriage the previous week. At the time, the miscarriage occurred, the patient was in week 6 of pregnancy. Following this, the patient received the second dose of the vaccine. The reporter commented that she did not think the miscarriage was related to the vaccine. Other business partner numbers include: E200501094. This case will be followed up. (OMIC)
VAERS ID: 236882   Vaccination Date: 2004-05-12
Age: 40.0   Onset Date: 2004-06-17   Days later: 36
Gender: Female   Submitted: 2005-05-02
State:    Entered: 2005-05-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Pregnant: LMP date: 25Apr04 Sex: Female. Pt had 4 complicated pregnancies which resulted in three spontaneous abortions and one normal birth.
CDC 'Split Type': E200401832
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER X0133      
IPV AVENTIS PASTEUR S127JC      
TYP AVENTIS PASTEUR W1532      
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy
Write-up: A 40 year old female patient received first dose of hepatitis A vaccine, batch X0133-2, and typhoid vaccine, Typhim Vi batch W1532-1, and booster dose of Oral Polio Vaccine batch S127JC, all given on 5/12/04. After which, she returned to surgery on 6/8/04 and mentioned to nurse that she was pregnant. She believes that she may have conceived on 5/9/04, three days prior to vaccination. Therefore within the first week of pregnancy. Pregnancy outcome will be followed up. Follow up received on 4/26/05. On the 6/17/04, 36 days (5 weeks) after the vaccinations, the patient experienced a spontaneous complete miscarriage, the patient was five weeks pregnant. It was reported that her last menstrual period was 4/25/04. The date of conception was confirmed as 5/9/04. The patient had 4 complicated previous pregnancies which resulted in three spontaneous abortions and one normal birth. No further information is expected. Case closed. (OMIC)
VAERS ID: 237195   Vaccination Date: 2005-01-04
Age: 30.0   Onset Date: 2005-03-17   Days later: 72
Gender: Female   Submitted: 2005-05-10
State:    Entered: 2005-05-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Normal pregnancy
Diagnostic Lab Data: Scan NOS abnormal
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0379625A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS        
IPV UNKNOWN MANUFACTURER        
TD UNKNOWN MANUFACTURER        
TYP UNKNOWN MANUFACTURER        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal, Medication error, Unintended pregnancy
Write-up: This case was reported by a regulatory authority and described the occurrence of miscarriage of pregnancy in a 30 year old female subject who was vaccinated with hepatitis A and polysaccharide typhoid vaccine (Hepatyrix) for prophylaxis. Concurrent medical conditions included normal pregnancy. Concurrent medications included Revaxis. On 04 January 2005 the subject received unspecified dose of Hepatyrix. The pt conceived on the same day. A scan taken at 12 weeks showed fetal pole aged 8 weeks without heart beat. On 17 March 2005, 72 days after vaccination with Hepatyrix, the subject experienced miscarriage of pregnancy. The regulatory authority reported that the event was clinically significant (OMIC) or requiring intervention.
VAERS ID: 240919   Vaccination Date: 2005-04-26
Age: 20.0   Onset Date: 2005-06-15   Days later: 50
Gender: Female   Submitted: 2005-07-01
State:    Entered: 2005-07-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, days
    Extended hospital stay? No
Current Illness: UNK
Diagnostic Lab Data: 26May05: Pregnancy test was positive; 17Jun05: Sonogram was performed and revealed incomplete miscarriage; 18Jun05: Dilation and curettage was performed without complications.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Subject had history of regular menstrual cycles. Subject's birth control method was condoms.
CDC 'Split Type': A0560638A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 20 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia II associated with human papilloma virus (HPV)-16 and/or HPV-18 in healthy females. On 4/26/05, the subject received the first dose of IM injection of blinded study vaccine. Site of injection was the left deltoid. The lot number was not provided. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500uh Al(OH)3. On 4/16/05, the subject had her last menstrual period. A pregnancy test was found to be positive on 5/26/05 and she was referred to a local clinic to start prenatal care. Estimated date of delivery was 1/24/06. On 6/15/05, 50 days after receiving the first dose of investigational product, the subject developed moderate vaginal bleeding and pelvic pain. She consulted with the local clinic where she was prescribed rest and suppositories for pain. When the symptoms persisted, she consulted with the local clinic again and was given the same indications. On 6/17/05, a sonogram was performed and it revealed an incomplete miscarriage. She was hospitalized and underwent dilation and curettage on 6/16/05 without any complications. On 6/19/05, the event resolved and she was discharged. At the time of reporting, she was in good health. As a result of the event, the subject was to continue the study, but was not to receive any more doses of investigational product. The investigator reported the incomplete miscarriage as possibly related to treatment with investigational product due to the time between the vaccination and the moment the event occurred.
VAERS ID: 243800   Vaccination Date: 2005-08-04
Age: 29.0   Onset Date: 2005-08-04   Days later: 0
Gender: Female   Submitted: 2005-08-31
State:    Entered: 2005-09-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0508CAN00031
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.     IM  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Condition aggravated, Unintended pregnancy
Write-up: Information has been received from a physician concerning a 29 yr old female with a history of miscarriage who on 04Aug05 was vaccinated IM with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The pt was unaware she was 4 wks pregnant. On 16Aug05, 11 days after vaccination with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), the pt experienced miscarriage. The physician felt uncertain that miscarriage was related to therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Upon internal review, miscarriage was considered to be other important medical event (OMIC). No further information is available.

 

VAERS ID: 249031   Vaccination Date: 2005-10-25
Age: 18.0   Onset Date: 2005-10-25   Days later: 0
Gender: Female   Submitted: 2005-12-06
State:    Entered: 2005-12-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Insulatard (insulin human, Isophane)
Preexisting Conditions: Phantom pregnancy
CDC 'Split Type': WAES0511USA03922
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU UNKNOWN MANUFACTURER UNK     UN
PPV MERCK & CO. INC. 1128P     UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
Write-up: Information had been received from a health professional concerning a 18 year old female with a history of a phantom pregnancy who on Oct 25 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650914/1128P), batch # NB14100). Suspect vaccination on the same day included a dose of influenza virus sAg 3v vaccine inactivated (Agrippal). Concomitant medication on Nov 2 2005 included insulin human, isophane (insulatard). On Nov 17 2005, the patient received insulin aspart (Novorapid). Following vaccination, the patient discovered she was pregnant. Her LMP was Sept 17 2005, therefore it was in approximately week four of pregnancy at the time of vaccination. The patient did not experience any adverse events following vaccination. Follow up information indicated that on Nov 24 2005, the patient experienced a spontaneous abortion. Spontaneous abortion was considered to be an other important medical event (OMIC). File to be completed. Other business partner numbers included E200504600.
VAERS ID: 249983   Vaccination Date: 2005-11-13
Age: 18.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2006-01-03
State:    Entered: 2006-01-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0402636A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU GLAXOSMITHKLINE BIOLOGICALS U1202   SC UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: This case was reported by a physician and was a prospective case of pregnancy in a 18 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On Nov 13 2005 the subject, who was two weeks pregnant, received unspecified dose of Fluarix (subcutaneous). The last menstrual period and estimated date of delivery were not reported. At the time of reporting, the subject was 6 weeks into her pregnancy. Verbatim text: The subject received Fluarix four weeks ago. At the time she was 2 weeks pregnant but was unaware of this. On Follow up received Dec 20 2005, it was reported that the subject had a complete miscarriage 22 days later, on Dec 5 2005. the subject's last menstrual period occurred on Oct 13 2005. The subjects estimated date of delivery was July 21 2006. This case was considered serious by manufacturer (OMIC).
VAERS ID: 250996   Vaccination Date: 2005-11-28
Age:    Onset Date: 2005-12-10   Days later: 12
Gender: Female   Submitted: 2006-01-26
State:    Entered: 2006-01-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0601CAN00144
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.        
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy
Write-up: Information has been received from a female with a history of 5 pregnancies and 1 live birth and a history of 4 miscarriages who on 28-Nov-2005 was vaccinated with varicella virus vaccine live . On 10-Dec-2005 the patient became pregnant. On 21-Jan-2006 the patient experienced miscarriage. The patient felt that miscarriage was not related to therapy with varicella virus vaccine live. Upon internal review, miscarriage was considered to be other important medical event (OMIC). Additional information has been requested.
VAERS ID: 251850   Vaccination Date: 2006-01-10
Age: 23.0   Onset Date: 2006-02-11   Days later: 32
Gender: Female   Submitted: 2006-02-24
State:    Entered: 2006-02-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Antenatal sonogram 11Feb2006 abnormal;Antenatal sonogram 16Feb2006 abnormal
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0412596A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Foetal disorder, Laboratory test abnormal, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 23 year old female subject was enrolled in a blinded study (580299 009) for the prophylaxis of cervical intraepithelial neoplasia (CINII) associated with human papilloma virus (HPV) - 16 and/or HPV-18 in healthy young females. The subject received intramuscular investigational product single dose on 01 August 2005, 01 September 2005 and on 10 January 2006 following previous negative pregnancy test. Site of injection was the left deltoid. On 01 August 2005, 01 September 2005 and on 10 January 2006, the subject received the 1st, 2nd and 3rd intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug Al(OH)3. Lot number was not provided. On 11 February 2006, 32 days after the 3rd dose of blinded vaccine, this 23 year old subject developed pelvic pain (like contractions) and light vaginal bleeding after 9 weeks of pregnancy (her last menstrual period occurred on 15 December 2005, estimated date of deliver was 30 Septermber 2006). The subject was exposed to the vaccine during first trimester of pregnancy or before conception. She consulted a gynecologist who performed a sonogram which did not document fetal heart activity. On 16 February 2006, an other sonogram documented a missed miscarriage and she was referred to the local hospital for dilatation and curettage. She was recommended to follow medical indications and consult the hospital. On 17 February 2006, at time of last reporting, the event was unresolved. This event has been considered to be medically important (OMIC). The investigator reported the missed abortion as possibly related to investigational product due to the temporal association between the last vaccination dose administration and the onset of the event.
VAERS ID: 253346   Vaccination Date: 2005-10-25
Age: 22.0   Onset Date: 2006-02-05   Days later: 103
Gender: Female   Submitted: 2006-03-27
State:    Entered: 2006-03-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Oral contraceptive
Preexisting Conditions: Urinary Tract Infection
CDC 'Split Type': B0416291A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Urinary tract infection, Vaginal haemorrhage
Write-up: This 22 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia associated with human papillomavirus - 16 and/or HPV-18 in healthy young females. On 9/22/05 and on 10/25/05, the subject received the first and second IM injection of blinded study vaccine in the left deltoid after negative urine pregnancy tests. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500ug Al (OH)3. Lot number was not provided. Medical history: The subject has a medical history of regular menstrual cycles of 28 days. She used oral contraceptives. She experienced urinary tract infection from 1/20/06 to 2/3/06. On 2/5/06, 103 days after the second dose of Blinded vaccine, this 22 year old subject experienced light vaginal bleeding associated to the sensation of clot expulsion for which she consulted the emergency room of the local hospital, where fetal heart was auscultated. (Last menstrual period: 11/25/05; the subject was exposed to the vaccine before conception). The doctor recommended to admit her, but she did not accept because of lack of time. She continued presenting vaginal bleeding and on 2/10/06, she consulted the doctor who performed a sonogram that did not show the fetus. On the same day, she was referred to the local hospital and was hospitalized. The subject was diagnosed as having spontaneous incomplete miscarriage. On 2/11/06, she underwent dilation and curettage. The event resolved on 2/12/06 and she was discharged. The investigator reported the abortion spontaneous incomplete as possibly related to investigational product based on the temporal association between vaccination, the date of last menses and the occurrence of the SAE. She will continue in the study but will not receive the third dose.
VAERS ID: 253506   Vaccination Date: 2005-10-21
Age: 20.0   Onset Date: 2006-03-09   Days later: 139
Gender: Female   Submitted: 2006-03-30
State:    Entered: 2006-03-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: Blood pressure: 90/60 mmHg; Full blood count pending; Gynecological examination grossly norm.
Previous Vaccinations:
Other Medications: Ferrous sulfate
Preexisting Conditions:
CDC 'Split Type': B0416342A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS 817A9   IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Abortion spontaneous, Blood pressure decreased, Unintended pregnancy, Vaginal haemorrhage
Write-up: This female subject was enrolled in the prophylactic double blind study 580299/009. On 28 April 2005, 26 May 2005 and 21 October 2005, the subject received the 1st, 2nd and 3rd dose of Human papillomavirus type 16 and 18 vaccine (HPV, IM deltoid) or hepatitis A vaccine (Havrix, 720 EU IM). The subject received Havrix (lot DVHA817A9). The subject's past medical history included 2 previous full term pregnancies, both with normal birth. The subject is a smoker (0.96 pack year). There is a family history of diabetes mellitus at the subject's paternal side (grandmother). The father has a family history of hypertension. The subject had her last menstruation on 10 December 2005. She presumed that she was pregnant. There were no other associated signs and symptoms reported until 7 March 2006, wherein she sought consultation at the local health center. Blood pressure at that time was 90/60 mmHG. She was prescribed with ferrous sulfate. On 9 March 2006, five months after the 3rd dose of Blinded vaccine, this 19 year old subject experienced vaginal spotting with no other associated symptoms. On 10 March 2006, spotting progressed to bleeding, soaking 3 pads a day, but still no consultation was done. On 11 March 2006, with persisted vaginal bleeding, she started to experience vaginal bleeding with hypogastric pain. On 12 March 2006, she underwent completion curettage after spontaneous passage of abortus in the hospital. She was discharged the same day (after 9 hours) improved and with minimal bleeding. The subject was treated with methylergometrina maleate for uterine contraction and uterotonic ferrous sulfate and ascorbic acid. The event resolved on 12 March 2006. At the time of reporting (20 March 2006), she was asymptomatic and the pelvic examination was grossly normal. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by investigational product because of the temporal relationship between the last dose and the subject's last normal menstrual period, whic
VAERS ID: 253547   Vaccination Date: 2005-11-04
Age: 21.0   Onset Date: 2006-02-20   Days later: 108
Gender: Female   Submitted: 2006-03-31
State:    Entered: 2006-03-31
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: Pregnancy Test Urine 04Nov2005 - negative; Sonogram 24Feb2006 - incomplete abort
Previous Vaccinations:
Other Medications: Iron Salt; Folic Acid
Preexisting Conditions:
CDC 'Split Type': B0417046A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 21 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia associated with HPV - 16 and/or HPV-18 in healthy young females. The subject received IM investigational product single dose on 5 May 2005, 21 June 2005 and 4 November 2005, after negative urine pregnancy tests. Site of injection was the left deltoid. On 5 May 2005, 21 June 2005 and 4 November 2005, the subject received the 1st, 2nd and 3rd IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 up Al (OH)3 (lot number was not provided). Medical history: The subject's past medical history included no previous pregnancy. She was exposed to the vaccine before conception. Her last menstrual period occurred on 22 November 2005. She was taking nutritional supplements (iron and folic acid) from January 2006 until March 2006. On 20 February 2006, 108 days after the 3rd dose of Blinded vaccine, when she was 13 weeks pregnant, this 21 year old subject presented light vaginal bleeding, for which she consulted to the ER on 21 February 2006 and on 22 February 2006. On both times the doctor recommended rest. On 24 February 2006, the bleeding increased and she consulted again to the local clinic and was referred to the local hospital where a sonogram documented spontaneous incomplete miscarriage. She was admitted to the hospital the same day. On 26 February 2006, she underwent dilation and curettage. On 27 February 2006, At the time of reporting (24 March 2006) she was in good health. She will continue in the study. The investigator considered that there was a reasonable possibility that the abortion spontaneous incomplete may have been caused by investigational product due to temporal association between the vaccine dose administration and the date of last menses.
VAERS ID: 253569   Vaccination Date: 2005-12-07
Age: 21.0   Onset Date: 2006-03-09   Days later: 92
Gender: Female   Submitted: 2006-03-31
State:    Entered: 2006-04-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Malarone (atovaquone, proguanil)
Preexisting Conditions: Pregnant, LMP date 11/05 sex female, Abortion (date not specified). No other history reported.
CDC 'Split Type': E200505578
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN AVENTIS PASTEUR       UN
YF AVENTIS PASTEUR       UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Abortion spontaneous, Unintended pregnancy, Vaginal discharge
Write-up: This is a pregnancy follow up. Initial report on 28Dec05: It was reported that a 20 yr old female pt was administered a dose of yellow fever vaccine (Stamaril, batch number not reported) in Nov 05 (site and route of admin not reported). At the time of vaccination, the pt was pregnant. No adverse reactions were reported. File to be completed. Follow up information received on 22Mar06 through pregnancy follow up form. This case was upgraded to serious. It was reported that the pt was administered a dose of Stamaril and a dose of meningococcal vaccine (Menomune, batch number AC4W135) on 07Dec05 whereas she was pregnant since 12Nov05. In Jan06, she travelled abroad for 3 weeks and took atovaquone, proguanil (Malarone) and Insect ecran cream against mosquito (not on skin but on cloth). To be noted that she had no fever nor other adverse events abroad. On 09Mar06, she experienced stomach ache treated with paracetamol (Doliprane) but in the evening, she lost a kind of liquid and went straight to the emergency services. The baby was found dead. The case is closed.
VAERS ID: 253741   Vaccination Date: 2005-11-04
Age: 26.0   Onset Date: 2005-12-18   Days later: 44
Gender: Female   Submitted: 2006-04-03
State:    Entered: 2006-04-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Pregnancy test urine 11/4/2005 negative, pregnancy test urine 12/19/2005 positive.
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0404641A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 25 year old female was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia CINII associated with human papilloma virus HPV 16 and/or HPV 18 in health young females. The subject received intramuscular investigation product single dose on 11/4/2005 after negative urine pregnancy test. Site of injection was the left deltoid. The subject did not receive 2nd or 3rd dose because of pregnancy. On 11/4/2005, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trail, an investigational formulation of Havrix vaccine containing 720 Elisa units of hepatitis A antigen and 500 ug A1 OH3. On 12/18/2005, 44 days after the 1st dose of blinded vaccine, this 25 year old subject presented vaginal bleeding. She was referred to the ER with the diagnosis of threatened miscarriage. Her last menstrual period occurred on 10/26/2005. On 12/19/2005, urine pregnancy test was positive. The subject was exposed to the vaccine immediately after conception. The estimated delivery date was 7/16/2006. On 12/21/2005, the subject presented pelvic pain associated to vaginal bleeding, for which she consulted to the ER. The subject was diagnosed as having complete spontaneous miscarriage, after 7 weeks of pregnancy. She was discharged with recommendation to consult again if the bleeding did not stop or increased. On 12/23/2005, the vaginal bleeding stopped. The event resolved on 12/23/2005. The subject is currently in good health. She will continue in the study. This event has been considered to be medically important (OMIC). The investigator reported the complete spontaneous miscarriage as possibly related to investigational product due to the temporal association between the last vaccine dose administration and the date of last menses.
VAERS ID: 253821   Vaccination Date: 2005-07-11
Age: 26.0   Onset Date: 2006-01-20   Days later: 193
Gender: Female   Submitted: 2006-04-07
State:    Entered: 2006-04-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: Pregnancy test urine 8/11/2005 positive.
Previous Vaccinations:
Other Medications: Materna (Calcium salt + magnesium salt+ Vitamin E + Vitamin A+ Ascorbic acid + pyridoxine hydrochloride + Niacinamide + Thiamine hydrochloride + Riboflavine + Vitamin D + Copper salt + Iodide salt+ folic acid + iron salt + zinc salt), Folic
Preexisting Conditions:
CDC 'Split Type': A0570905A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Foetal distress syndrome, Premature separation of placenta, Unintended pregnancy, Uterine hypertonus
Write-up: This 26 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia associated with human papilloma virus HPV 16 and or HPV 18 in health young females. The subject received intramuscular investigational product single dose on 7/11/05 following negative pregnancy test. Site of injection was the left deltoid. She did not received second and third doses because of pregnancy. On 7/11/05, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 Elisa units of Hepatitis A antigen and 500 ug A1 (OH) 3. Lot number was not provided. The subjects past medical history included no previous pregnancy. From 2005 until 3/3/2006, the subject received nutritional supplement (Materna, folic acid and iron). On 8/11/2005, 1 month after the 1st dose of blinded vaccine, this 26 year old subject was reported to be pregnant (urine pregnancy test was performed and was positive). Her last menstrual period occurred on 7/1/2005 and she was exposed to the vaccine before conception or during first trimester of pregnancy. The estimated delivery date was 4/8/2006. On 1/20/2006, six months after the 1st dose of blinded vaccine, when she was 24 weeks pregnant, this 26 year old subject experienced contractions (with out other symptoms, for which she consulted to the gynecologist. The gynecologist indicated full rest and intramuscular treatment (the subject did not remember the name). Later the contractions increased in intensity and frequency. She consulted again to the hospital and was diagnosed with abruption placentae and was hospitalised. The event resolved on 2/8/2006 and she was discharged in good health and with recommendations. On 3/3/2006, eight months after the 1st dose of blinded vaccine, this 26 year old subject went to a prenatal care appointment at 34 weeks of pregnancy. The doctor indicated that the

 

VAERS ID: 254084   Vaccination Date: 2004-10-01
Age: 26.0   Onset Date: 2005-02-11   Days later: 133
Gender: Female   Submitted: 2006-04-13
State:    Entered: 2006-04-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: 11Feb05: A pelvic examination revealed heavy vaginal bleeding and a closed cervix. 12Feb05: A pelvic ultrasound revealed a missed miscarriage. 13Feb05: A dilation and curettage was performed.
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': A0554483A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 26 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia CINII associated with human papilloma virus HPV 16 and or HPV 18 in healthy young females. The subject received intramuscular investigational product single dose on 10/1/2004. Site of injection was left deltoid. On 10/01/2004 the subject received th 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 UG A1(OH)3. On 11/11/2004, this subject had her last menstrual period. Condom was used as contraception method. According the the dates given, she was exposed to investigational product before conception. On 2/11/2005 4 months after the 1st dose of investigational product, this 26 year old subject experienced pelvic pain and vaginal bleeding. She presented to the emergency room, where a pelvic examination revealed heavy vaginal bleeding and a closed cervix. She was hospitalized with a diagnosis of threatened abortion. Her gestational age was 14 weeks, She was prescribed bed rest and indomethacin. On 2/12/2005, a pelvic ultrasound revealed a missed miscarriage. She underwent Dilation and Curettage on 2/13/2005 and was prescribed diclofenac. On 2/14/2005, after tree days, the events were considered resolved with intervention and she was discharged with a follow up appointment with the gynecologist, as well as given recommendations and condoms. The subject was to continue regular follow up in the study, but was not to receive more doses of the investigational medication. This case has been considered to be medically important (OMIC). The investigator considered there was no reasonable possibility that the missed miscarriage may have been caused by investigational product. Follow up received on 4/3/2006: following a request, the investigators and medical monitors redefined the criteria of temporal
VAERS ID: 254085   Vaccination Date: 2005-02-17
Age: 25.0   Onset Date: 2005-04-19   Days later: 61
Gender: Female   Submitted: 2006-04-13
State:    Entered: 2006-04-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: 4/15/2005 positive urine pregnancy test. 4/19/2005 a blood pregnancy test was negative. She was ref to the hospital where a new pregnancy test was positive and a pelvic ultrasound revealed a missed miscarriage. 4/22/2005 laboratory tests (u
Previous Vaccinations:
Other Medications: Oral contraceptive
Preexisting Conditions: This is the first pregnancy for the subject. Subject has history of episodes of amenorrhea of 5-6 months duration.
CDC 'Split Type': A0555087A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Pain, Pelvic pain, Placental disorder, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 24 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia CINII associated with human papilloma virus HPV 16 and or HPV 18 in healthy young females. The subjects past medical history included irregular menstrual cycles with episodes of amenorrhea of 5-6 months duration. Concomitant medications included birth control pills from 2002 to April 2005. The subject received intramuscular investigational product single dose on 2/17/2005. Site of injection was the left deltoid. On 2/17/2005, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug A1 (OH) 3. On 12/26/2004, this 24 year old subject had her last. On her first months visit on 4/15/2005, she had a positive urine pregnancy test. On 4/19/2005, 61 days after the 1st dose of investigational product, she experienced vaginal bleeding and pelvic pain. She presented to the local clinic where a blood pregnancy test was found to be negative. She was referred to the gynecology service at the local hospital. A new blood pregnancy test proved to be positive. A pelvic ultrasound was performed and revealed a missed miscarriage. On 4/19/2005, she was hospitalized and diagnosed with missed miscarriage at 16.3 weeks gestational age. Laboratory tests unspecified done on 4/22/2005 was normal. The subject underwent therapy with Oxytocin from 4/21/2005 to 4/25/2005 because the cervix remained closed and formed. On 4/26/2005, dilation and curettage was performed without complications. The events resolved on 4/27/2005 after nine days and she was discharged. She experienced some light lumbar pain on the day of discharge, but by the next day, she was asymptomatic with no vaginal bleeding. Biopsy report from 5/3/2005 revealed placental detritus. As a result of the event, the subject was not to rece
VAERS ID: 254086   Vaccination Date: 2005-05-30
Age: 25.0   Onset Date: 2005-08-18   Days later: 80
Gender: Female   Submitted: 2006-04-13
State:    Entered: 2006-04-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Pregnancy test positive, pregnancy test urine 8/16/2005 positive, Sonogram normal, 8/16/2005 positive urine pregnancy test. 8/23/2005 blood pregnancy test and an obstetric ultrasound were performed. Dilation and curettage was not required.
Previous Vaccinations:
Other Medications: Birth control
Preexisting Conditions:
CDC 'Split Type': A0571734A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   2 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 24 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia CINII associated with human papilloma virus HPV 16 and or HPV 18 in healthy young females. The subjects past medical history included birth control (unspecified). On 9/23/2004, 10/27/2004 and 5/30/2005, the subject received the 1st, 2nd and 3rd intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 UG A1 (OH)3. Lot number was not provided. On 6/30/2005, the subject had her last menstrual period. She had stopped using birth control pills on an unspecified date in June 2005. On 8/16/2005, the subject had a positive urine pregnancy test. The subject was exposed to the vaccine before conception. On 8/18/2005, 80 days after the third dose of investigational product, this 29 year old subject experienced scarce trans vaginal bleeding and pelvic pain. On 8/23/2005, she presented to the emergency room where a blood pregnancy test and an obstetric ultrasound were performed. At examination, she presented with scarce transvaginal bleeding and uterus of normal size. A sonogram revealed endometrium homogeneous of 4mm, uterus in normal position 70x32mm, ovaries normal and there was no free liquid. The subject was diagnosed with complete spontaneous miscarriage. Dilation and curettage was not required. She was discharged on the same day. On 1/26/2006, the subjects hospital chart was reviewed but no information was found about the SAE, the subject will be contact to confirm all the data. On 3/31/2006, after hospital chart review, the investigator reported that the subject had never been admitted to hospital but only in emergency ward on 8/23/2005 where she stayed for a few hours. The event was considered to be medically important (OMIC). The investigator considered there was no reasonable possibility that the compl
VAERS ID: 254087   Vaccination Date: 2005-05-20
Age: 21.0   Onset Date: 2005-09-23   Days later: 126
Gender: Female   Submitted: 2006-04-13
State:    Entered: 2006-04-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: Hematocrit 29.5% low, Hemoglobin 9.6 g/dl low, Pregnancy test urine 5/20/2005 negative, 5/20/2005 subject received 1st dose of investigational product after a negative urine pregnancy test. 9/26/2005 subject underwent dilation and curettage
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Miscarriage
CDC 'Split Type': A0575122A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Anaemia, Haemoglobin decreased, Malaise, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 21 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia CINII associated with human papilloma virus HPV 16 and or HPV 18 in healthy young females. The subject received intramuscular investigational product single dose on 5/20/2005, after a negative urine pregnancy test. Site of injection was the left deltoid. She did not receive more dosed. On 5/20/2005, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug A1 (OH) 3. Lot number was not provided. The subject had 1 previous miscarriage. On 7/6/2005, the subject had her last menstrual period and was subsequently found to be pregnant. The subject was exposed to the vaccine before conception. Estimated date of delivery was 4/23/2006. On 9/23/2005, four months after receiving the first dose of investigational product, when she was ten weeks pregnant, the subject experienced malaise and pelvic pain. On 9/24/2005, when she experience fetid vaginal bleeding, she consulted to the local clinic who referred her to the hospital. She was admitted and diagnosed with incomplete miscarriage. She was treated with an unspecified antibiotic. On 9/26/2005, she underwent dilation and curettage without complications. During the hospitalization, it was determined that subject had anemia as confirmed by hemoglobin level of 9.6 reference range 11.9 - 16.0 g/dl and hematocrit level of 29.5% (reference range 36-54%). The events resolved on 9/27/2005 and the subject was discharged on the same day with an appointment scheduled at the local clinic to follow up on the anemia. She was prescribed iron poly maltose (Intrafer). As a result of the miscarriage, the subject was not to receive any more doses of investigational product, but was to remain in the study. This event was considered as medically imp
VAERS ID: 254088   Vaccination Date: 2005-06-02
Age: 38.0   Onset Date: 2005-06-02   Days later: 0
Gender: Female   Submitted: 2006-04-13
State:    Entered: 2006-04-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Diabetes mellitus, non smoker
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions:
CDC 'Split Type': B0384222A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS AHAVB026AB   IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: This perspective pregnancy case was reported by a nurse and described the occurrence of drug exposure during pregnancy in a 38 year old female subject who was vaccinated with hepatitis A vaccine Havrix for prophylaxis. There were no concurrent medications. On 6/2/2005 the subject received unspecified dose of Havrix 1 injection, in the left arm. On 6/10/2005 it was confirmed that the subject was pregnant. The subjects last menstrual period started on 5/6/2005. At the time of reporting the outcome was unknown. The estimated date of delivery was 2/10/2006. Follow up information received on 4/4/2006: it was reported that the patient was a non smoker, Her medical history included diabetes mellitus and she did not use alcohol. On 8/5/2005 at eight weeks of gestation the patient had a spontaneous abortion. This case was assesses as medically serious by manufacturer (OMIC).
VAERS ID: 254089   Vaccination Date: 2005-09-23
Age: 19.0   Onset Date: 2005-11-12   Days later: 50
Gender: Female   Submitted: 2006-04-13
State:    Entered: 2006-04-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Pelvic X ray 12/03/2003 abnormal, pregnancy test 11/28/2005 positive.
Previous Vaccinations:
Other Medications: Jasmine (ethinyloestradiol + progesterone)
Preexisting Conditions:
CDC 'Split Type': B0407326A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Laboratory test abnormal, Unintended pregnancy, Vaginal discharge
Write-up: This 19 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia CINII associated with human papilloma virus HPV 16 and or HPV 18 in healthy young females. The subject received intramuscular investigational product single dose on 6/10/2005 and on 9/23/2005, following negative pregnancy test. Site of injection was the left deltoid. On 6/10/2005 and 9/23/2005, the subject received the 1st and 2nd intramuscular injection of blinded study vaccine in the left deltoid. The subject has been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug A1 (OH) 3. Lot number was not provided. Since 2004, the subject has used pills (Jasmine) as contraception method. On 1/18/2005, the subject reported during her third dose visit that on 11/28/2005, a blood pregnancy test was performed at the local clinic with a positive result. Her last menstrual period occurred on 10/12/2005. The subject was exposed to the vaccine before conception. Later the pregnancy test was repeated and it was also positive. However, she continued using birth control pills. on 12/3/2005, a pelvic sonogram documented a small amount of liquid in the vaginal Cul de sac, without other alteration. She did not present vaginal bleeding or other complications and was currently in good health. A diagnosis of early pregnancy loss was made. She did not receive the third dose. She will continue in the study. The event resolved on 12/3/2005. This event has been considered to be medically important (OMIC). The investigator considered this event not related to the study vaccine due to the amount of time passed between the last dose application and the date the event occurred. Follow up received on 4/5/2006: following a request, the investigators and medical monitors redefined the criteria of temporal association between vaccination and adverse events related to pregnancies. Therefore, the investigator will co
VAERS ID: 254090   Vaccination Date: 2005-08-10
Age: 25.0   Onset Date: 2005-10-27   Days later: 78
Gender: Female   Submitted: 2006-04-13
State:    Entered: 2006-04-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Diagnostic ultrasound 11/28/2005 negative, pregnancy test 11/23/2005 positive, pregnancy test negative, pregnancy test urine 11/23/2005 positive, Pregnancy test urine 1/23/2006 negative.
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0407514A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 25 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia CINII associated with human papilloma virus HPV 16 and or HPV 18 in healthy young females. The subject received intramuscular investigation product single dose on 8/10/2005 after negative pregnancy test. Site of injection was the left deltoid. She will continue in the study but will not receive more vaccines doses. On 2/17/2005, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug A1 (OH) 3. Lot number was not provided. The subject had a medical history of regular menstrual cycles of 30*4 days and sexual abstinence. On 11/23/2005, the subject reported a menstrual delay since 10/27/2005 and since 11/18/2005 she presented vaginal bleeding but she did not consulted. Her last menstrual period occurred on 9/27/2005. The subject was exposed to the vaccine before conception. On 11/23/2005, the urine and the blood pregnancy test were positive. The estimated delivery date was 8/23/2006. On 11/26/2005, an ultrasound diagnostic documented absence of gestational sac. A new ultrasound diagnostic and a blood pregnancy test were recommended but the subject did not perform them. On 1/6/2006, urine pregnancy test was negative. Considering that the participant had 2 positive pregnancy test and a latter a negative one, the investigator considered that this is a spontaneous abortion. At the time of reporting, the subject was in good health. This case has been considered to be medically important (OMIC). The investigator considered that there was no reasonable possibility that the spontaneous abortion may have been cause by investigational product. The subject will continue in the study but will not receive more vaccine doses. Follow up received on 4/6/2006: following a request, the in
VAERS ID: 254332   Vaccination Date: 2005-04-04
Age: 37.0   Onset Date: 2005-04-04   Days later: 0
Gender: Female   Submitted: 2006-04-17
State:    Entered: 2006-04-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: 25Mar05: Beta human chorionic gonadotropin (unsp): pregnant
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy NOS (LMP=25Mar05).
CDC 'Split Type': WAES0505USA02613
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.       UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Intra-uterine death, Unintended pregnancy
Write-up: Information has been received from a health professional concerning a 37 year old female, with no reported past medical history, who in April 2005 (reported ast 2-3 weeks ago), was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (batch not reported). Since about 15 days, the patient was reported to be pregnant (last menstrual period dated back to 4 weeks). Lmp was approximately 3/19/2005. No adverse reaction was reported following vaccination. Follow up information from a health professional indicated that the patients pregnancy began on 3/25/2005. On 5/10/2005 the patient experienced a spontaneous abortion due to an intra uterine death of the fetus. Follow up information firm a health professional indicated that the patient saw a gynecologist on 5/10/2005. It was reported that the embryonic cardiac activity had stopped, within the previous week according to the cranio caudal length, and that the patient had already started to bleed. The embryo expulsion was spontaneous and without complication. There had been no curettage nor antomopathological study. No risk factor could be identified by the reporter (no infectious context, non smoking patient)except the maternal age. It was noted that the patient also received in the per-conceptional period a treatment with norfloxacin. No more information was available. The case is closed. Spontaneous abortion was considered to be an other important medical event (OMIC). Other business partner numbers include E200501612
VAERS ID: 257838   Vaccination Date: 2006-02-20
Age: 30.0   Onset Date: 2006-04-20   Days later: 59
Gender: Female   Submitted: 2006-06-02
State:    Entered: 2006-06-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0415733A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS ATYAB006AE   IM UN
TD AVENTIS PASTEUR Z0251   IM UN
TYP AVENTIS PASTEUR Z0251   IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Medication error, Unintended pregnancy
Write-up: This case was reported by a practice nurse and was a prospective case of pregnancy in a 30 year old female subject who was vaccinated with hep A and polysaccharide typhoid vaccine (Hepatyrix) for prophylaxis. On 20Feb06 the subject received unspecified dose of Hepatyrix (1 inj, IM, unk deltoid). At an unspecified time after vaccination with Hepatyrix, the subject was found to be pregnant. The last menstrual period and estimated date of delivery were not reported. At the time of reporting, the pregnancy was ongoing. Follow up information received on 24May06. It was reported that on 20Feb06, the pt received an unspecified dose of Revaxis (1 injection, IM, unk deltoid). The date of the last menstrual period was 05Feb06 and the estimated date of delivery was 12Nov06. On 20Apr06, the pt experienced a spontaneous abortion.
VAERS ID: 258372   Vaccination Date: 2006-01-16
Age: 26.0   Onset Date: 2006-03-17   Days later: 60
Gender: Female   Submitted: 2006-06-12
State:    Entered: 2006-06-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Pregnancy test 3/17/2006 positive, pregnancy test urine 4/9/2006 positive, pregnancy test urine 6/1/2006 negative, Sonogram 3/17/2006 ab gest sac, Sonogram 6/1/2006 no pregnancy.
Previous Vaccinations:
Other Medications: Medroxyprogesterone, Oral contraceptive.
Preexisting Conditions: Polycystic Ovary
CDC 'Split Type': B0426355A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Amenorrhoea, Ovarian cyst, Unintended pregnancy
Write-up: This 25 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial Neoplasia associated with human papilloma virus 16 and or HPV 18 in health young females. On 8/4/2005, 10 17/2005 and 1/16/2006, the subject received the 1st, 2nd and 3rd dose of intramuscular injection of blinded study vaccine in the left deltoid after negative pregnancy test. The subject had been randomized to received the active control in this trial, an investigational formulation of Havrix vaccine containing 720 Elisa units of hepatitis A antigen and 500 ug Al (OH) 3. Lot number X. On 3/17/2006, 60 days after the 3rd dose of blinded vaccine, this 25 year old subject consulted a private gynecologist. A blood pregnancy test was positive and a sonogram showed absence of a gestational sac. Medroxyprogesterone for one month was indicated. The subject continued with amenorrhea. On 4/9/2006, an urine pregnancy test was positive. She didn't present vaginal bleeding. On 6/1/2006, she was evaluated by the study doctor. Relevant test included an urine pregnancy test which was negative, a pelvic exam which showed a closed, formed cervix, a normal uterus, no vaginal bleeding. The rest was normal. In the afternoon she attended an appointment with the private gynecologist who performed a sonogram and told her that she was not pregnant. It was also indicated that she presents polycystic ovaries (non serious). The subject was finally diagnosed as having a complete spontaneous abortion due to two positive pregnancy tests and later a negative one (last menstrual period 2/17/2006, estimated delivery date unknown). The subject was exposed to the vaccine before conception. She had used oral contraceptives until January 2006. The event resolved on 6/1/2006. She is currently in good health. She will continue in the study. This event has been considered to be medically important (OMIC). The investigator reported the complete spontaneous abortion as possibly related to investigational product due to the temporal associatio

 

VAERS ID: 258951   Vaccination Date: 2005-11-18
Age: 19.0   Onset Date: 2006-02-17   Days later: 91
Gender: Female   Submitted: 2006-06-28
State:    Entered: 2006-06-28
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Blood test, 2/21/06: anemia; Physical examination, 2/20/06: see text; Pregnancy test urine, 11/18/05: negative; Pregnancy test urine, 1/23/06: positive; Sonogram, 2/21/06: see text.
Previous Vaccinations:
Other Medications: Iron salt; Folic acid
Preexisting Conditions:
CDC 'Split Type': B0409122A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Anaemia, Cervix neoplasm, Laboratory test abnormal, Medication error, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 19 year old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia associated with human papillomavirus (HPV) - 16 and/or HPV - 18 in healthy young females. The subject received intramuscular investigational product single dose on 18 November 2005, after negative pregnancy test. Site of injection was the left deltoid. On 23 January 2006, pregnancy urine test was positive, that is why she did not receive the second or third dose. On 18 November 2005, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug Al (OH)3. Lot number was not provided. The subject's past medical history included no previous pregnancy. On 23 January 2006, 2 months after the 1st dose of blinded vaccine, this 19 year old subject was reported to be pregnant. her last menstrual period occurred on 22 December 2005. The subject was exposed to the vaccine before conception. On 23 January 2006, urine pregnancy test was positive. The estimated delivery date was 30 September 2006. On 17 February 2005, 91 days after the 1st dose, the subject experienced a spontaneous complete miscarriage, gestational age was 9.5 weeks according to her last menstrual period. She presented vaginal bleeding and pelvic pain for which she consulted at the emergency room of the local hospital. On 20 February 2006, she was evaluated by the study doctor who documented a closed, formed and painful cervix and moderate vaginal bleeding. An appointment with a gynecologist was coordinated. On 21 February 2006, a sonogram documented 6 weeks pregnancy without fetal heart activity, intramuscular progesterone, quantified sub beta 2264.0 mUI/ml (63.803-151.414 according to gestational age) and the hemogram documented anemia (she was taking iron and folic acid). On 28 February 2006, a sonogram documented co
VAERS ID: 259004   Vaccination Date: 2005-12-20
Age: 31.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2006-06-29
State:    Entered: 2006-06-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Ectopic pregnancy
CDC 'Split Type': WAES0601USA01597
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP MERCK & CO. INC. 0350R 2    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: Information has been received from a health professional concerning a 31 yr old female with a history of an ectopic pregnancy (11Nov05: approx 4 wks gestation-as a result pt was given methotrexate while in hospital) who on 20Dec05 was vaccinated with a 10mcg third dose of hep B virus vaccine rHBsAg (yeast) (thimerosal free) (lot 651816/0350R). Suspect therapy included methotrexate since approx Dec 2005, and was advised not to become pregnant for 3 months. Subsequently the pt discovered that she was pregnant. Her LMP date was not reported. The pt did not experience any adverse effects following vaccination. This case will be followed up. Follow up information indicated that on an unk date in Dec 2005, the pt had a spontaneous abortion. It was reported that the pt was not pregnant at the time follow up (28Apr06). Upon internal review, spontaneous abortion was considered to be an other important medical event (OMIC). Other business partner numbers included: E200505472. This report was received by manf on 28Jun06.
VAERS ID: 259537   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2006-07-13
State:    Entered: 2006-07-13
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Medullary Aplasia, second pregnancy
Diagnostic Lab Data: Anti HBc antibody: 1999, May 2002, Dec 2002, May 2006-positive. Anti HBs antibody: 1999- neg, May 2002-positive, Dec 2005-neg, May 2006-neg. HBV DNA detectable: May 2006-positive. Hep B DNA essay: 1999-neg, May 2002-neg; Dec 2005-neg. Plate
Previous Vaccinations:
Other Medications: Cyclosporin; Blood transfusion
Preexisting Conditions: Bone graft, miscarriage of pregnancy
CDC 'Split Type': B0430017A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP UNKNOWN MANUFACTURER        
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Bone marrow depression, Drug ineffective, Hepatitis, Platelet count decreased, Unintended pregnancy, Viral infection
Write-up: This case was reported by a physician and described the occurrence of acute hep B in a female subject aged between 30 and 39 yrs old who was vaccinated with unspecified hep B vaccine (manf unspecified) for prophylaxis. In 1996, the subject received unspecified number of hep B vaccines (unk manf, unk batch ref). In 1999, during a blood donation, serologic test evidenced positive anti HBc antibody level (unk starting date). HBV DNA was negative. In May 2002, she developed idiopathic medullary aplasia (non suspected adverse event). Anti HBc antibody was positive. As platelet count was at 10,000/mm3, she received blood transfusion followed by bone marrow transplantation from her sister (she had negative hep B serology). At that time, hep B serology showed positive anti HBc antibody, negative HBs antigen and positive HBs antibody (positivity probably due to the transfusion according to the reporter). She received a treatment with cyclosporin (Cyclosporine). In 2005, as she wished to be pregnant; cyclosporine was stopped. In Dec 2005, hep B serology showed positive anti HBc antibody, neg HBV DNA and negative anti HBs antibody. In 2006, she became pregnant. At a gestational age of 6 weeks, she had a spontaneous abortion. In 2006, a short period later, she became pregnant again. At 11 wks of gestation, she developed acute hep b with icterus, transaminase increased around 2500 to 3000 IU/l and normal prothombine time. Hep B serology showed positive anti HBc antibody, positive HBV DNA, positive HBs antigen and negative anti HBs antibody. According to the reporter, transplantation and then pregnancy might have reactivate hep B virus. At the time of reporting, she was around 20 weeks of amenorrhea and had no concomitant treatment. Outcome of the events were unresolved. This case was assessed as medically serious by manf (OMIC).
VAERS ID: 259991   Vaccination Date: 2006-02-06
Age: 21.0   Onset Date: 2006-04-16   Days later: 69
Gender: Female   Submitted: 2006-07-20
State:    Entered: 2006-07-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: Pregnancy test 18Apr06 positive; Pregnancy test urine 04Jul05 negative; Pregnancy test urine 18Feb06 negative; Pregnancy test urine positive.
Previous Vaccinations:
Other Medications: Oral contraceptive
Preexisting Conditions:
CDC 'Split Type': B0430588A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Thrombosis, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 20-year-old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia (CINIT) associated with human papillomavirus virus (HPV)-16 and/or HPV-18 in healthy young females. The subject received intramuscular investigational product single dose on 4 July 2005 and 6 February 2006, after negative urine pregnancy test. She did not receive the second dose, Site of injection was the left deltoid. On 4 July 2005 and 6 February 2006, the subject received the 1st and 2nd intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug Al 9OH) 3. Lot number was not provided. The subject had regular menstrual cycles of 28 4-5 days. She was using oral contraception for birth control but she stopped them (unknown date). Her last menstrual period occurred on 18 February 2006. on unknown data, she had a positive urine pregnancy test. On 18 April 2006, 71 days later after the 2nd dose of blinded vaccine (3rd study dose), this 20-year-old subject developed a spontaneous incomplete miscarriage after 8 weeks of pregnancy according to the data of last menses. She initiated with light vaginal bleeding, for which she consulted the local clinic where a pregnancy test was positive. Pelvic examination showed that the cervix was closed. Rest was indicated. On 27 April 2006, the bleeding increased and it was associated with clots. She consulted the Emergency Room of the local clinic and was referred to the local hospital where she was admitted. On April 29 2006, a sonogram showed a spontaneous incomplete miscarriage of 10 weeks gestation. On 29 April 2006, she underwent dilation and curettage without complications. On 30 April 2006, she was discharged from the hospital. on 3 May 2006, the bleeding stopped and the event resolved on the same day. At the time of reporting, she was in
VAERS ID: 261434   Vaccination Date: 2006-04-17
Age: 26.0   Onset Date: 2006-06-20   Days later: 64
Gender: Female   Submitted: 2006-08-11
State:    Entered: 2006-08-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: Pregnancy test 6/20/06 positive.
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0433064A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Pelvic pain, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 26 year old female subject was enrolled in a blinded study. The subject received IM investigational product single dose on 4/23/2005, 7/27/05 and 4/17/06. Site of injection was the left deltoid. On 6/23/05, 7/27/05 and 4/17/06, the subject received the 1st 2nd and 3rd IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the active control in this trial, an investigational formulation of Havrix vaccine containing 720 Elisa units of hepatitis A antigen and 500 ug AL OH 3. Lot number was not provided. Medical history, the subject used condoms as contraception method. She didn't recall when she ceased use. She didn't know that she was pregnant. On 6/20/06, 64 days after the 3rd dose of Blinded vaccine, this 26 year old subject developed light vaginal bleeding and pelvic pain after 7 weeks of pregnancy for which she went to the ER of the local hospital (last menstrual period 5/3/06, the subject was exposed to the vaccine before conception. In the E, she had a positive pregnancy test and she was hospitalised on the same day with the diagnosis of threatened miscarriage. During her stay in the hospital, apparently several beta HCG test were performed. On 6/27/06, she was told that she had a spontaneous incomplete miscarriage and she underwent a dilation and curettage after 8 weeks of pregnancy. The event resolved on 6/28/06 and she was discharged on the same day in good conditions. She is currently in good health. She will continue in the study. This event has been considered to be medically important (OMIC). The investigator reported the abortion spontaneous incomplete as possibly related to investigational product due to the temporal association between the last vaccine dose administration and the date of last menstrual period.
VAERS ID: 262585   Vaccination Date: 2006-03-31
Age: 26.0   Onset Date: 2006-07-19   Days later: 110
Gender: Female   Submitted: 2006-09-05
State:    Entered: 2006-09-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Current Illness: Irregular menstrual cycles.
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Oral contraceptive
Preexisting Conditions:
CDC 'Split Type': B0435763A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy, Uterine hypertonus, Vaginal haemorrhage
Write-up: This 26 year old female subject was enrolled in a blinded study. The subject received IM investigational product single dose on 10/21/2005, 11/22/2005 and 3/31/2006, after negative urine pregnancy tests. Site of injection was the left deltoid. On 10/21/2005, 11/22/2005 and 3/31/2006, the subject received the 1st IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigation formulation of Havrix vaccine containing 720 Elisa units of hepatitis A antigen and 500 ug AL OH 3. Lot number was not provided. The subject had a history of irregular menstrual cycles. She was using oral contraceptives, but she did not know when she stopped taking them. Her last menstrual period occurred on April 2006. She was exposed to the vaccine before conception. The subject did not know that she was pregnant. On 7/19/06, 110 days after the 3rd dos of Blinded vaccine, this 26 year old subject experienced an abortion spontaneous complete. She began with significant vaginal bleeding and when it increased she consulted a private doctor. A sonogram was performed which revealed a miscarriage of 8 weeks gestation and she was referred to the ER of the local hospital. On 7/20/06, she was admitted to the Gynecology ward, where she was administered IV fluids and she presented contractions. On 7/21/06, a new sonogram revealed absence of a gestational sac or retained products of conception (spontaneous abortion complete), so no dilation and curettage was performed. On 7/21/06, she was discharged from the hospital and the event resolve don the same day. At the time of reporting, she was in good health. She will continue in the study. This event has been considered to be medically important (OMIC). The investigator reported the abortion spontaneous complete as possibly related to investigational product due to the temporal association between the last vaccine dose administration and the last menstrual period.
VAERS ID: 263087   Vaccination Date: 2005-10-10
Age: 21.0   Onset Date: 2006-03-25   Days later: 166
Gender: Female   Submitted: 2006-09-15
State:    Entered: 2006-09-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Iron Salt, Folic Acid
Preexisting Conditions:
CDC 'Split Type': B0407891A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain lower, Abortion spontaneous, Back pain, Premature labour, Unintended pregnancy
Write-up: This 21 year old female subject was enrolled in a blinded study. The subject received IM investigational product single dose on 8/4/05 nd 10/10/05, after negative urine pregnancy test. She did not receive the 3rd dose due to pregnancy. Site of injection was the left deltoid. On 8/4/05 and 10/10/05, the subject received the 1st and 2nd IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the active control in this trial, an investigation formulation of Havrix vaccine containing 720 Elisa units of hepatitis A antigen and 500 ug A1 OH3. Lot number was not provided. Medical history the subject used iron salt and folic acid for prenatal care between Nov 2005 and March 2006. On 1/18/06, 3 months after the 2nd dose of Blinded vaccine, this 21 year old subject was reported to be pregnant. her last menstrual period occurred on 9/28/05, The subject was exposed to the vaccine during the 1st trimester of pregnancy. The estimated delivery date was 6/9/06. She was attending prenatal care visits. On 3/26/06, five months after the 2nd dose of blinded vaccine and when she was 29.2 weeks pregnant, this 21 year old subject under went cesarean delivery for unknown causes. She presented lumbar pain that irradiated to the lower abdomen for which she consulted to the ER for the local hospital. She was evaluated and admitted because she presented 10cm of cervical dilation and a transverse fetal position (no more details known). She indicated that it was until the C section was performed that the doctor realized it was a twin pregnancy. The female new born died on the same day probably due to prematurity (for more details see case B0407891B and B0407891C). The event resolved on 3/28/06. At the time of reporting, she was in good health. She will continue in the study. The investigator reported the cesarean delivery as possibly related to investigational product due to the temporal associated between the last vaccine dose administration and the onset of the last menstrual period. Follow up
VAERS ID: 264158   Vaccination Date: 2006-02-16
Age: 26.0   Onset Date: 2006-03-23   Days later: 35
Gender: Female   Submitted: 2006-10-09
State:    Entered: 2006-10-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Dianette (Ethinyloestradiol + Cyproterone acetate)
Preexisting Conditions:
CDC 'Split Type': B0441215A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS AHBVB118AF   IM UN
IPV AVENTIS PASTEUR Z0117     UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: This retrospective pregnancy case was reported by a regulatory authority and described the occurrence of pregnancy in a 26 year old female subject who was vaccinated with Engerix B, rabies (Imovax) for prophylaxis. Concurrent medications included Dianette. On 2/16/06 the subject received unspecified dose of Engerix B 1 injection, IM, unspecified dose of Imovax unk. The subject was unaware that she was pregnant and was exposed to the vaccines in her first trimester. The date of last menstrual period was 1/12/06. On 3/23/06, approx 35 days after vaccination with Engerix B and Imovax, the subject experienced blighted ovum and spontaneous abortion. The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). At the time of reporting the outcome of the events was unspecified. Verbatim test received: the pt received inactivated Polio vaccine, Imovax, batch number Z0117-2 and Hepatitis B vaccine Engerix B batch number AHBVB118AF during an occupation health visit. The pt was 5 weeks pregnant at the time of receiving the vaccinations but was not aware of her pregnancy. The pt became pregnant in the first cycle after stopping Dianette. Approx five weeks post vaccination the pt experienced an anembyonic pregnancy and on the following day, the pt experienced a spontaneous abortion. Pt outcome was not reported.
VAERS ID: 265928   Vaccination Date: 2006-09-21
Age: 22.0   Onset Date: 2006-09-21   Days later: 0
Gender: Female   Submitted: 2006-10-31
State:    Entered: 2006-11-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy, headache, asthma.
CDC 'Split Type': WAES0610USA07911
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP MERCK & CO. INC. 0764R 0 IM LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Dizziness, Malaise, Nausea, Unintended pregnancy
Write-up: Information has been received from a health professional concerning a 22 year old female pt who on 9/21/06 was vaccinated IM in the left arm with a first dose of Hep B virus vaccine (thimerosal free) (lot 653168/0764R, Batch ND42490). On 9/21/06, in the evening following the immunization, the pt felt sick. At the time of the report the pt had not recovered. The reporter considered this to be a non serious reaction. Follow up information received on 10/6/06 noted that the pt had concurrent conditions of episodic headaches since 2005 and occasional asthma. The pts family was unk. In the evening following vaccination, 9/21/06, the pt experienced nausea and feeling faint. The pt was reassured and advised to see the general practitioner if symptoms persisted. It was unk at the time of the report if the pt recovered. The reporter considered this to be non serious reaction. Further information was received on 10/23/06. The pt had a miscarriage on 10/13/2006, 22 days after receiving first vaccination with Hepatitis B. The pt had not realized she was pregnant at the time of vaccination. The pt was about 6 or 7 weeks pregnant when she had the miscarriage. The pt had not yet shown the reporter the discharge summary. Upon internal review, miscarriage was determined to be an other important medical event (OMIC). Other business partner numbers include E200604861. No further information is available.
VAERS ID: 266515   Vaccination Date: 2005-12-20
Age: 22.0   Onset Date: 2006-04-21   Days later: 122
Gender: Female   Submitted: 2006-11-10
State:    Entered: 2006-11-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Iron salt, folic acid, condom
Preexisting Conditions:
CDC 'Split Type': B0417149A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy, Vaginal haemorrhage
Write-up: This 22 year old female subject was enrolled in a blinded study associated with human papillomavirus HPV 16 and or HPV 18 in health young females. The subject received IM investigational product single dose on 12/20/2005, after a negative urine pregnancy test. Site of injection was the left deltoid. She did not receive the second or third dose. On 12/20/05, the subject received th 1st IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of Hep A antigen and 500 ug AL (Oh) 3. Lot number unknown. The subjects past medical history included no previous pregnancy. On 3/21/06, 3 months after the 1st dose of blinded vaccine, this 22 year old subject was reported to be pregnant. Condom was used as contraception method, but she stopped using it after vaccination (10/20/05). Her last menstrual period occurred on 12/7/05, The subject was exposed to the vaccine before conception or in first trimester. The estimated delivery date was 9/15/06. She received prenatal care. She took iron and folic acid from Feb 2006 until April 2006. On 4/21/06, 4 months after the 1st dose of blinded vaccine and after 20 weeks of pregnancy, the subject presented slight vaginal bleeding for which she consulted to the ER of the local clinic. She was referred to the local hospital. At pelvic exam cervix was dilated 1cm which was the reason why she was hospitalized. A sonogram was normal. A few hours later the bleeding increased and a new sonogram showed that the fetus was not alive. IV solution was indicated and she expelled rests. On 4/23/06 she under went D and C with out complications. On 4/24/06 she was discharged with oral antibiotic treatment (she does not know the name) and Acetaminophen. She reported that the vaginal bleeding stopped completely on 4/29/06. AT the moment of reporting, the subject was in good health. She will continue in the study. The investigator reported the spontaneo

 

VAERS ID: 266866   Vaccination Date: 2006-02-16
Age: 26.0   Onset Date: 2006-03-23   Days later: 35
Gender: Female   Submitted: 2006-11-15
State:    Entered: 2006-11-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: Dianette
Preexisting Conditions:
CDC 'Split Type': B0446607A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS     IM UN
IPV UNKNOWN MANUFACTURER       UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Unintended pregnancy
Write-up: This case was reported by a regulatory authority and described the occurrence of blighted ovum in a 26 year old female subject who was vaccinated with Hep B vaccine (Engerix B) and IPV for prophylaxis. Concurrent medications included Dianette. On 2/16/06 the subject received unspecified dose of Engerix B, 1 injection, IM, unspecified dose of IVP injection. On 3/23/06, at an unspecified time after vaccination with Engerix B and IPV , the subject experienced blighted ovum and on 3/24/06 experienced spontaneous abortion. The pt was vaccinated in the fifth week of gestation. The pt became pregnant in the first cycle after stopping Dianette. Approx five weeks post vaccination the pt experienced an embryonic pregnancy and on the following day experienced the spontaneous abortion. This case was assessed as medically serious by manufacturer (OMIC).
VAERS ID: 267392   Vaccination Date: 2006-09-21
Age: 22.0   Onset Date: 2006-09-21   Days later: 0
Gender: Female   Submitted: 2006-11-20
State:    Entered: 2006-11-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Asthma, Headache
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0447158A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS ND42490   IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Dizziness, Nausea, Syncope, Unintended pregnancy
Write-up: This retrospective pregnancy case was reported by a regulatory authority and described the occurrence of dizziness in a 22 year old female subject who was vaccinated with Hepatitis B vaccine (HBvaxPRO) for prophylaxis. Concurrent medical conditions included asthma and headache. At the time of reporting the estimated date of delivery and date of last menstrual period were unk. On 9/21/06 the subject received unspecified dose of HBvaxPRO IM. On 9/21/06, at an unspecified time after vaccination with HBvaxPRO, the subject experienced dizziness and nausea. On 10/13/06, 22 days after vaccination with HBvaxPRO the pt had miscarriage. The regulatory authority considered that this case was clinically significant or requiring intervention (OMIC). At the time of reporting the outcome of the events was unspecified. Verbatim text received: in the evening following the vaccination the pt experienced nausea and feeling faint. The pt had a miscarriage 22 days after first receiving vaccination. The pt had not realized she was pregnant at the time of vaccination. The pt was about 6 to 7 weeks pregnant when she had the miscarriage.
VAERS ID: 268076   Vaccination Date: 0000-00-00
Age: 36.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2006-11-28
State:    Entered: 2006-12-01
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: UNK
Preexisting Conditions: Pregnancy NOS
CDC 'Split Type': WAES0611USA02742
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC.     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy, Vaginal haemorrhage
Write-up: Information has been received from a health professional concerning a 36 year old female with no medical history reported, who in Sept 2006 (approx 3-4 weeks prior to 10/12/06) was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medications. The pt had her last menstrual period on 9/2/06 and it was suspected that she was pregnant at the time of vaccination. No adverse effect was reported at the time of the initial report. Additional information received on 11/16/06: In Nov 2006, the pt experienced spotting and bleeding. An ultrasound scan was performed and although the pt was 9 weeks pregnant, the birth sac was only five weeks in size. The bleeding continued ant the pt experienced a spontaneous abortion. On 11/9/06 and evacuation of retained products of conception was performed. A specimen has not been sent for histology. No further information was provided. The reporter considered the pts spontaneous abortion to be an other important medical event (OMIC). Other business partner numbers included E200605290 and 44727.
VAERS ID: 273441   Vaccination Date: 2005-12-21
Age: 23.0   Onset Date: 2006-01-30   Days later: 40
Gender: Female   Submitted: 2007-03-05
State:    Entered: 2007-03-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: UNK
Diagnostic Lab Data: Pregnancy test 30Jan2006 positive, Pregnancy test negative, pregnancy test urine 05Jan2006 positive, sonogram 15Feb2006 no pregnancy.
Previous Vaccinations:
Other Medications: Condom
Preexisting Conditions:
CDC 'Split Type': B0460232A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous complete, Drug exposure during pregnancy, Pregnancy, Pregnancy test negative, Pregnancy test positive, Ultrasound scan, Vaginal haemorrhage
Write-up: This 23-year-old female subject was enrolled in a blinded study (580299 009). The subject received intramuscular investigational product single dose on 13 July 2005, 17 August 2005 and 21 December 2005, after negative urine pregnancy tests. Site of injection was the left deltoid. On 13 July 2005, 17 August 2005 and 21 December 2005, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of Hepatitis A antigen and 500 Ug AL (OH) 3. Lot number unknown. The subject used condom as contraception method. her last menstrual period occurred on 29 November 2005. The subject was exposed to the vaccine during 1st trimester of pregnancy. On 05 January 2006, in account of menstrual delay she had a positive urine pregnancy test. The estimated delivery date was 06 September 2006. The pregnancy was not reported to the study. She did not attend prenatal care. On 03 January 2006, 40 days after the 3rd dose of Blinded vaccine and after approximately 9 weeks of pregnancy, this 23-year-old subject experienced abortion spontaneous complete. the same day, she initiated with vaginal bleeding for which she consulted the ER at the local clinic. With another positive pregnancy test, the subject was indicated strict bed rest and the vaginal bleeding stopped 5 days later. Afterwards another pregnancy test was negative (she did not remember the exact date). On 15 February 2006, a sonogram was performed without evidence of pregnancy. The investigators considered as resolution date for this event, 04 February 2006, the day the vaginal bleeding stopped. This event has been considered to be medically important. The investigator reported the abortion spontaneous complete as possibly related to investigational product due to the temporal association between the last vaccine dose administration and the LMP.
VAERS ID: 279102   Vaccination Date: 2003-06-11
Age: 37.0   Onset Date: 2003-06-11   Days later: 0
Gender: Female   Submitted: 2007-05-18
State:    Entered: 2007-05-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: ultrasound 15?Sep03hygroma cystic was observed
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0705USA01844
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP MERCK & CO. INC.     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Chromosome abnormality, Cystic lymphangioma, Drug exposure during pregnancy, Intra-uterine death, Trisomy 21, Ultrasound scan abnormal
Write-up: Information has been received from a health authority concerning a 37 year old female who on 26-MAR-2003 and intramuscularly on 11-JUN-2003 was vaccinated with first and second doses of Recombivax HB respectively. Additional suspect vaccination included oral Vivotif between 21-MAR-2006 TO 25-MAR-2003, tetanus toxoid (manufacturer unknown) IM on 05-MAR-2003 and diphtheria toxoid (manufacturer unknown) IM on 05-MAR-2003. On 15-SEP-2006 she had a spontaneous abortion at 10 weeks of gestation due to fetal death by a chromosome disorder (trisomy on chromosome 21). An hygroma cystic was observed with an echography. It was reported that the patient had no disease during pregnancy and no exposure to toxic substances or radiations. No further information is available. Other business partner numbers include E2007-02906 and 614932444.
VAERS ID: 282195   Vaccination Date: 2007-01-09
Age: 22.0   Onset Date: 2007-03-15   Days later: 65
Gender: Female   Submitted: 2007-06-18
State:    Entered: 2007-06-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: Blood human chorionic gonadotr see text, Ultrasound scan see text
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0461627A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB GLAXOSMITHKLINE BIOLOGICALS     UN UN
RAB UNKNOWN MANUFACTURER     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan
Write-up: This case was reported by a physician and described the occurrence of pregnancy in a female subject of 22 year old who was vaccinated with Twinrix, GlaxoSmithKline, Typherix and Anti-rabies vaccine for prophylaxis. On 27 December 2006 the subject received unspecified dose of Typherix (unknown) and the 1st dose of Typherix (unknown). On 9 January 2007 the subject received 2007 the subject received 2nd dose of Twinrix (unknown) and unspecified dose of Anti-rabies vaccine. Within one month after vaccination the subject was found to be pregnant. The subject's last menstrual period was on 20 January 2007. The estimated delivery date was on 26 October 2007. In the follow up received on 12 June 2007 it was mentioned that on 15 March 2007, after 8 weeks of pregnancy by last menstrual period, the subject had a miscarriage which was confirmed by ultrasound scan and serial human chorionic gonadotropin's.
VAERS ID: 282583   Vaccination Date: 2001-01-23
Age: 23.0   Onset Date: 2007-02-13   Days later: 2212
Gender: Female   Submitted: 2007-06-20
State:    Entered: 2007-06-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: beta-human chorionic gonadotropin (unsp) 13Feb07 Negative
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type': WAES0706PER00006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative
Write-up: Information has been received from a physician concerning a 23 year old female on 23-JAN-2001 was vaccinated with Gardasil. There was no concomitant medication. On 13-FEB-2007 the patient experienced spontaneous abortion. The reporter felt that spontaneous abortion was an other medical event and was not related to therapy with Gardasil. No further information is available.
VAERS ID: 282914   Vaccination Date: 2007-01-30
Age: 24.0   Onset Date: 2007-05-07   Days later: 97
Gender: Female   Submitted: 2007-06-26
State:    Entered: 2007-06-27
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: NONE
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type': WAES0706PER00010
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
Write-up: Information has been received from a physician concerning a 24 year old female who on 30-JAN-2007 was vaccinated with Gardasil. There was no concomitant medication. On 07-MAY-2007 the patient experienced spontaneous abortion and was hospitalized. Subsequently, the patient recovered from spontaneous abortion. No further information is available.
VAERS ID: 288910   Vaccination Date: 2007-01-31
Age: 26.0   Onset Date: 2007-02-01   Days later: 1
Gender: Female   Submitted: 2007-08-23
State:    Entered: 2007-08-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 12Feb07)
Diagnostic Lab Data: urine beta-human chorionic gonadotropin 30Mar07 Comment: positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0708USA03951
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a physician concerning a 26 year old female who on 31-JAN-2007 was vaccinated intramuscularly with Gardasil. In February 2007, the patient experienced vaccine exposure during pregnancy (date of last menstrual period was 12-FEB-2007/urine pregnancy test positive on 30-MAR-2007). The patient had two previous pregnancies with two live births. The second dose of Gardasil was interrupted. It was reported that the patient was in good condition. On 17-APR-2007 the patient experienced a spontaneous abortion. The reporter felt that the vaccine exposure during pregnancy was not related to therapy with Gardasil and the spontaneous abortion was probably not related to therapy with Gardasil. Upon internal review, the spontaneous abortion was felt to be an other important medical event. No further information is available.
VAERS ID: 289681   Vaccination Date: 2007-06-02
Age: 22.0   Onset Date: 2007-08-17   Days later: 76
Gender: Female   Submitted: 2007-08-31
State:    Entered: 2007-09-04
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0708COL00012
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a physician concerning a female who was placed on therapy with Gardasil (dose, duration and indication not reported). Subsequently the patient experienced vaccine exposure during pregnancy. On 17-AUG-2007 patient had a spontaneous abortion. The reporting felt the spontaneous abortion is not related to the Gardasil. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information is not expected.

 

VAERS ID: 290178   Vaccination Date: 0000-00-00
Age: 36.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-09-07
State:    Entered: 2007-09-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0709USA00143
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a health authority concerning a 36 year old female who, on an undisclosed date, was vaccinated with MMR II, lot number and manufacturer not reported) in her third week of gestation. Six weeks post vaccination, in her ninth week of gestation, the patient aborted spontaneously. The reason for the abortion was unknown. No further information is available. The case is closed. Other business partner number includes: E2007-05713. No further information is available. The case is closed.
VAERS ID: 290582   Vaccination Date: 2007-07-31
Age: 17.0   Onset Date: 2007-07-31   Days later: 0
Gender: Female   Submitted: 2007-09-13
State:    Entered: 2007-09-14
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0709USA01406
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a healthcare professional, concerning a 17 year old female patient who was unknowingly pregnant when vaccinated on 31-JUL-2007 with the first dose of Gardasil (lot # not provided). On 03-AUG-2007, it was determined that she was pregnant. On 14-AUG-2007 she had a spontaneous abortion. She completely recovered (date, duration and details not provided). The event of spontaneous abortion was considered to be serious as an other important medical event. This file is closed. Other business partner numbers included: E2007-05931.
VAERS ID: 291370   Vaccination Date: 2007-01-31
Age: 26.0   Onset Date: 2007-02-01   Days later: 1
Gender: Female   Submitted: 2007-09-25
State:    Entered: 2007-09-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 12Feb07)
Diagnostic Lab Data: urine beta-human chorionic gonadotropin 30Mar07 positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0704PER00006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a physician concerning a 26 year old female who on 31-JAN-2007 was vaccinated with Gardasil. In February 2007, the patient experienced vaccine exposure during pregnancy and no adverse effect (Patient had two previous pregnancies). No action was taken regarding the therapy with Gardasil but schedule for the second dose was interrupted. Patient was in good conditions. On 17-APR-2007 patient experienced spontaneous abortion. The reporter considered the spontaneous abortion an OME. The reporter felt that vaccine exposure during pregnancy was not related and spontaneous abortion was probably not related to therapy with Gardasil. No further information is expected. This is a consolidation of two reports concerning the same patient.
VAERS ID: 291813   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-10-01
State:    Entered: 2007-10-02
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0709USA04507
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a pharmacist, concerning an adult female patient (age not specified), who was in the early stages of pregnancy and was vaccinated on an unknown date with the first dose of Gardasil (lot # not provided). Subsequently the patient experienced a spontaneous abortion. At the time of this report, the patient had recovered from the event. The reporter considered spontaneous abortion to be serious as an other important medical event. Other business partner numbers include: E2007-06321.
VAERS ID: 292237   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2007-10-04
State:    Entered: 2007-10-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0709USA04283
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a pharmacist concerning an adult female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil in early pregnancy. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced a spontaneous abortion. Subsequently on an unspecified date, the patient recovered from spontaneous abortion. Spontaneous abortion was considered to be an other important medical event. Other business partner numbers included E2007-06321. Additional information is not expected.
VAERS ID: 293406   Vaccination Date: 2007-08-17
Age: 20.0   Onset Date: 2007-09-01   Days later: 15
Gender: Female   Submitted: 2007-10-16
State:    Entered: 2007-10-17
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness:
Diagnostic Lab Data: gynecological examination 13Sep07 uterine dilation and curettage 02Oct07
Previous Vaccinations:
Other Medications: Imiquimod
Preexisting Conditions: Condyloma
CDC 'Split Type': WAES0709HUN00011
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Gynaecological examination, Haemorrhage, Pregnancy test positive, Uterine dilation and curettage
Write-up: Information has been received from a physician concerning a 20 year old female with a history of condyloma previously treated with ALDARA who on 17-AUG-2007 was vaccinated with Gardasil. On 05 September 2007 the patient reported that she missed her menstrual period. Pregnancy test proved positive. On 13 September 2007 gynaecological examination also confirmed the pregnancy. No contraception method was used. Patient is planning to give birth to the baby. This is the first pregnancy of the patient. The patient is planned to be vaccinated with the second and third dose of Gardasil following delivery, during lactation. Follow-up information received on 10 October 2007. Patient had a spontaneous abortion on 02 October 2007. Patient was hospitalized due to intensive bleeding where uterine dilation and curettage was performed. The reporter felt that spontaneous abortion was not related to therapy with Gardasil. Additional information is not expected.
VAERS ID: 298175   Vaccination Date: 2007-09-07
Age: 19.0   Onset Date: 2007-11-19   Days later: 73
Gender: Female   Submitted: 2007-11-28
State:    Entered: 2007-11-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 18Aug07)
Diagnostic Lab Data: beta-human chorionic gonadotropin (unsp) Comment: positive
Previous Vaccinations:
Other Medications: folic acid
Preexisting Conditions:
CDC 'Split Type': WAES0710CAN00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Write-up: Information has been received from a nurse concerning a 19 year old white female with a history of 0 pregnancies and 0 live births who on approximately 07-SEP-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included folic acid. In September 2007, the patient experienced found out she is pregnant. The patient had a positive pregnancy test. The patient last menstrual date was on 18-AUG-2007. On approximately 19-NOV-2007 the patient experienced spontaneous abortion. Upon internal review, spontaneous abortion was considered to be another important medical event. No further information is available.
VAERS ID: 300631   Vaccination Date: 2007-06-15
Age: 33.0   Onset Date: 2007-07-30   Days later: 45
Gender: Female   Submitted: 2007-12-18
State:    Entered: 2007-12-20
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnant, LMP date: 30/MAY/07; sex: female
Diagnostic Lab Data: The patient had an ultrasound on 31 July 2007, which had an abnormal result of a blighted ovum.
Previous Vaccinations:
Other Medications:
Preexisting Conditions: The patient's past obstetric history included one (1) previous pregnancy, which resulted in one (1) live birth with no congenital anomalies, elective abortions, spontaneous abortion or fetal deaths.
CDC 'Split Type': 200702326
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Blighted ovum, Drug exposure during pregnancy, Ultrasound scan abnormal
Write-up: Seriousness criteria: other - medically significant. Initial report received on 27 June 2007 from a consumer, who is the patient. A female patient received on 15 June 2007 a dose of Adacel (lot # not reported). She reported that her period was 2 weeks late, therefore she conceived just before administration of Adacel. No adverse event was reported. No other information was provided. Follow-up information received from the patient on 14 December 2007. The authorization and completed pregnancy report form were received. The patient's past obstetric history included one (1) previous pregnancy, which resulted in one (1) live birth with no congenital anomalies, elective abortions, spontaneous abortions or fetal deaths. The patient's last menstrual period was 30 May 2007 and her estimated date of delivery was 05 March 2008. She experienced a miscarriage on 30 July 2007 that she considered as spontaneous abortion (less than 20 weeks gestation). The patient had an ultrasound on 31 July 2007, which had an abnormal result of a blighted ovum. Medical assessment: Spontaneous abortions occur commonly during the 1st trimester. These are usually due to pre-existing chromosomal abnormalities. The relationship to exogenous factors such as vaccination is unlikely.
VAERS ID: 303071   Vaccination Date: 2007-11-26
Age: 30.0   Onset Date: 2008-01-02   Days later: 37
Gender: Female   Submitted: 2008-01-21
State:    Entered: 2008-01-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: Scan normal
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': b0500292a
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     UN LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Nervousness, Scan
Write-up: This case was reported by a physician and described the occurrence of spontaneous abortion in a 30-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline). On 26 November 2007, the subject received unspecified dose of Havrix (unknown, lot number not provided) at unspecified time of her pregnancy. On unspecified date, the subject experienced nervousness and a scan was performed. The subject was scanned normally: double test, neck flexure and deformity scan. Follow up information received on 10 January 2008: On 2 January 2008, the subject experienced spontaneous abortion. This case was assessed as medically serious by manufacturer.
VAERS ID: 303187   Vaccination Date: 0000-00-00
Age:    Onset Date: 2008-01-01   Days later:
Gender: Female   Submitted: 2008-01-18
State:    Entered: 2008-01-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0801AUS00088
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a female who in 2007 was vaccinated with the first and second dose of Gardasil. In approximately January 2008 ("recently"), the patient had a miscarriage after having the second injection of Gardasil. Upon internal medical review a miscarriage after having the second injection of Gardasil was considered to be an other important medical event. Additional information has been requested.

 

VAERS ID: 308830   Vaccination Date: 2007-12-17
Age: 22.0   Onset Date: 2008-03-17   Days later: 91
Gender: Female   Submitted: 2008-04-01
State:    Entered: 2008-04-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 15Jan08)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0803USA04650
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous
Write-up: Information has been received from a health professional concerning a 22-year-old female with an unknown medical history, no previous pregnancy and no previous abortion who had received a dose of MMR (batch number not reported) on 17-DEC-2007 by the attending physician who was not the reporter. It was subsequently discovered that the patient was pregnant and the beginning of the pregnancy was determined to be on 29-JAN-2008. The last menstrual period dated back to 15-JAN-2008. On 17-Mar-2008, there was a spontaneous termination of pregnancy. Upon internal review, spontaneous abortion was considered to be an other important medical event. Other business partner numbers include E2008-02216. Additional information is not expected. This case is closed.
VAERS ID: 311179   Vaccination Date: 2007-12-12
Age: 19.0   Onset Date: 2008-02-01   Days later: 51
Gender: Female   Submitted: 2008-04-28
State:    Entered: 2008-04-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0804USA05026
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from the Merck pregnancy registry for GARDASIL from a physician concerning a 19 year old female who on 17-OCT-2007 was vaccinated with a first dose of GARDASIL. On 12-DEC-2007, the patient was vaccinated with a second dose of GARDASIL. In early February 2008, the patient became pregnant. In March 2008, the patient had a spontaneous abortion and was hospitalized. The reporting physician considered spontaneous abortion to be an other important medical event. No further details were provided. Other business partner numbers included E2008-03825.
VAERS ID: 311265   Vaccination Date: 2008-02-27
Age:    Onset Date: 2008-02-27   Days later: 0
Gender: Female   Submitted: 2008-04-29
State:    Entered: 2008-04-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 17Feb08)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: unknown
Preexisting Conditions:
CDC 'Split Type': WAES0803CAN00084
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a female who on 27-FEB-2008 was vaccinated with GARDASIL, first dose, lot # not available. On 19-MAR-2008 the patient found out that she was pregnant. The patient reported that the first day of her last menstrual cycle was 17-FEB-2008. The estimated date of delivery is 23-NOV-2008. Additional information was received on 23-APR-2008: the patient suffered a miscarriage on 21-APR-2008. She was about 9 weeks along in her pregnancy at the time. On 21-APR-2008 the patient recovered from pregnant. Upon internal review, miscarriage was considered to be another important medical event. No further information is available.
VAERS ID: 315514   Vaccination Date: 2007-04-05
Age: 31.0   Onset Date: 2007-05-11   Days later: 36
Gender: Female   Submitted: 2008-06-06
State:    Entered: 2008-06-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Abortion spontaneous
CDC 'Split Type': WAES0707USA00948
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR MERCK & CO. INC.     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a health professional concerning a 31 year old female who on an unspecified date in 2007 was vaccinated intramuscularly with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (batch #, lot#, route and site of administration not reported). The patient became pregnant 3 weeks after vaccination. No adverse effect was reported. Follow-up information received on 22-Aug-2007. It was reported that the woman was 31 years old at the time of the vaccination on 05-Apr-2007, LMP was 11-May-2007, 5 weeks post vaccination. No adverse effect reported. Relevant history included that the woman had 1 child, after an uncomplicated pregnancy, and 1 spontaneous abortion. Follow-up information received on 30-MAY-2008: The patient had an early spontaneous abortion before week 12. The patient had one spontaneous abortion previously. Case is closed. Other business partner numbers included: E2007-04267.
VAERS ID: 315983   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-06-10
State:    Entered: 2008-06-11
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP =Unknown)
Diagnostic Lab Data: ultrasound, pathological findings in fetus; amniocentesis, karyotype was normal
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0806USA00526
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Amniocentesis normal, Drug exposure during pregnancy, Foetal disorder, Karyotype analysis normal, Ultrasound antenatal screen abnormal
Write-up: Information has been received from a gynaecologist concerning a female patient who in her 10th week of pregnancy, was vaccinated with a third dose of GARDASIL (lot number, injection site and route not reported). No detailed information was provided about the first and second dose of vaccination. In the 17th week of pregnancy the patient experienced a spontaneous abortion with a foetus who had a gastroschisis. The patient was hospitalized. Due to pathological findings of the fetus in ultrasonography, an amniocentesis was performed. The karyotype of the child was normal. The outcome was not reported. Other business partner numbers include E200804946. Additional information has been requested.
VAERS ID: 318499   Vaccination Date: 2008-05-31
Age: 17.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-07-07
State:    Entered: 2008-07-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: ALDARA
Preexisting Conditions:
CDC 'Split Type': WAES0807USA00520
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Anogenital warts, Drug exposure during pregnancy, Haemorrhage
Write-up: Information has been received from a gynaecologist concerning a 17 year old female who started a spontaneous pregnancy (estimated conception date: 25-MAY-2008) 6 days before receiving the third dose, on 31-MAY-2008, of GARDASIL (Lot#, batch # and route of administration not reported). She had received the first and second doses in December 2007 and February 2008. The patient was concomitantly treated with ALDARA for vulvar condylomae she probably had since February 2008 and were noticed in May 2008. The patient had stopped contraception. ON 10-MAY-2008, she experienced miscarriage followed by bleeding lasting 5 to 6 days. It was also reported that the patient had unprotected sexual intercourse on 25-MAY-2008. She was seen by her gynaecologist on 25-JUN-2008 due to her positive pregnancy test on 17-JUN-2008. She was then approximately one month pregnant (WAES # 0806USA08890). No adverse reaction was reported. Upon internal review, miscarriage was determined to be an other important medical event. Further information is expected. Other business partner numbers included: E2008-05982. Additional information has been requested.
VAERS ID: 320386   Vaccination Date: 2007-08-28
Age: 27.0   Onset Date: 2007-08-28   Days later: 0
Gender: Female   Submitted: 2008-07-24
State:    Entered: 2008-07-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Current Illness: Unknown
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: Metformin hydrochloride
Preexisting Conditions: HYPERPROLACTINAEMIA, PITUITARY ADENOMA, POLYCYSTIC OVARIAN SYNDROME
CDC 'Split Type': B0485744A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV UNKNOWN MANUFACTURER     UN UN
HEPA GLAXOSMITHKLINE BIOLOGICALS ATYAB012AA   IM UN
TYP UNKNOWN MANUFACTURER ATYAB012AA   IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: This case was reported by a nurse and described the occurrence of drug exposure during pregnancy in a 27-year-old female subject who was vaccinated with HEPATYRIX (GlaxoSmithKline). The subject's medical history included pituitary adenoma and polycystic ovarian syndrome. Concurrent medications included REVAXIS. On 28 August 2007 the subject received unspecified dose of HEPATYRIX (intramuscular). The nurse reported that four days later the patient took a pregnancy test that showed positive. Follow up received 15 July 2008: Patient details were updated. LMP was reported as 25 July 2007 and EED was reported as 1 May 2008. It was reported that the patient never smoked. Medical history included Hyperprolactinaemia. Concurrent medication included Metformin. On 3 October 2007 the patient experienced miscarriage. The event was serious because the patient required hospitalisation. Please see case B0485744B for baby case.
VAERS ID: 323066   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-08-22
State:    Entered: 2008-08-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: Unk
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0533728A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: This case was reported by a physician and described the occurrence of miscarriage in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (injection). At an unspecified time after vaccination with HAVRIX, the subject experienced miscarriage. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved.
VAERS ID: 323709   Vaccination Date: 0000-00-00
Age: 26.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-08-22
State:    Entered: 2008-08-29
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP=Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0808AUS00257
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.     UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been obtained by the Company from the agency via a Case Line Listing, concerning a 26 year old female who was vaccinated with GARDASIL. Subsequently, 49 days post-vaccination, the patient experienced a complete spontaneous abortion. At the time of reporting to the agency on 07-MAR-2008 the patient had recovered from complete spontaneous abortion. The agency considered that complete spontaneous abortion was related to therapy with GARDASIL. The original reporting source was not provided by the agency. The agency considered complete spontaneous abortion to be serious for the following reason: medically significant. Additional information is not expected.
VAERS ID: 323973   Vaccination Date: 2007-11-02
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2008-09-02
State:    Entered: 2008-09-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 19Oct07)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Preexisting Conditions:
CDC 'Split Type': WAES0808USA05119
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Contraception, Drug exposure during pregnancy
Write-up: Information has been received from a physician concerning a female who was vaccinated with her second dose of GARDASIL (Lot number not reported) into the deltoid muscle on 02-NOV-2007. Despite use of unspecified hormonal contraceptives the patient fell pregnant. The date of her last menstrual period was on 19-OCT-2007. The patient had a spontaneous abortion after 6 to 8 week (exact date could not be provided by the physician). No hospitalization. Spontaneous abortion was considered to be an other medical important event. Other business partner numbers included: E2008-07954. No further information is available.

 

VAERS ID: 324286   Vaccination Date: 2008-06-03
Age: 21.0   Onset Date: 2008-05-07   Days later: -27
Gender: Female   Submitted: 2008-09-04
State:    Entered: 2008-09-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: ultrasound, 23Jul08, no signs of fetal vitality
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Legally induced abortion
CDC 'Split Type': WAES0807USA00996
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Echography abnormal, Ultrasound scan abnormal
Write-up: This is a case of pregnancy follow-up reported by a specialist through the Sanofi Pasteur Pregnancy Registry on 01-Jul-2008. A female patient started a spontaneous pregnancy on 21-May-2008 (estimated conception date) and received the third dose injection of GARDASIL (batch number not reported) in the first week of June 2008. Her last menstrual period was on 07-MAY-2008. At the time of reporting the patient had no adverse effect. Follow-up information received from the specialist through the Sanofi Pasteur MSD Initial Questionnaire of Pregnancy Registry: Case upgraded to serious as the patient had a spontaneous abortion (OME). Patient's date of birth and weight were completed. An echography performed on 23-JUL-2008 showed no signs of fetal vitality. On 27-JUL-2008 she experienced a spontaneous abortion. The patient had a medical history of legally induced abortion in 2007. Other business partner numbers include E2008-06142. The case is closed. No further information is available.
VAERS ID: 324391   Vaccination Date: 2005-01-25
Age: 25.0   Onset Date: 2005-02-14   Days later: 20
Gender: Female   Submitted: 2008-09-05
State:    Entered: 2008-09-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Delivery of baby, miscarriages
CDC 'Split Type': A0744983A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   1 IM LA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous complete, Drug exposure during pregnancy, Oral contraception, Pregnancy test positive, Vaginal haemorrhage
Write-up: This 25-year-old female subject was enrolled in a blinded study (580299 009). The subject received intramuscular investigational product single dose on 13 December 2004 and 25 January 2005, after negative urine pregnancy tests and she did not receive the 3rd dose. Site of injection was the left deltoid. On 13 December 2004 and 25 January 2005, the subject received the 1st and 2nd dose of intramuscular injection of blinded study vaccine in the left deltoid, after negative urine pregnancy tests and she did not receive the 3rd dose. The subject had been randomized to receive the active control in this trial, an investigational formulation of HAVRIX vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug Al(OH)3. Lot number was not provided. The subject's past medical history included 5 previous pregnancies resulting in 1 delivery of baby and 4 miscarriages. This was the subject's first pregnancy after enrolling in the study and she later had a second pregnancy during the study that resulted in a spontaneous complete abortion on 20 May 2007 (see case B0470824A for further details). Her last menstrual period occurred on 05 January 2005 (approximate date) and she was exposed to the vaccine before conception and also during the first trimester of her pregnancy. Before becoming pregnant she used oral contraceptives as a form of birth control which she stopped taking in February (during her first trimester) when in consultation a blood pregnancy test resulted positive. She did not initiate prenatal care. On 14 February 2005, 20 days after the 2nd dose of Blinded vaccine and within an unspecified timeframe in February when she took oral contraceptives (during the first trimester), this 25-year-old subject experienced an abortion spontaneous complete. The event was clinically significant (or requiring intervention). The event resolved on 15 February 2005. The investigator reported the abortion spontaneous complete as possibly related to investigational product because of the temporal relationship
VAERS ID: 325474   Vaccination Date: 2008-05-13
Age: 34.0   Onset Date: 2008-07-18   Days later: 66
Gender: Female   Submitted: 2008-09-17
State:    Entered: 2008-09-18
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 21Apr08)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0806USA08885
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1208U 2 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Write-up: Information has been received from a physician, concerning a 34 year old female patient, with no previous medical history reported, who on 13-MAY-2008 received the third dose of GARDASIL (Lot # 1208U and batch # NH13360). One week after vaccination the patient started a pregnancy. She was vaccinated at 3 weeks of amenorrhea as the starting date of her last menstruation periods was 21-APR-2008. No adverse reaction was reported. Follow-up information was received from a physician, through the Sanofi Pasteur MSD GARDASIL pregnancy registry, which reported that this is a case of pregnancy. This is also a case of misuse, ie vaccine administered beyond recommended age. Follow-up information was received from a physician, through the Sanofi Pasteur MSD GARDASIL pregnancy questionnaire, which reported that the case was upgraded to serious on 18-JUL-2008, the patient experienced a spontaneous abortion. Spontaneous abortion was considered to be an other important medical event. Other business partner numbers included: E2008-05313. No further information is available.
VAERS ID: 327202   Vaccination Date: 2008-08-08
Age: 41.0   Onset Date: 2008-08-13   Days later: 5
Gender: Female   Submitted: 2008-10-06
State:    Entered: 2008-10-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0538944A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS     UN UN
IPV UNKNOWN MANUFACTURER     UN UN
TD UNKNOWN MANUFACTURER     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: This case was reported by a consumer and described the occurrence of spontaneous abortion in a 41-year-old female subject who was vaccinated with HAVRIX adult (GlaxoSmithKline), Td-IPV. On 8 August 2008, the subject received unspecified dose of HAVRIX adult (unknown route and injection site), unspecified dose of Td-IPV (unknown route and injection site). The lot numbers were not provided. On 13 August 2008, 5 days after vaccination with Td-IPV and HAVRIX adult, the subject experienced spontaneous abortion after 8 weeks of pregnancy. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved. The physician considered the event was unrelated to vaccination with Td-IPV and HAVRIX adult.
VAERS ID: 327726   Vaccination Date: 2008-07-07
Age: 23.0   Onset Date: 2008-07-07   Days later: 0
Gender: Female   Submitted: 2008-10-08
State:    Entered: 2008-10-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Current Illness: Pregnancy NOS (LMP = 04Jul08)
Diagnostic Lab Data: ultrasound, 28Aug08, 6 weeks pregnancy, live embryo
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0809MEX00009
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan, Uterine dilation and curettage
Write-up: Information has been received from a physician concerning a female who in 2008 was vaccinated with GARDASIL. At the time of the report the patient has received two doses to GARDASIL. On 25-AUG-2008 the patient informed to the physician to be pregnant. HPV vaccine dose 3 was not administered. Pregnancy outcome is unknown. After several attempts no further details could be obtained. On 29-SEP-2008 additional and clarification information was received from the physician who confirmed that the patient is a 23 year old female with a history of 0 pregnancies and 0 live births who on 07-JUL-2008 was vaccinated with GARDASIL (only first dose of vaccine received). No concomitant therapy. Last menstrual period occurred on 04-JUL-2008. On 28-AUG-2008 pregnancy was confirmed through agency that reported pregnancy with 6 weeks live embryo. On 18-SEP-2008 the patient experienced abortion spontaneous and was hospitalized to perform curettage. The patient was discharged on 19-SEP-2008 recovered and without complications. The physician stated that he could not define if abortion spontaneous was related or no with GARDASIL. Additional information is not expected.
VAERS ID: 333232   Vaccination Date: 2008-10-02
Age: 23.0   Onset Date: 2008-09-23   Days later: -9
Gender: Female   Submitted: 2008-11-20
State:    Entered: 2008-11-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 01Sep08)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0810CAN00093
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a nurse concerning a 23 year old female who on 02-OCT-2008 was vaccinated with the first dose of GARDASIL, lot # not available. The patient's last menstrual period was on 01-SEP-2008. On 23-SEP-2008 the patient had a pregnancy test done which showed a weak positive result. The nurse reported that the medical student who asked her to give the vaccine was not aware of the previous result. The nurse reported that the patient indicated that on 02-OCT-2008 she had not known she was pregnant for sure. On 20-OCT-2008 the nurse reported that another blood test would be done to confirm/re-confirm pregnancy. The estimated date of delivery is 08-JUN-2009. Additional information has been received from the nurse on 12-NOV-2008. It was reported that the patient was 10 weeks pregnant. Additional information has been received from the nurse on 14-NOV-2008. The patient informed her that she had a spontaneous abortion (no further details available). The patient recovered from pregnancy test done which showed a weak positive result and spontaneous abortion. Upon internal review, spontaneous abortion was considered to be an other important medical event. No further information is available.
VAERS ID: 334154   Vaccination Date: 2005-04-12
Age: 23.0   Onset Date: 2008-06-30   Days later: 1175
Gender: Female   Submitted: 2008-12-08
State:    Entered: 2008-12-08
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Asthma; Gastroesophageal reflux disease; Occasional hip pain on movement
Diagnostic Lab Data: Pregnancy test urine, 13Jun2008, +pregnancy
Previous Vaccinations:
Other Medications: Esomeprazole; ORTHO TRI-CYCLEN; Cyclobenzaprine HCl; MIN-OVRAL; SYMBICORT
Preexisting Conditions: Motor vehicle accident
CDC 'Split Type': A0756322A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS DVHA819B9   IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain lower, Abortion spontaneous, Back pain, Drug exposure during pregnancy, Menorrhagia, Pregnancy test urine positive
Write-up: This female subject was enrolled in the prophylactic double blind study 580299/008. On 09 October 2004, 18 November 2004 and 12 April 2005, the subject received the 1st, 2nd and 3rd dose of HPV (IM deltoid) or HAVRIX, 720 EU, (IM deltoid). On 10 September 2008, the subject received a dose of antitetanic vaccine. The subject received HAVRIX (lot 3 : DVHA819B9). The subject's past medical history included motor vehicle accident. Medical conditions at the time of the event included asthma, gastroesophageal reflux disease and occasional left hip pain on movement. Concomitant medications included TRICYCLEN 21, SYMBICORT, NEXIUM, MINOVRAL 21 and FLEXERIL. The subject's past medical history included no previous pregnancy. The subject did not use a contraception method. Her last menstrual period occurred on 09 May 2008. The subject was exposed to the vaccine before conception. The estimated delivery date was unknown. On 30 June 2008, three years after the 3rd dose of HAVRIX, this 26-year-old subject experienced spontaneous abortion after unknown weeks of gestation. The event was clinically significant (or requiring intervention). The event resolved on 30 June 2008. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by HAVRIX. Investigator comments on 13 November 2008: Menses occurred on 09 June 2008. Emergency Room visit on 13 June 2008: lower left quadrant pain, urine pregnancy test weak positive, menses continued. On 30 June 2008: heavy menses with low back and abdominal pain, spontaneous abortion, resolution of menses. No further medical attention. Additional information received on 28 November 2008: The investigator first considered the event to be not related to the vaccine. As of 28 November 2008, at time of this report, the investigator finally stated that the event was possibly related to the study vaccination. Additional information received on 03 December 2008: The investigator believes he cannot rule out 100% that it was not caused by the stud
VAERS ID: 335714   Vaccination Date: 2008-09-24
Age: 17.0   Onset Date: 2008-09-24   Days later: 0
Gender: Female   Submitted: 2008-12-19
State:    Entered: 2008-12-19
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': B0551063A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP GLAXOSMITHKLINE BIOLOGICALS AHBVB256BB   IM LA
IPV UNKNOWN MANUFACTURER A11371   IM UN
MEN UNKNOWN MANUFACTURER XA0013A   IM UN
MMR UNKNOWN MANUFACTURER NH42300   IM UN
TD GLAXOSMITHKLINE BIOLOGICALS AC12B020AA   IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: This case was reported by regulatory authority (regulatory authority # L200810-669) and described the occurrence of spontaneous abortion on a 17-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline), MMR vaccine (non-gsk), meningococcal polysaccharide vaccine group c (non-gsk), DITANRIX and poliomyelitis vaccine inactivated (non-gsk). The subject didn't have any immunization registry. The history of adverse events to previous drugs was unknown. On 24 September 2008, the subject received 1st dose of ENGERIX B (intramuscular, unknown injection site), 1st dose of MMR vaccine (Non-GSK) (intramuscular, unknown injection site), 1st dose of Meningococcal polysaccharide vaccine group C (Non-GSK) (intramuscular, unknown injection site), 1st dose of DITANRIX (intramuscular, unknown injection site), 1st dose of poliomyelitis vaccine inactivated (Non-GSK) (intramuscular, unknown injection site). The date of last menstruation period was 25 August 2008. On 24 October 2008, the subject took a pregnancy test which came out positive. At the time of vaccination, the subject was 4 weeks and 2 days pregnant. An appointment scheduled with maternal health on 28 November 2008. On 10 November 2008, the subject experienced a spontaneous abortion. She had an appointment with family planning on 19 November 2008. The subject didn't perform a physical activity or have an abdominal trauma. The possibility of an administration of an abortive medication was not referred or detectable. The subject was not given an explanation related to the abortion. The spontaneous abortion was the only adverse event noted. This case was assessed as medically serious by GSK. The subject went to the family planning appointment and is going to start oral contraceptive pills (ETHINYLESTRADIOL + GESTODENE) in the next menstrual cycle. Condoms were provided. The subject was supposed to be vaccinated with the other vaccines missing at the beginning of December.
VAERS ID: 336055   Vaccination Date: 2008-09-24
Age: 17.0   Onset Date: 2008-09-24   Days later: 0
Gender: Female   Submitted: 2008-12-23
State:    Entered: 2008-12-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 25Aug08)
Diagnostic Lab Data: Beta-human chorionic gonadotropin (unsp), 24Oct08, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0812USA04204
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTOX UNKNOWN MANUFACTURER     IM UN
HEP MERCK & CO. INC.     IM UN
IPV UNKNOWN MANUFACTURER     IM UN
MMR MERCK & CO. INC. 0945U   IM UN
TTOX UNKNOWN MANUFACTURER     IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a case of pregnancy follow-up form received from the foreign Health Authorities (Infarmed, reference number (200810-669) concerning a 17 year old female with no medical history who on 24-SEP-2008 was vaccinated with MMR II (batch number NH42300; lot # 657533/0945U) intramuscularly. Secondary suspect therapy on 24-SEP-2008 included RECOMBIVAX HB, poliovirus vaccine, tetanus toxoid, meningococcal vaccination register document. In accordance with foreign Immunization plan the patient had received the five vaccines. The patient had signed a declaration stating that she was not pregnant. On 24-OCT-2008 the patient had done a pregnancy test and the results was positive. The patient was then referred to a complementary visit, in order to be transferred to a hospital. At the hospital, an obstetrics visit was scheduled to be transferred to a hospital. At the hospital, an obstetrics visit was scheduled for 28-NOV-2008. It was unknown whether there was any history of previous adverse reactions to any other drugs. At the time of the report, the outcome was unknown. On 12-NOV-2008 it was reported that the patient had a spontaneous abortion on 10-NOV-2008. It was reported on 09-DEC-2008 that it was calculated that on 24-SEP-2008 the day of the vaccine's exposure the patient had been 4 weeks and 2 days pregnant, judging from the first day of the last menses period on 25-AUG-2008. The patient denied having had physical exercise and abdominal trauma before the spontaneous abortion and also denied having taken any abortive medication which was not detectable. At the hospital according to the patient's report no explanations were given to the patient regarding the abortion. The patient was just told that she was having a spontaneous abortion and that it was "usual to happen". No other adverse reaction besides the spontaneous abortion occurred. The patient came to the family planning visit and will start oral contraception with ethynilestradiol and gestodene in the next menstrual cycle. Condons hav
VAERS ID: 340662   Vaccination Date: 2009-01-06
Age: 26.0   Onset Date: 2009-01-26   Days later: 20
Gender: Female   Submitted: 2009-02-24
State:    Entered: 2009-02-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: Abortion induced
CDC 'Split Type': WAES0902HKG00001
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 IM UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a health professional (clinic nurse) concerning a 26 year old female with a history of induced abortion 6 years ago who on 06-JAN-2009 was vaccinated with second dose of GARDASIL (with the first dose received on 25-OCT-2008). There was no concomitant medication. After vaccination with the second dose, the patient was found to be pregnant and subsequently, the patient experienced accidental miscarriage on approximately 26th January 2009 when she traveled outside foreign country. The doctor felt that this was an individual case and was not related to administration of GARDASIL. Accidental miscarriage is considered to be an other important medical event. Since the patient was not followed up by the doctor, no further information is available.

 

VAERS ID: 344300   Vaccination Date: 2008-09-16
Age: 28.0   Onset Date: 2008-11-01   Days later: 46
Gender: Female   Submitted: 2009-04-10
State: Florida   Entered: 2009-04-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: None Clinical Research Trial
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU SANOFI PASTEUR U2532AA 1 IM LA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain, Abortion spontaneous, Vaginal haemorrhage
Write-up: Received FLUZONE vaccine on 9/16/08. November (date unknown) patient developed abdominal cramps & vaginal bleeding. OB/GYN evaluation revealed a spontaneous miscarriage.
VAERS ID: 344513   Vaccination Date: 2008-12-06
Age: 20.0   Onset Date: 2008-12-06   Days later: 0
Gender: Female   Submitted: 2009-04-20
State: Unknown   Entered: 2009-04-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/1/2009)
Diagnostic Lab Data: None
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0904USA01725
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0651X 1 SC UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Incorrect route of drug administration
Write-up: Information has been received from a registered nurse concerning a 20 year old female with no past drug history, who on 06-DEC-2008 was vaccinated with a 0.5 mL second dose of GARDASIL (lot # 661703/0651X), subcutaneously. There was no concomitant medication. It was reported that in January 2009 the patient had a pregnancy. On 23-MAR-2009 the patient had a spontaneous abortion. There were no laboratory studies performed. On 11-APR-2009 the patient received her third dose of GARDASIL. Follow up information received on 16-APR-2009 from a registered nurse stated that the patient received the first dose of GARDASIL on 03-AUG-2008; second dose on 06-DEC-2008 (lot # 661703/0651X) and third dose on 11-APR-2009 (lot # 661846/1312X). There was no mention of pregnancy at the time of the 06-DEC-2008 dose (second dose). The LMP date was not indicated in the chart, nor was the # of weeks from LMP to the time of the spontaneous abortion (not an elective termination). Also not indicated in the notes was whether or not the products of conception were examined. This was the patient's first pregnancy. Upon internal review spontaneous abortion was determined to be an other important medical event. No further information is available.
VAERS ID: 344763   Vaccination Date: 2007-06-18
Age: 31.0   Onset Date: 2007-06-18   Days later: 0
Gender: Female   Submitted: 2009-04-23
State:    Entered: 2009-04-24
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 23May07)
Diagnostic Lab Data: ultrasound, scan at 11 weeks gestation and the baby had died at 5 weeks gestation
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0708USA02360
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV PASTEUR MERIEUX INST.     UN UN
HEPA MERCK & CO. INC.     UN UN
TYP UNKNOWN MANUFACTURER     UN UN
YF UNKNOWN MANUFACTURER A53238   UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Intra-uterine death, Ultrasound scan abnormal
Write-up: Information has been received from a health care professional concerning a 31 year old pregnant female who on approximately 18-JUN-2007 was vaccinated with VAQTA (Manufacturer unknown). Concomitant therapy included STAMARIL (Batch #A5323-8), REVAXIS and typhoid vaccine (manufacturer unknown). Following the vaccinations the patient was found to be pregnant at approximately three weeks gestation at the time of STAMARIL vaccination. The last menstrual period was 23-MAY-2007. There was no other history reported. There was no adverse effect reported. Follow-up information received from a health care professional on 17-APR-2009. This case has been upgraded from non serious to serious. The patient weighed 89kg. The patient had no maternal risk factors and no recreational drug use. There were no previous pregnancies. The patient did not receive any fertility treatment. The patient underwent a scan at 11 weeks gestation and was informed that the baby had died at five weeks gestation. The patient then experienced a miscarriage in July 2007. The reporter considered the events to be serious. Other business partner numbers include E200704347 and 55997.
VAERS ID: 345039   Vaccination Date: 2007-06-18
Age: 31.0   Onset Date: 2007-07-01   Days later: 13
Gender: Female   Submitted: 2009-04-27
State:    Entered: 2009-04-28
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Pregnant, LMP date: 23/MAY/07 Sex: Female. The patient weighs 89 kg. The patient had no maternal risk factors and no recreational drug use. No previous pregnancies. The patient did not received any fertility treatment.
CDC 'Split Type': E200704347
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV SANOFI PASTEUR     UN UN
TD SANOFI PASTEUR     UN UN
YF SANOFI PASTEUR A5323   UN UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: This is a pregnancy follow up case with no adverse effect reported. This case was initially reported by a health care professional on 02-Jul-07 (no: 55997). This case concerns a 31 year old female patient. On 18-Jun-07, the patient received STAMARIL, batch number A5323-8. The patient also received REVAXIS, batch number not reported and a Hepatitis A vaccine and typhoid vaccine around the same time (exact date not reported). Following the vaccinations, the patient was found to be pregnant at approximately three weeks gestation at the time of the STAMARIL. The date of the last menstrual period was 23-May-07. Follow-up information received from a health care professional on 17-Apr-09. This case has been upgraded from non serious to serious. The patient weighs 89 kg. The patient had no maternal risk factors and no recreational drug use. There were no previous pregnancies. The patient did not received any fertility treatment. The patient underwent a scan at 11 weeks gestation and was informed that the baby had died at five weeks gestation. The patient then experienced a miscarriage in Jul-07. The reporter considered the events to be serious.
VAERS ID: 345257   Vaccination Date: 2009-03-20
Age: 23.0   Onset Date: 2009-03-20   Days later: 0
Gender: Female   Submitted: 2009-04-29
State: Texas   Entered: 2009-04-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/3/2009); Hypothyroidism
Diagnostic Lab Data: ultrasound, 04/06/09, IUP early vs MAB. Reason: spotting; ultrasound, 04/09/09, Result: Cardiac activity. Reason: spotting threatened MAB; ultrasound, 04/13/09, Result: Cardiac activity; ultrasound, 04/21/09, Result: No cardiac activity; ur
Previous Vaccinations:
Other Medications: Levothyroxine sodium, microgm
Preexisting Conditions: Ectopic pregnancy
CDC 'Split Type': WAES0904USA03645
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1129X 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Progesterone, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive, Vaginal haemorrhage
Write-up: Information has been received from a licensed visiting nurse, for the GARDASIL a Pregnancy Registry concerning a 23 year old female with hypothyroidism and a history of 3 pregnancies: 1 live birth at 39 week from LMP, 2 spontaneous abortions including an ectopic pregnancy in March 2008 (5-6 weeks from LMP), with no birth defects of infant complications in previous pregnancies who on 20-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# 661952/1129X). Concomitant therapy included levothyroxine Na. The nurse reported that the patient was pregnant. Her LMP was 03-MAR-2009 and her EDD was 08-DEC-2009. On 26-MAR-2009 the patient started spotting. The nurse stated that the patient was having heavy bleeding and was in the process of miscarrying. Laboratory tests included urine beta-human chorionic gonadotropin test and progesterone performed on 03-APR-2009. On 06-APR-2009 an ultrasound was performed due to her spotting with result intrauterine pregnancy early vs missed abortion. On the same date an urine beta-human chorionic gonadotropin test was done. Additional ultrasounds performed on 09-APR-2009 due to the patient's spotting revealed fetal cardiac activity as well on 13-APR-2009 there was fetal cardiac activity. On 17-APR-2009 the patient experienced spontaneous abortion (7 weeks from LMP), and she has chosen to wait and see if the fetus will pass on its own. It was reported that the patient has a follow up visit in 2 weeks and will have an ultrasound. If the fetus does not pass the patient will be scheduled for a dilation and curettage. On 21-APR-2009 an ultrasound revealed no fetal cardiac activity, there was no fetal heartbeat. Upon internal review in the process of miscarrying was considered to be an other important medical event. Additional information is not expected.
VAERS ID: 345697   Vaccination Date: 2009-02-05
Age: 19.0   Onset Date: 2009-02-05   Days later: 0
Gender: Female   Submitted: 2009-05-04
State: Unknown   Entered: 2009-05-05
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/25/2009); Smoker; Papilloma viral infection
Diagnostic Lab Data: ultrasound, 03/26/09, 7 weeks OB; ultrasound, 04/08/09, confirmed SAB
Previous Vaccinations:
Other Medications: FLINTSTONES MULTIVITAMIN
Preexisting Conditions: Caesarean section; Early onset of delivery
CDC 'Split Type': WAES0903USA05524
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0570X 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Nausea, Ultrasound abdomen abnormal
Write-up: Information has been received from a registered nurse concerning a 19 year old female with no medical history and no known drug allergies who on 05-FEB-2009 was intramuscularly vaccinated with a 0.5 ml dose of GARDASIL (lot #660616/0570X). Concomitant therapy included vitamins (unspecified) (FLINTSTONES MULTIVITAMIN). The patient was pregnant while received GARDASIL. Her LMP was 25-JAN-2009. No adverse effect was reported. Lab diagnostic studies included prenatal screen. The patient had an office visit for medical attention. Follow up information was received from the registered nurse who reported that the 19 year old patient was a smoker with HPV infection. She had one previous pregnancy and pre-term delivery at 35.4 weeks by caesarean section in 2008. The patient was vaccinated with the first dose of GARDASIL on 05-FEB-2009. Concomitant therapy included vitamins (unspecified) (FLINTSTONES MULTIVITAMIN) for prenatal use. The patient experienced nausea during her pregnancy and was prescribed ZOFRAN 8mg every 12 hrs on 23-MAR-2009 for treatment. Her pregnancy was confirmed by sonogram at the first OB appointment on 26-MAR-2009. She was advised to quit smoking. There was no illness during the pregnancy. The patient was seen on 03-APR-2009 with known spotting. The patient also experienced heavy bleeding. She experienced spontaneous abortion complete in an emergency room while on vacation on 04-APR-2009, that was 8.2 weeks from her LMP. The patient was seen in the reporter's office on 08-APR-2009 and confirmed spontaneous abortion and by ultrasound. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information is not expected.
VAERS ID: 346965   Vaccination Date: 0000-00-00
Age:    Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-05-20
State: Unknown   Entered: 2009-05-22
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0905USA01916
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a female concerning her daughter, for a pregnancy registry for GARDASIL, who on an unspecified date was vaccinated with the first dose of GARDASIL. The reporter stated that the patient did not know at the time of the vaccination that she was pregnant. The patient had the baby 3 weeks after the vaccination. It was reported the patient sought unspecified medical attention. It was reported that the baby died. The patient was 9 weeks pregnant. Upon internal review, baby died at 9 weeks was determined to be an other important event. No further information is available.
VAERS ID: 347729   Vaccination Date: 2009-02-11
Age: 22.0   Onset Date: 2009-02-11   Days later: 0
Gender: Female   Submitted: 2009-05-27
State: Unknown   Entered: 2009-05-28
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/1/2009)
Diagnostic Lab Data: urine beta-human, 02/??/09, Positive
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0903USA01606
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0843X 0 IM UN
MMR MERCK & CO. INC. 1366X   UN UN
TDAP UNKNOWN MANUFACTURER     UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a licensed practical nurse for GARDASIL and MMR II, Pregnancy Registry products, concerning a female patient with no known drug allergies who on 11-FEB-2009 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X), 0.5 mL, intramuscular administration. Concomitant therapy administered on 11-FEB-2009 included MMR II (lot # 662817/1366X) albumin status rHA, and Tdap (unspecified). It was reported that the patient was pregnant. LMP was in January 2009, EDD was 08-OCT-2009. No adverse effect was reported. The patient sought medical attention at the physician's office. Follow up information was received from a licensed practical nurse. She reported that the patient received the GARDASIL, MMR II and Tdap (manufacturer unknown) early in her pregnancy. The licensed practical nurse stated that this patient had her pregnancy confirmed at the health department (urine hCG test) and after a few weeks, she called to report that she had a miscarriage (specific date not provided). The licensed practical nurse reported she requested that the patient come in for follow up, but she had not seen or heard from her since the phone call. Upon internal review miscarriage was determined to be an other important medical event. No further information is available. Additional information has been requested.
VAERS ID: 349082   Vaccination Date: 2007-12-31
Age: 18.0   Onset Date: 2008-06-01   Days later: 153
Gender: Female   Submitted: 2009-06-12
State: Texas   Entered: 2009-06-15
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown); Depression
Diagnostic Lab Data: Urine beta-human, 05/31/08, negative; Urine beta-human, 06/03/08, positive
Previous Vaccinations:
Other Medications: [Therapy unspecified]
Preexisting Conditions: Attention deficit disorder
CDC 'Split Type': WAES0806USA00890
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0928U 1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a physician for the Pregnancy Registry for GARDASIL regarding an 18 year old female with depression and a history of attention deficit disorder (1988) who on 31-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 657006/0188U; site not reported). On 31-DEC-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 658554/0928U; site not reported). On 31-MAY-2008 (also reported as 4 days ago), the patient took a home pregnancy test which was negative. On 03-JUN-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # reported as "0178U"; site not reported). Concomitant therapy included an unspecified antidepressant. On 03-JUN-2008, the patient took four home pregnancy tests which were all positive. The LMP date was not reported. The patient sought unspecified medical attention in the office. The patient outcome was not reported. No additional information was provided. All telephone attempts to contact the physician have been unsuccessful. Follow up information was received from the licensed practical nurse concerning the 18 year old patient who experienced miscarriage in approximately June 2008 which was about 2-3 weeks after the initial report was called in June 2008. The patient was doing fine. Upon internal review, miscarriage was determined to be an other important medical event. Additional information is not expected.
VAERS ID: 349179   Vaccination Date: 2007-10-07
Age: 18.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-06-15
State: New Jersey   Entered: 2009-06-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Beta-human chorionic, positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: Atrial septal defect repair
CDC 'Split Type': WAES0805USA01495
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0092U 2 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a health professional for the pregnancy registry for GARDASIL concerning a female with a history of atrial septal defect repair at age seven, who on 07-OCT-2007 was vaccinated with GARDASIL (lot # 656371/0181U). On 7-Jan-2008 the patient was vaccinated with her second dose of GARDASIL (lot # 655322/0092U). On 06-May-2008 the patient received her third dose of GARDASIL (lot # 655322/0092U). It was reported that the patient was found to be pregnant later the same day the last vaccination was given. A laboratory report was received in the office of a positive pregnancy test from the hospital the same day the last dose of vaccine was administered. Patient did not report the pregnancy. No problems were reported. Follow-up information has been received from a certified medical assistant who said that the patient was actually not pregnant at the time of the shot. She was not specific about which dose she was talking about. She reported that they found out that the patient lost the pregnancy a few days before her shot and very early in the pregnancy. She was not sure if it was an elective termination or a spontaneous abortion (SAB). Upon internal review, elective termination or a spontaneous abortion (SAB) was determined to be an other important medical event

 

VAERS ID: 341208   Vaccination Date: 2008-12-12
Age: 26.0   Onset Date: 2009-01-01   Days later: 20
Gender: Female   Submitted: 2009-03-05
State: Missouri   Entered: 2009-03-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/18/2009)
Diagnostic Lab Data: Serum beta-human, negative
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0902USA03994
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0571X 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative, Vaginal haemorrhage
Write-up: Information has been received from a licensed practical nurse concerning a 26 year old female with no known medical history and drug allergies, who on 12-DEC-2008 was vaccinated with a first dose of GARDASIL (lot # 660620/0571X) on 12-FEB-2009. The patient received a 0.5 mL second dose of GARDASIL (lot # 661764/0650X), intramuscularly. There was no concomitant medication. It was reported that the patient was pregnant. It was noted that the patient had experienced vaginal spot bleeding that was bright red. It was also reported that the patient miscarried. She was in her first trimester and probably only a couple weeks pregnant. Beta levels were negative and she will not require a dilation and curettage procedure. The patient sought medical attention through a phone call to the practice. Upon internal review, miscarried was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 341209   Vaccination Date: 2008-12-02
Age: 20.0   Onset Date: 2008-12-31   Days later: 29
Gender: Female   Submitted: 2009-03-05
State: New York   Entered: 2009-03-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown); Asthma
Diagnostic Lab Data: urine beta-human, 02/16/09, negative; serum beta-human, 01/26/09, 16; serum beta-human, 02/03/09, <5; beta-human chorionic, 12/02/08, negative
Previous Vaccinations: Vaccine exposure during; Cramp~HPV (Gardasil)~1~20~In Patient
Other Medications: Albuterol
Preexisting Conditions:
CDC 'Split Type': WAES0902USA04266
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0152X 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative, Urine human chorionic gonadotropin negative
Write-up: Information has been received from a physician assistant and a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma and no known drug allergies or reactions who on 02-DEC-2008 (after a negative pregnancy test) was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #0152X). Concomitant therapy included albuterol. It was noted that the patient got pregnant around the end of December 2008. About 6-7 weeks ago, the patient was assumed to undergo a miscarriage. She experienced abdominal pain. On 04-JAN-2009 the patient was seen at a hospital. On 06-JAN-2009 the patient was seen at the emergency room, experiencing a threatening spontaneous abortion, with no evidence of gestation sack and no evidence of embryonic pole. She was given birth control after the miscarriage. It was reported that unspecified blood was drawn and testing was done. On 26-JAN-2009 the patient had a HCG quant level of 16, and on 03-FEB-2009 a quant level of 5. But the patient never got her period. On 16-FEB-2009 physician assistant spoke with the patient's physician's office to confirm her lack of pregnancy and gave her a pregnancy test with negative result. On 16-FEB-2009 the patient received the second 0.5 ml IM dose of GARDASIL (lot #01423X). The patient also had an adverse event after this second dose (WAES # 0903USA00527). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 341318   Vaccination Date: 2008-09-18
Age: 15.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-03-06
State: Arizona   Entered: 2009-03-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: diagnostic laboratory, fetus had spinal bifida
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0903USA00423
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0072X 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Laboratory test abnormal
Write-up: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female who on 18-SEP-2008 was vaccinated IM with the first dose of GARDASIL 0.5 ml (Lot# 660557/0072X). There was no concomitant medication. After receiving the first dose of GARDASIL, the patient became pregnant and experienced a miscarriage. It was noted that the pregnancy was lost at 16-18 weeks gestation. Upon examination the fetus was found to have spinal bifida. The outcome of miscarriage was unknown. It was reported that the patient sought medical attention: seen by the practice. Upon internal review, the patient's miscarriage was considered an other important medical event. Spina Bifida is considered a congenital anomaly. Additional information has been requested.
VAERS ID: 342594   Vaccination Date: 2009-01-20
Age: 16.0   Onset Date: 2009-01-20   Days later: 0
Gender: Female   Submitted: 2009-03-24
State: Unknown   Entered: 2009-03-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/4/2009)
Diagnostic Lab Data: diagnostic laboratory, results pending; urine beta-human, 02/03/09, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0902USA00936
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0650X 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a registered nurse and a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient who on 20-Jan-2009 was vaccinated with the first dose of GARDASIL (lot # 661764/0650X). The patient was pregnant. LMP was 04-JAN-2009, and estimated delivery date was 11-OCT-2009. The patient's mother had history of coagulation disorders, so blood work was taken on the patient with results pending to determine if the patient also had any unknown medical conditions that would affect the pregnancy. On 03-FEB-2009 urine pregnancy test was performed with positive result. The patient sought unspecified medical attention. Follow-up information was received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient with a history of 0 previous pregnancies and 0 of previous live births, who on 10-FEB-2008 (5 weeks from LMP) had a spontaneous abortion. The patient had not received any prenatal testing. The products of conception were not examined. The patient's mother had a history of coagulopathy which was not diagnosed. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 342700   Vaccination Date: 2009-01-26
Age: 23.0   Onset Date: 2009-03-16   Days later: 49
Gender: Female   Submitted: 2009-03-25
State: Washington   Entered: 2009-03-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: ultrasound, 03/16/09, blighted ovum and no gestational sack
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0903USA00408
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blighted ovum, Drug exposure during pregnancy, Ultrasound scan abnormal
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female who was vaccinated with the first or second dose of GARDASIL 0.5ml (Lot# not reported). Couple days later, the patient called the office and informed that she think she was pregnant. The patient had a home pregnancy test, the result was not reported. The outcome of adverse event was unknown. It was reported that the patient sought unspecified medical attention. Follow-up information was received from the registered nurse who reported that the patient on 26-NOV-2008 was vaccinated with the first dose of GARDASIL (Lot# not reported), on 26-JAN-2009 was vaccinated with the second dose of GARDASIL (Lot# not reported) 0.5ml. The registered nurse reported the patient was not pregnant when she received GARDASIL. The patient's LMP Was unknown. On an unspecified date, the patient miscarried. An ultrasound on 16-MAR-2009 showed "blighted ovum and no gestational sack". Upon internal review, the miscarried and blighted ovum were determined to be an other important medical event. Additional information is not expected.
VAERS ID: 342937   Vaccination Date: 2008-09-22
Age: 35.0   Onset Date: 2008-10-14   Days later: 22
Gender: Female   Submitted: 2009-03-24
State: Minnesota   Entered: 2009-03-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Unknown
CDC 'Split Type': 200803144
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR C2767A   IM RA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Initial information was received from a health care professional on 09 October 2008. A 35 year old pregnant female with no reported obstetric history received a right deltoid injection of ADACEL (lot number C2767AA) on 22 September 2008. It was not known whether the patient experienced any adverse events. The patient's date of her last menstrual period was 05 September 2008. The patient's estimated date of confinement was not reported. No further information was provided. Follow-up information was received 15 December 2008 from a health care professional who stated that they had no additional information regarding this patient and provided the contact information for the patient's OB/GYN. Follow-up information was received from another health care professional on 19 March 2009. The patient had not been vaccinated at that facility, and the reporter had no information regarding vaccination. The patient had begun care at the facility on 10 October 2008, and per the reporter the patient's due date was 10 October 2009. No additional information was provided. Follow up information was received from another health care professional on 23 March 2009. The patient had a miscarriage on 14 October 2008. No further information was provided. Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious. Documents held by sender: None.
VAERS ID: 343686   Vaccination Date: 2009-01-14
Age: 18.0   Onset Date: 2009-02-02   Days later: 19
Gender: Female   Submitted: 2009-04-07
State: Texas   Entered: 2009-04-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: none
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: unknown
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL ACAMBIS, INC.     ID  
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in spontaneous abortion.
VAERS ID: 343786   Vaccination Date: 2009-03-04
Age: 17.0   Onset Date: 2009-03-04   Days later: 0
Gender: Female   Submitted: 2009-04-08
State: Illinois   Entered: 2009-04-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 2/13/2009)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0903USA03642
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC. 1741X 1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse, for VARIVAX vaccine (MERCK), a Pregnancy Registry product concerning a 17 year old pregnant female with no medical history or allergies (The pregnancy test was performed on unspecified date, last menstrual period: 14-FEB-2009 and estimated delivery date: 21-NOV-2009) who on 04-MAR-2009 was vaccinated with VARIVAX (MERCK) (previous dose administered on 14-APR-1999). There was no concomitant therapy. The patient sought unspecified medical attention. No adverse effect was reported. Follow up information was received from another registered nurse. It was reported the patient was vaccinated with VARIVAX (MERCK) (lot # 662010/1741X). The patient's last menstrual period was 13-FEB-2009 (previously reported as 14-FEB-2009), so the estimated delivery date was changed to 20-NOV-2009. Follow up information was received from a nurse via phone call. It was reported that she received call from the patient's foster parents, and that they informed her that the patient had had a miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 343848   Vaccination Date: 2009-03-05
Age: 31.0   Onset Date: 2009-03-05   Days later: 0
Gender: Female   Submitted: 2009-04-09
State: Pennsylvania   Entered: 2009-04-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: No concurrent medication
Preexisting Conditions:
CDC 'Split Type': A0774135A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 UN LA
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Underdose
Write-up: This case was reported by a physician (also the father of the subject) and described the occurrence of vaccine underdose in a 31-year-old pregnant female subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On 5 March 2009 the subject received 1st dose of HAVRIX at 1.0 ml (1440 elisa units) in the left arm. During vaccine administration, the needle was not secured on the prefilled syringe and some of the dose leaked out onto the subject's arm. The physician was not sure how much of the dose the subject received. This was considered to be a vaccine underdose and a case of vaccine exposure during pregnancy. No adverse events were reported. It was noted that the subject was due in 8 months from the time of reporting. Follow-up information was received from the reporting physician on 30 March 2009. It was reported that the vaccine spilled out before the total injection could be made. Last menstrual period was unknown. On an unspecified date, the subject had a miscarriage. This case was assessed as medically serious by GSK.
VAERS ID: 343863   Vaccination Date: 2008-03-20
Age: 16.0   Onset Date: 2008-03-20   Days later: 0
Gender: Female   Submitted: 2009-04-09
State: New York   Entered: 2009-04-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/10/2008)
Diagnostic Lab Data: diagnostic laboratory, 03/20?/08, posit -; ultrasound, 03/26/08 - pending; urine beta- human, 03/20?/08 posit - erythrocyte Rh antigen, negat -
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0804USA01379
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test abnormal, Rhesus antibodies negative, Ultrasound scan, Urine human chorionic gonadotropin positive, Wrong drug administered
Write-up: Information has been received from a health professional for GARDASIL, a Pregnancy Registry product, concerning a female who became pregnant during the series of vaccinations. The patient was being seen at a different clinic for the series. The patient received her first dose "a few months ago" (date unspecified). The patient's LMP was 10-Jan-2008. The patient returned to the clinic two weeks ago for a pregnancy test and was inadvertently administered a second dose of GARDASIL. On approximately 20-MAR-2008, the patient was vaccinated with her second dose of GARDASIL (lot number unspecified). Concomitant therapy included PEDIARIX and a third vaccine (name not known at the time of report). The patient has had a urine pregnancy test that was positive and blood work completed. She also had an ultrasound performed on 26-Mar-2008 and the results are pending. The patient has not reported any difficulties thus far. Follow up information was received from a Licensed Practical Nurse who reported that the patient had not returned to her clinic, the patient received her prenatal care at another clinic. The L.P.N had gotten in contact with the patient's mother. It was reported that the pregnancy ended in spontaneous abortion at five months (approximately on 10-JUN-2008). The patient was RH negative and had not received any Rhogam in preparation for the pregnancy. The patient's doctor stated that this was the reason for the miscarriage and that it was not related to the vaccination with GARDASIL. The L.P.N indicated that the patient is pregnant again and "everything was going well with the pregnancy". No further information is available

 

VAERS ID: 336580   Vaccination Date: 0000-00-00
Age: 25.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-01-05
State: Florida   Entered: 2009-01-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown) Drug hypersensitivity
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0812USA05190
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a consumer, for the Pregnancy Registry for GARDASIL vaccine, concerning his 25 year old wife general anesthesia allergy who was vaccinated 3 doses of GARDASIL vaccine (Lot # not reported) prior to becoming pregnant. Concomitant therapy included heart medication. Consumer's wife is the patient in this case. Consumer reported that his wife had completed the GARDASIL vaccine series approximately six months to becoming pregnant with their first child. Consumer reported that they learned at 17 weeks gestation that his wife had lost their baby around 12 weeks of gestation. Laboratory test was performed previous to pregnancy and during pregnancy. Consumer reported that his wife will call back with more specific dates and information. Upon internal review, abortion spontaneous was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 337616   Vaccination Date: 2008-11-04
Age: 18.0   Onset Date: 2008-12-15   Days later: 41
Gender: Female   Submitted: 2009-01-16
State: Arizona   Entered: 2009-01-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: None
Diagnostic Lab Data: N/A
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type': AZ0901
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0279X 4 IM RA
Administered by: Public     Purchased by: Public
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Had 1st HPV on November 4th, 2008. she stated she didn't know she was pregnant. Had a miscarrieage in December. (Came in today becase she is due her 2nd dose.)
VAERS ID: 337815   Vaccination Date: 2008-02-15
Age: 21.0   Onset Date: 2008-03-03   Days later: 17
Gender: Female   Submitted: 2009-01-20
State: Florida   Entered: 2009-01-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/3/2008)
Diagnostic Lab Data: Beta-human chorionic, 04/15/08, positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0804USA03264
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1740U 1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a nurse practitioner and a certified nurse midwife, for the pregnancy registry for GARDASIL, concerning a 21 year old female with no medical history, no known drug allergies and with no history of previous pregnancies who on 15-FEB-2008 was vaccinated IM with the first 0.5 ml IM dose of GARDASIL (lot # 659962/1740U). The patient received the second 0.5 ml IM dose on 15-Apr-2008 (lot# 659962/1740U). There was no concomitant medication. On 15-APR-2008 the patient had a positive pregnancy test result. The patient's LMP was 03-Mar-2008 and an estimated delivery date is 08-Dec-2008. No other symptoms were noted. Patient sought medical attention via an office visit. Follow up information has been received from a certified nurse midwife, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female patient. In May 2008, the patient was seen due to a miscarriage. It is not known if the patient had received any prenatal care prior to the miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. No further information is available.
VAERS ID: 338867   Vaccination Date: 2008-10-21
Age: 15.0   Onset Date: 2008-11-08   Days later: 18
Gender: Female   Submitted: 2009-02-02
State: Connecticut   Entered: 2009-02-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 11/8/2008); Penicillin allergy; Psoriasis
Diagnostic Lab Data: beta-human chorionic, positive
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0901USA01798
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER     UN UN
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a nurse and the patient's mother for the pregnancy registry for GARDASIL, concerning a 15 year old female with Amoxicillin allergy and psoriasis who on 21-OCT-2008 was vaccinated with the first dose GARDASIL (Lot not provided). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 23-DEC-2008 the patient received the second dose of GARDASIL (Lot not provided). Subsequently the patient discovered that she was pregnant via pregnancy test (LMP: 08-NOV-2008, EDD: 15-AUG-2009). As of 15-JAN-2009 the patient was fine. Follow up information has been received on 29-JAN-2009 from the patient's mother concerning her 15 year old daughter who on 25-JAN-2009 had a miscarriage. Upon internal review, miscarriage was considered to be an Other Important Medical Event. Additional information has been requested.
VAERS ID: 340377   Vaccination Date: 2008-10-21
Age: 14.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-02-06
State: Arizona   Entered: 2009-02-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: BC (OCP)
Preexisting Conditions:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0548X 0 IM UN
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Pt learned she was pregnant 2 months after receiving GARDASIL vaccine. Pt miscarried at 2 1/2- 3 mos pregnant.
VAERS ID: 340969   Vaccination Date: 2007-12-29
Age: 26.0   Onset Date: 2008-01-24   Days later: 26
Gender: Female   Submitted: 2009-03-02
State: Oregon   Entered: 2009-03-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0902USA04384
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first and second 0.5mL doses of GARDASIL on 29-JUN-2007 and 29-SEP-2007. The physician reported that they believed the patient was pregnant on 10-DEC-2007. On 29-DEC-2007, the patient was vaccinated with the dose of GARDASIL. On 24-JAN-2008 the patient experienced miscarriage. Lab test performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review miscarriage has been considered an other important medical event. Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage (WAES #0902USA04455). Additional information has been requested.
VAERS ID: 340970   Vaccination Date: 2007-12-29
Age: 26.0   Onset Date: 2008-06-01   Days later: 155
Gender: Female   Submitted: 2009-03-02
State: Oregon   Entered: 2009-03-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0902USA04455
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first, second and third 0.5mL dose of GARDASIL on 29-JUN-2007, 29-SEP-2007 and 29-DEC-2007. On 24-JAN-2008, the patient had a miscarriage (MSD WAES # 0902USA04384). Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage. Lab tests performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
reatening spontaneous abortion, with no evidence of gestation sack and no evidence of embryonic pole. She was given birth control after the miscarriage. It was reported that unspecified blood was drawn and testing was done. On 26-JAN-2009 the patient had a HCG quant level of 16, and on 03-FEB-2009 a quant level of 5. But the patient never got her period. On 16-FEB-2009 physician assistant spoke with the patient's physician's office to confirm her lack of pregnancy and gave her a pregnancy test with negative result. On 16-FEB-2009 the patient received the second 0.5 ml IM dose of GARDASIL (lot #01423X). The patient also had an adverse event after this second dose (WAES # 0903USA00527). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 341318   Vaccination Date: 2008-09-18
Age: 15.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-03-06
State: Arizona   Entered: 2009-03-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: diagnostic laboratory, fetus had spinal bifida
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0903USA00423
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0072X 0 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Laboratory test abnormal
Write-up: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female who on 18-SEP-2008 was vaccinated IM with the first dose of GARDASIL 0.5 ml (Lot# 660557/0072X). There was no concomitant medication. After receiving the first dose of GARDASIL, the patient became pregnant and experienced a miscarriage. It was noted that the pregnancy was lost at 16-18 weeks gestation. Upon examination the fetus was found to have spinal bifida. The outcome of miscarriage was unknown. It was reported that the patient sought medical attention: seen by the practice. Upon internal review, the patient's miscarriage was considered an other important medical event. Spina Bifida is considered a congenital anomaly. Additional information has been requested.
VAERS ID: 342594   Vaccination Date: 2009-01-20
Age: 16.0   Onset Date: 2009-01-20   Days later: 0
Gender: Female   Submitted: 2009-03-24
State: Unknown   Entered: 2009-03-25
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/4/2009)
Diagnostic Lab Data: diagnostic laboratory, results pending; urine beta-human, 02/03/09, positive
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0902USA00936
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0650X 0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Urine human chorionic gonadotropin positive
Write-up: Information has been received from a registered nurse and a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient who on 20-Jan-2009 was vaccinated with the first dose of GARDASIL (lot # 661764/0650X). The patient was pregnant. LMP was 04-JAN-2009, and estimated delivery date was 11-OCT-2009. The patient's mother had history of coagulation disorders, so blood work was taken on the patient with results pending to determine if the patient also had any unknown medical conditions that would affect the pregnancy. On 03-FEB-2009 urine pregnancy test was performed with positive result. The patient sought unspecified medical attention. Follow-up information was received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient with a history of 0 previous pregnancies and 0 of previous live births, who on 10-FEB-2008 (5 weeks from LMP) had a spontaneous abortion. The patient had not received any prenatal testing. The products of conception were not examined. The patient's mother had a history of coagulopathy which was not diagnosed. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 342700   Vaccination Date: 2009-01-26
Age: 23.0   Onset Date: 2009-03-16   Days later: 49
Gender: Female   Submitted: 2009-03-25
State: Washington   Entered: 2009-03-26
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: ultrasound, 03/16/09, blighted ovum and no gestational sack
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0903USA00408
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blighted ovum, Drug exposure during pregnancy, Ultrasound scan abnormal
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female who was vaccinated with the first or second dose of GARDASIL 0.5ml (Lot# not reported). Couple days later, the patient called the office and informed that she think she was pregnant. The patient had a home pregnancy test, the result was not reported. The outcome of adverse event was unknown. It was reported that the patient sought unspecified medical attention. Follow-up information was received from the registered nurse who reported that the patient on 26-NOV-2008 was vaccinated with the first dose of GARDASIL (Lot# not reported), on 26-JAN-2009 was vaccinated with the second dose of GARDASIL (Lot# not reported) 0.5ml. The registered nurse reported the patient was not pregnant when she received GARDASIL. The patient's LMP Was unknown. On an unspecified date, the patient miscarried. An ultrasound on 16-MAR-2009 showed "blighted ovum and no gestational sack". Upon internal review, the miscarried and blighted ovum were determined to be an other important medical event. Additional information is not expected.
VAERS ID: 342937   Vaccination Date: 2008-09-22
Age: 35.0   Onset Date: 2008-10-14   Days later: 22
Gender: Female   Submitted: 2009-03-24
State: Minnesota   Entered: 2009-03-30
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications:
Preexisting Conditions: Unknown
CDC 'Split Type': 200803144
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP SANOFI PASTEUR C2767A   IM RA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Initial information was received from a health care professional on 09 October 2008. A 35 year old pregnant female with no reported obstetric history received a right deltoid injection of ADACEL (lot number C2767AA) on 22 September 2008. It was not known whether the patient experienced any adverse events. The patient's date of her last menstrual period was 05 September 2008. The patient's estimated date of confinement was not reported. No further information was provided. Follow-up information was received 15 December 2008 from a health care professional who stated that they had no additional information regarding this patient and provided the contact information for the patient's OB/GYN. Follow-up information was received from another health care professional on 19 March 2009. The patient had not been vaccinated at that facility, and the reporter had no information regarding vaccination. The patient had begun care at the facility on 10 October 2008, and per the reporter the patient's due date was 10 October 2009. No additional information was provided. Follow up information was received from another health care professional on 23 March 2009. The patient had a miscarriage on 14 October 2008. No further information was provided. Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious. Documents held by sender: None.
VAERS ID: 343686   Vaccination Date: 2009-01-14
Age: 18.0   Onset Date: 2009-02-02   Days later: 19
Gender: Female   Submitted: 2009-04-07
State: Texas   Entered: 2009-04-07
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: none
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications:
Preexisting Conditions: unknown
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL ACAMBIS, INC.     ID  
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in spontaneous abortion.
VAERS ID: 343786   Vaccination Date: 2009-03-04
Age: 17.0   Onset Date: 2009-03-04   Days later: 0
Gender: Female   Submitted: 2009-04-08
State: Illinois   Entered: 2009-04-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 2/13/2009)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0903USA03642
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL MERCK & CO. INC. 1741X 1 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a registered nurse, for VARIVAX vaccine (MERCK), a Pregnancy Registry product concerning a 17 year old pregnant female with no medical history or allergies (The pregnancy test was performed on unspecified date, last menstrual period: 14-FEB-2009 and estimated delivery date: 21-NOV-2009) who on 04-MAR-2009 was vaccinated with VARIVAX (MERCK) (previous dose administered on 14-APR-1999). There was no concomitant therapy. The patient sought unspecified medical attention. No adverse effect was reported. Follow up information was received from another registered nurse. It was reported the patient was vaccinated with VARIVAX (MERCK) (lot # 662010/1741X). The patient's last menstrual period was 13-FEB-2009 (previously reported as 14-FEB-2009), so the estimated delivery date was changed to 20-NOV-2009. Follow up information was received from a nurse via phone call. It was reported that she received call from the patient's foster parents, and that they informed her that the patient had had a miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 343848   Vaccination Date: 2009-03-05
Age: 31.0   Onset Date: 2009-03-05   Days later: 0
Gender: Female   Submitted: 2009-04-09
State: Pennsylvania   Entered: 2009-04-09
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Unknown
Diagnostic Lab Data: UNK
Previous Vaccinations:
Other Medications: No concurrent medication
Preexisting Conditions:
CDC 'Split Type': A0774135A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA GLAXOSMITHKLINE BIOLOGICALS   0 UN LA
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Underdose
Write-up: This case was reported by a physician (also the father of the subject) and described the occurrence of vaccine underdose in a 31-year-old pregnant female subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On 5 March 2009 the subject received 1st dose of HAVRIX at 1.0 ml (1440 elisa units) in the left arm. During vaccine administration, the needle was not secured on the prefilled syringe and some of the dose leaked out onto the subject's arm. The physician was not sure how much of the dose the subject received. This was considered to be a vaccine underdose and a case of vaccine exposure during pregnancy. No adverse events were reported. It was noted that the subject was due in 8 months from the time of reporting. Follow-up information was received from the reporting physician on 30 March 2009. It was reported that the vaccine spilled out before the total injection could be made. Last menstrual period was unknown. On an unspecified date, the subject had a miscarriage. This case was assessed as medically serious by GSK.
VAERS ID: 343863   Vaccination Date: 2008-03-20
Age: 16.0   Onset Date: 2008-03-20   Days later: 0
Gender: Female   Submitted: 2009-04-09
State: New York   Entered: 2009-04-10
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 1/10/2008)
Diagnostic Lab Data: diagnostic laboratory, 03/20?/08, posit -; ultrasound, 03/26/08 - pending; urine beta- human, 03/20?/08 posit - erythrocyte Rh antigen, negat -
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0804USA01379
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test abnormal, Rhesus antibodies negative, Ultrasound scan, Urine human chorionic gonadotropin positive, Wrong drug administered
Write-up: Information has been received from a health professional for GARDASIL, a Pregnancy Registry product, concerning a female who became pregnant during the series of vaccinations. The patient was being seen at a different clinic for the series. The patient received her first dose "a few months ago" (date unspecified). The patient's LMP was 10-Jan-2008. The patient returned to the clinic two weeks ago for a pregnancy test and was inadvertently administered a second dose of GARDASIL. On approximately 20-MAR-2008, the patient was vaccinated with her second dose of GARDASIL (lot number unspecified). Concomitant therapy included PEDIARIX and a third vaccine (name not known at the time of report). The patient has had a urine pregnancy test that was positive and blood work completed. She also had an ultrasound performed on 26-Mar-2008 and the results are pending. The patient has not reported any difficulties thus far. Follow up information was received from a Licensed Practical Nurse who reported that the patient had not returned to her clinic, the patient received her prenatal care at another clinic. The L.P.N had gotten in contact with the patient's mother. It was reported that the pregnancy ended in spontaneous abortion at five months (approximately on 10-JUN-2008). The patient was RH negative and had not received any Rhogam in preparation for the pregnancy. The patient's doctor stated that this was the reason for the miscarriage and that it was not related to the vaccination with GARDASIL. The L.P.N indicated that the patient is pregnant again and "everything was going well with the pregnancy". No further information is available

 

VAERS ID: 336580   Vaccination Date: 0000-00-00
Age: 25.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-01-05
State: Florida   Entered: 2009-01-06
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown) Drug hypersensitivity
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0812USA05190
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Information has been received from a consumer, for the Pregnancy Registry for GARDASIL vaccine, concerning his 25 year old wife general anesthesia allergy who was vaccinated 3 doses of GARDASIL vaccine (Lot # not reported) prior to becoming pregnant. Concomitant therapy included heart medication. Consumer's wife is the patient in this case. Consumer reported that his wife had completed the GARDASIL vaccine series approximately six months to becoming pregnant with their first child. Consumer reported that they learned at 17 weeks gestation that his wife had lost their baby around 12 weeks of gestation. Laboratory test was performed previous to pregnancy and during pregnancy. Consumer reported that his wife will call back with more specific dates and information. Upon internal review, abortion spontaneous was determined to be an other important medical event. Additional information has been requested.
VAERS ID: 337616   Vaccination Date: 2008-11-04
Age: 18.0   Onset Date: 2008-12-15   Days later: 41
Gender: Female   Submitted: 2009-01-16
State: Arizona   Entered: 2009-01-16
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: None
Diagnostic Lab Data: N/A
Previous Vaccinations:
Other Medications: None
Preexisting Conditions: None
CDC 'Split Type': AZ0901
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0279X 4 IM RA
Administered by: Public     Purchased by: Public
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Had 1st HPV on November 4th, 2008. she stated she didn't know she was pregnant. Had a miscarrieage in December. (Came in today becase she is due her 2nd dose.)
VAERS ID: 337815   Vaccination Date: 2008-02-15
Age: 21.0   Onset Date: 2008-03-03   Days later: 17
Gender: Female   Submitted: 2009-01-20
State: Florida   Entered: 2009-01-21
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 3/3/2008)
Diagnostic Lab Data: Beta-human chorionic, 04/15/08, positive
Previous Vaccinations:
Other Medications: None
Preexisting Conditions:
CDC 'Split Type': WAES0804USA03264
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 1740U 1 IM UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a nurse practitioner and a certified nurse midwife, for the pregnancy registry for GARDASIL, concerning a 21 year old female with no medical history, no known drug allergies and with no history of previous pregnancies who on 15-FEB-2008 was vaccinated IM with the first 0.5 ml IM dose of GARDASIL (lot # 659962/1740U). The patient received the second 0.5 ml IM dose on 15-Apr-2008 (lot# 659962/1740U). There was no concomitant medication. On 15-APR-2008 the patient had a positive pregnancy test result. The patient's LMP was 03-Mar-2008 and an estimated delivery date is 08-Dec-2008. No other symptoms were noted. Patient sought medical attention via an office visit. Follow up information has been received from a certified nurse midwife, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female patient. In May 2008, the patient was seen due to a miscarriage. It is not known if the patient had received any prenatal care prior to the miscarriage. Upon internal review, miscarriage was determined to be an other important medical event. No further information is available.
VAERS ID: 338867   Vaccination Date: 2008-10-21
Age: 15.0   Onset Date: 2008-11-08   Days later: 18
Gender: Female   Submitted: 2009-02-02
State: Connecticut   Entered: 2009-02-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = 11/8/2008); Penicillin allergy; Psoriasis
Diagnostic Lab Data: beta-human chorionic, positive
Previous Vaccinations:
Other Medications:
Preexisting Conditions:
CDC 'Split Type': WAES0901USA01798
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA UNKNOWN MANUFACTURER     UN UN
HPV4 MERCK & CO. INC.   0 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Write-up: Information has been received from a nurse and the patient's mother for the pregnancy registry for GARDASIL, concerning a 15 year old female with Amoxicillin allergy and psoriasis who on 21-OCT-2008 was vaccinated with the first dose GARDASIL (Lot not provided). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 23-DEC-2008 the patient received the second dose of GARDASIL (Lot not provided). Subsequently the patient discovered that she was pregnant via pregnancy test (LMP: 08-NOV-2008, EDD: 15-AUG-2009). As of 15-JAN-2009 the patient was fine. Follow up information has been received on 29-JAN-2009 from the patient's mother concerning her 15 year old daughter who on 25-JAN-2009 had a miscarriage. Upon internal review, miscarriage was considered to be an Other Important Medical Event. Additional information has been requested.
VAERS ID: 340377   Vaccination Date: 2008-10-21
Age: 14.0   Onset Date: 0000-00-00   Days later:
Gender: Female   Submitted: 2009-02-06
State: Arizona   Entered: 2009-02-23
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: BC (OCP)
Preexisting Conditions:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC. 0548X 0 IM UN
Administered by: Military     Purchased by: Military
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Write-up: Pt learned she was pregnant 2 months after receiving GARDASIL vaccine. Pt miscarried at 2 1/2- 3 mos pregnant.
VAERS ID: 340969   Vaccination Date: 2007-12-29
Age: 26.0   Onset Date: 2008-01-24   Days later: 26
Gender: Female   Submitted: 2009-03-02
State: Oregon   Entered: 2009-03-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Pregnancy NOS (LMP = Unknown)
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions:
CDC 'Split Type': WAES0902USA04384
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first and second 0.5mL doses of GARDASIL on 29-JUN-2007 and 29-SEP-2007. The physician reported that they believed the patient was pregnant on 10-DEC-2007. On 29-DEC-2007, the patient was vaccinated with the dose of GARDASIL. On 24-JAN-2008 the patient experienced miscarriage. Lab test performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review miscarriage has been considered an other important medical event. Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage (WAES #0902USA04455). Additional information has been requested.
VAERS ID: 340970   Vaccination Date: 2007-12-29
Age: 26.0   Onset Date: 2008-06-01   Days later: 155
Gender: Female   Submitted: 2009-03-02
State: Oregon   Entered: 2009-03-03
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness:
Diagnostic Lab Data: Unknown
Previous Vaccinations:
Other Medications: Unknown
Preexisting Conditions: Miscarriage
CDC 'Split Type': WAES0902USA04455
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4 MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first, second and third 0.5mL dose of GARDASIL on 29-JUN-2007, 29-SEP-2007 and 29-DEC-2007. On 24-JAN-2008, the patient had a miscarriage (MSD WAES # 0902USA04384). Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage. Lab tests performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.