VAERS ID: |
128185 |
Vaccination Date: |
1998-10-05 |
Age: |
37.1 |
Onset Date: |
1998-12-01 Days later: 57 |
Gender: |
Female |
Submitted: |
1999-09-10 |
State: |
New York |
Entered: |
1999-09-13 |
|
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: |
Preexisting Conditions: mitral valve prolapse (1978);
urinary tract infect |
CDC 'Split Type': 1998024794 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
UNKNOWN MANUFACTURER |
|
0 |
|
|
HEPA |
SMITHKLINE BEECHAM |
|
1 |
|
|
|
Administered by: Private Purchased by:
Other |
Symptoms: Abortion |
Write-up: p/vax pt could possible be preg, starting
10/4/98; pt devel flu; MD stated that pt had a spontaneous
abortion |
|
|
VAERS ID: |
179730 |
Vaccination Date: |
2001-11-06 |
Age: |
48.0 |
Onset Date: |
2001-11-11 Days later: 5 |
Gender: |
Female |
Submitted: |
2001-12-23 |
State: |
California |
Entered: |
2002-01-07 |
|
Life Threatening Illness? No |
Died? No |
Disability? No |
Recovered? Yes |
ER or Doctor Visit? Yes |
Hospitalized? No |
Current Illness: URI |
Diagnostic Lab Data: Sonogram |
Previous Vaccinations: |
Other Medications: Progestrone,Estrpgen, Folic Acid,
ASA |
Preexisting Conditions: NONE |
CDC 'Split Type': |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
EVANS VACCINES |
E73100LA |
0 |
|
LA |
|
Administered by: Public Purchased by:
|
Symptoms: Abortion |
Write-up: 11/11/2001-Seven weeks into her pregnancy,
the patient had a spontaneous abortion. |
|
|
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: |
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: |
217805 |
Vaccination Date: |
2001-11-20 |
Age: |
19.0 |
Onset Date: |
2001-11-22 Days later: 2 |
Gender: |
Female |
Submitted: |
2004-03-12 |
State: |
Alaska |
Entered: |
2004-03-12 |
|
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: NONE |
Diagnostic Lab Data: WBC elevated, lab test abn |
Previous Vaccinations: |
Other Medications: NONE |
Preexisting Conditions: Group B streptococcus UTI; |
CDC 'Split Type': AK200424 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
UNKNOWN MANUFACTURER |
Unknown |
0 |
|
RA |
|
Administered by: Unknown Purchased by:
Unknown |
Symptoms: Abortion, Back pain, Headache, Laboratory
test abnormal, Nausea, Vomiting, White blood cell disorder |
Write-up: Headache, lower back pain, nausea,
vomiting, loss of unborn child. Lasted for two weeks; resulted
in hospitalization. Nurse follow up on 05/18/04: spontaneous
rupture of membranes. |
|
|
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: |
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: |
276055 |
Vaccination Date: |
2006-10-18 |
Age: |
|
Onset Date: |
2006-10-27 Days later: 9 |
Gender: |
|
Submitted: |
0000-00-00 |
State: |
Unknown |
Entered: |
2007-04-11 |
|
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: UNISOM, NITROFURANTOIN, LEVOXYL,
PRE-NATAL VITAMINS WITH DOXALYMINE |
Preexisting Conditions: The vaccinee has a history of
hypothyroid. |
CDC 'Split Type': CVOX200600266 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
CHIRON CORPORATION |
70279 |
|
IM |
LA |
|
Administered by: Unknown Purchased by:
Unknown |
Symptoms: Abortion induced, Drug exposure during
pregnancy, Injection site erythema, Injection site pruritus,
Injection site urticaria, Injection site warmth, Spina bifida |
Write-up: A report was received from a healthcare
professional on 20/Oct/2006 concerning a 34 year old pregnant
vaccinee. No details of the vaccinees past medical history or
details of any concomitant medications were provided. On
13/Oct/2006 the vaccinee was administered Fluvirin 0.5mls by
intramuscular injection. By the following day (19/Oct/2006) she
had developed a hugh wheal, about 3 inches in diameter, at the
injection site, which was also hot, red and itchy. Further
information is requested. A follow-up report was received from a
healthcare professional concerning a pregnant 34-year-old female
vaccinee. The vaccinee has a history of Hypothyroid since 2003
which is on going. The vaccinee's concomitant medications
include Levoxyl, 0.05 mg once a day, orally for Hypothyroid,
since 2003 and is on going, Pre-natal vitamins with Doxalymine,
1 tablet once a day, orally for pregnancy since Jun/2006 and is
on going, Unisom, 1 tablet once a day, orally for nausea from
Sep/2006 to Oct/2006 and Nitrofurantoin, as required, orally for
bladder infections in 2004. The vaccinee also received an
influenza vaccinee (brand unspecified) in Oct/2005. On
18/Oct/2006, the vaccinee received 0.5ml of Fluvirin, once,
intramuscularly into her upper left arm. On 19/Oct/2006, the
vaccinee experienced a red wheal at the injection site, which
resolved on 23/Oct/2006. On 27/Oct/2006, the vaccine had an
elective termination of pregnancy, due to Spina Bifida. The
infant was a 12 oz male. The reporter dose not considered the
red wheal at the injection site to be serious and is unknown if
it is related to Fluvirin. No further information is expected. |
|
|
VAERS ID: |
284078 |
Vaccination Date: |
2006-09-25 |
Age: |
33.0 |
Onset Date: |
0000-00-00 Days later: |
Gender: |
Female |
Submitted: |
2007-07-05 |
State: |
Texas |
Entered: |
2007-07-09 |
|
Life Threatening Illness? No |
Died? No |
Disability? No |
Recovered? No |
ER or Doctor Visit? Yes |
Hospitalized? No |
Current Illness: |
Diagnostic Lab Data: prenatal testing: serologies
done on 25-Oct-2006 - normal: ultrasound 03-Nov-2006 - showed no
fetal cardiac activity. |
Previous Vaccinations: |
Other Medications: PRENATAL |
Preexisting Conditions: Past obstetric history
included one previous pregnancy and subsequent full term
delivery with a normal outcome. Follow-up information received
on 11 May 2007. She did not have any illness at the time of the
vaccination. Her previous pregnancy occurred in 2004. |
CDC 'Split Type': 200602672 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
SANOFI PASTEUR |
U2201AA |
|
IM |
|
TDAP |
SANOFI PASTEUR |
C2559AA |
0 |
IM |
LA |
|
Administered by: Private Purchased by:
Private |
Symptoms: Abortion missed, Drug exposure during
pregnancy, Foetal heart rate abnormal, Serology normal,
Ultrasound scan abnormal |
Write-up: SERIOUSNESS CRITERIA: OTHER - MEDICALLY
SIGNIFICANT. Initial report received from a physician on 12
October 2006. A 33 year old female patient received on 25
September 2006, intra-muscular, 0.5 ml booster of Adacel (lot
number C2559AA, expiry date 12 August 2008), while she was 1
week pregnant (LMP was 10 June 2007). The patient did not
receive any concomitant vaccines. The patient's past obstetric
history included one previous pregnancy and subsequent full term
delivery with a normal outcome. At the time of the report (12
October 2006), the patient did not have prenatal testing yet. No
information about prior exposures to Adacel was provided. The
patient did not experience any adverse reactions following
receipt of Adacel on 25 September 2006. Follow-up information
received on 11 May 2007. The patient received Adacel in the left
deltoid and she did not have any illness at that time. The
patient's past obstetric history included one previous pregnancy
and subsequent full term delivery with a normal outcome in 2004.
The patient's last menstrual period was 04 September 2006 and
her expected date of delivery is 11 June 2007. The patient was
last seen on 06 October 2006 for confirmation of pregnancy and
was lost to follow-up by the reporting physician. She was
referred to an OB/GYN for prenatal care. The reporting physician
was not aware of the current pregnancy outcome. Follow-up
information received on 02 July 2007 from a health care
professional, Date of last menstrual periods was 11 September
2006. The estimated date of delivery was 11 June 2007. Past
obstetric history included: 1 live birth, previous pregnancy
with no pre-term / congenital anomalies. The patient received
one intramuscular dose of Fluzone (lot# U2201AA) on 30 October
2006. Prenatal testing included serologies on 25 October 2006,
which was normal and ultrasound on 03 November 2006, which
showed no fetal cardiac activity. Outcome of the pregnancy was
missed abortion on the first trimester with Dilation and
curettage (D&C). |
|
VAERS ID: |
40511 |
Vaccination Date: |
1991-11-13 |
Age: |
34.0 |
Onset Date: |
1992-03-18 Days later: 126 |
Gender: |
Female |
Submitted: |
0000-00-00 |
State: |
|
Entered: |
1992-03-23 |
|
Life Threatening Illness? No |
Died? No |
Disability? No |
Recovered? Yes |
ER or Doctor Visit? No |
Hospitalized? No |
Current Illness: |
Diagnostic Lab Data: 26NOV91 Ultrasound-confirmed 5
1/2 wk fetus; JAN91 Ultrasound-grossly abn fetus; |
Previous Vaccinations: |
Other Medications: |
Preexisting Conditions: hx of irregular menstrual
cycles; |
CDC 'Split Type': CO4137 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
CONNAUGHT LABORATORIES |
|
|
|
|
|
Administered by: Unknown Purchased by:
Unknown |
Symptoms: Abortion, Foetal disorder |
Write-up: Pt underwent termination of pregnancy; LMP
30SEP91, sl PV bleeding on 10NOV91; Recvd vax on 13NOV91;
ultrasound confirmed 5 1/2 wk fetus on 26NOV91; JAN92 ultrasound
showed "grossly abn fetus; preg terminated 4FEB92; |
|
|
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: |
225155 |
Vaccination Date: |
2003-10-08 |
Age: |
36.0 |
Onset Date: |
2003-12-04 Days later: 57 |
Gender: |
Female |
Submitted: |
2004-08-30 |
State: |
|
Entered: |
2004-08-09 |
|
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: |
Preexisting Conditions: Pregnant, LMP date: 9/20/03;
No relevant history reported. |
CDC 'Split Type': E200303410 |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
UNKNOWN MANUFACTURER |
|
|
|
|
|
Administered by: Unknown Purchased by:
Unknown |
Symptoms: Abortion, Unintended pregnancy |
Write-up: Case upgraded to serious on 7/30/04 for
other seriousness criteria: Spontaneous abortion. Case reported
by a health care professional. Case involves an inadvertent
administration of vaccine during pregnancy. It was reported that
a 36 year old female received influenza vaccine (batch not
reported) at her occupational health department. The patient
then discovered that she was pregnant and so contacted the
reporter for advise. Further information requested. Case to
remain open. Follow up 7/30/04: LMP date 9/20/03. Date of
vaccination 8/10/03 but manufacturer not confirmed as not given
in reporting surgery. Gestational age therefore reported as 3
weeks, however likely to be 1 week if conception assumed to be 2
weeks post LMP date. Expected delivery date was 6/29/04. However
patient experienced a spontaneous abortion commencing on
4/12/03. Case will be followed up. (OMIC) Follow up 25/8/04 ASPP
received from HA. |
|
|
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: |
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: |
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: |
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: |
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: |
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: |
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: |
332613 |
Vaccination Date: |
2007-01-31 |
Age: |
39.0 |
Onset Date: |
0000-00-00 Days later: |
Gender: |
Female |
Submitted: |
2008-11-17 |
State: |
|
Entered: |
2008-11-17 |
|
Life Threatening Illness? No |
Died? No |
Disability? No |
Recovered? No |
ER or Doctor Visit? No |
Hospitalized? No |
Current Illness: Unknown |
Diagnostic Lab Data: Diagnostic ultrasound, hydrops
feta |
Previous Vaccinations: |
Other Medications: |
Preexisting Conditions: |
CDC 'Split Type': B0545228A |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
FLU |
UNKNOWN MANUFACTURER |
|
|
UN |
LA |
|
Administered by: Other Purchased by: Other |
Symptoms: Abortion induced, Drug exposure during
pregnancy, Hydrops foetalis, Ultrasound scan abnormal |
Write-up: This case was reported by a regulatory
authority (foreign Medicines Control Agency #
NO-NOMAADVRE-FHI-2008-6654) and described the occurrence of
induced abortion in a 39-year-old female subject who was
vaccinated with Influenza vaccine unspecified, manufacturer
unspecified. On 31 January 2007, the subject received
unspecified dose of Influenza vaccine unspecified (parenteral,
unknown injection site, unknown lot number). The vaccine was
administered 13 days after her last menstrual period. At
unspecified time after vaccination with Influenza vaccine
unspecified, the subject experienced hydrops fetalis diagnosed
by ultrasound at 12 weeks pregnancy. The patient experienced
induced abortion. The regulatory authority reported that the
event was a congenital anomaly. The regulatory authority
reported that the events were possibly related to vaccination
with Influenza vaccine unspecified. No additional information
has been requested; the case has been closed. |
|
|
VAERS ID: |
336502 |
Vaccination Date: |
2008-09-24 |
Age: |
21.0 |
Onset Date: |
2008-11-11 Days later: 48 |
Gender: |
Female |
Submitted: |
2009-01-05 |
State: |
|
Entered: |
2009-01-05 |
|
Life Threatening Illness? No |
Died? No |
Disability? No |
Recovered? No |
ER or Doctor Visit? Yes |
Hospitalized? No |
Current Illness: none |
Diagnostic Lab Data: 10/10/2008, negative urine HCG;
11/12/2008, positive urine HCG |
Previous Vaccinations: |
Other Medications: none |
Preexisting Conditions: none |
CDC 'Split Type': |
|
Vaccination |
Manufacturer |
Lot |
Dose |
Route |
Site |
ANTH |
UNKNOWN MANUFACTURER |
FAV173 |
|
SC |
UN |
FLU |
UNKNOWN MANUFACTURER |
500550P |
|
IN |
|
|
Administered by: Military Purchased by:
Military |
Symptoms: Abdominal pain, Abortion threatened,
Amenorrhoea, Anaemia, Chlamydia identification test negative,
Drug exposure during pregnancy, Genital haemorrhage, Haematocrit
normal, Haemoglobin increased, Red blood cell count decreased,
Ultrasound scan normal, Urine human chorionic gonadotropin
positive |
Write-up: Received AVA #2 on 10/28/08. Reported to
clinic 2 weeks later (11/11/08) for AVA #3 and showed positive
HCG test. Third AVA held. Symptoms: Amenorrhea. First OB visit
was 12/11/08 and placed on Iron supplements. Iron panel and 2nd
trimester US ordered. PT seen in ER in other country X 2 with
vaginal spotting and abd cramping. Diagnosed w/threatened AB and
anemia (12/19 and 12/27). Email from pt on 12/27/08 4:38 AM
stated preg and baby were well, then in ER that evening 1903
with 5 minutes of vag spotting. No active bleeding noted but
test results showed decreasing Quant hcg: 12/19 = 56,337 and
12/27 = 39,133.68 and anemic: RBC 3.56, hgb 33.5 and hct 35.8.
Current GC/KOH/wet prep and chlymadia all negative. TV 12/19/08
= IUP w/active fetus. |
|
|
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. |
|
|