Flu Vaccine

International Vaccination Newsletter

Influenza is a specific syndrome, provoked by a specific viral agent, the influenza virus. The symptoms may be severe, or even lead to exitus in people with a weakened general condition.

Two main families have been detected, influenza A and B. But there are many strains of influenza viruses, and, moreover, existing strains mutate all the time. It is, therefore, an extremely difficult task to 'foresee' the causative agent of a new influenza epidemic, and even more difficult to produce a corresponding vaccine in time. The constant mutation of the viruses, and the unpredictability of which virus will show up where and when, makes the whole influenza vaccination business into a giant poker game.

The most intriguing deception of the public, however, is the suggestion that the patient who gets an influenza-vaccination will not get the flu. What is generally known to the public as 'a flu' is an influenza-like syndrome, with symptoms like fever, chills, muskel- or joint pains, a headache, a runny nose, and general malaise. This disease, however, has got nothing to do with the real influenza, neither can it in any way be prevented by an influenza vaccination. Thus, if doctors guarantee their patients that they will not get the flu after they came in to get their jab, this is an unethical manipulation, the basis for which most probably is simply profit for both those who produce the vaccine and those who administer it.

Apart from this manipulation, questions have to be answered as to the efficacy and the safety of the vaccine.

Efficacy

The lack of efficacy of the vaccine is well illustrated in a Dutch article (1) about a home for elderly people, where in spite of vaccination of two thirds of the population, a severe flu struck 49% of them, with strong morbidity (bacterial infections, pneumonia) and high mortality (10%). An important observation was that in the vaccinated population, 50% got the disease, compared to 48% of non-vaccinated. Also, complement binding antibodies for influenza A were positive in 41% of vaccinated compared to 36% in non-vaccinated. This clearly shows that the vaccination status did not have a protective influence at all. Further laboratory investigation confirmed that antibody building against the vaccine was normal, but the causative influenza A virus had not reacted to the vaccine the patients had been given.

Comparison with a similar situation in 1988 in a home for elderly people shows that in that second case both morbidity and mortality were significantly lower, namely 37 and 3%, respectively. The main difference, however, was ... that in this second home patients had not been vaccinated!

Induction of antibodies in elderly people never is higher than 52-67% (2). Morris even declares the efficiency is not more than about 20% (3). Mistakes in production, transport, conservation and administration can be responsible for a further decrease of efficacy (4).

Safety

Questions about the safety of influenza vaccines are not new. As early as 1973, Rabin wrote that between 1966 and 1970 almost all USA-made influenza vaccines were toxic (5).

I. Neurological complications

For many years, neurological complications of influenza vaccination were simply denied. In 1966, Stuart-Harris wrote that "There is little direct evidence that any of these neurological illnesses during or after influenza are specifically caused by the influenza virus" (6). And in 1971, Wells still believed that "There is at present no way of proving or of disproving the aethiological relationship" (7).

Later on, USA studies proved that there was indeed a relationship between both. Observations during and after the A/New Jersey mass vaccination campaign in 1976 lead to convincing statistics (see GBS). German authors calculated the frequency of neurological complications at 1/0.7 million doses for influenza B vaccines and at 1/1.3 million vaccinations for influenza A vaccines (4). It is clear that for these figures, only documented cases have been taken into account, whereas as a rule not all cases have been properly diagnosed and reported. The real figures, thus, are likely to be higher. The first syndrome to be clearly correlated with the influenza-vaccination was the Guillain-Barre paralysis (1977). But only one year later, researchers discovered that neurological complications were not at all restricted to this one syndrome; on the contrary, they found a good number of neurological affections (8). Hennessen et.al. call the spectrum of syndromes "remarquably wide" and notice that in the course of a postvaccination disease process it is not rare for them to mingle into many different mixtures.

Although the first syndromes were detected after the A/New Jersey mass vaccination, complications after influenza vaccination can in no way be attributed or limited to this one vaccine. All 28 cases described by Hennessen et. al. e.g. were vaccinated with vaccines that did not contain this A/New Jersey strain.

More epidemiological data were gathered by Hennessen et al. The incidence of affections was significantly higher in autumn (September-November), four times more common in males than in females, in all age groups (16-73 years old) with an average age of 38,9 years. The interval between vaccination and first symptoms varied between 24 hours and 4 weeks, with an average of 11.3 days (8).

A. Paralysis

1) Guillain-Barre Syndrome (GBS)
The relationship between influenza-vaccination and GBS was proven after the 1976 A/New Jersey mass vaccination in the USA. In eleven states, comparable samples of vaccinated and non-vaccinated proved that in those vaccinated GBS occured in 1,55/million, compared to 0,17 in non-vaccinated (9,11 times more frequent in those vaccinated). (Hennessen quotes different figures: 8,0/million in vaccinated compared to 1,8/million in non-vaccinated 8). 31% of cases were over 60 years old. Only 12% occured within 7 days after vaccination, 74% between 8 and 28 days, and 14% even after one month 9. Most cases were diagnosed between 2 and 4 weeks after vaccination. Single cases occured up to 9 weeks after vaccination. Ehrengut & Allerdist mention that, within 3 weeks after vaccination, the frequency already is up to 3,12 cases per million vaccinees 4, which would raise the risk factor for vaccinees to 18,35.

Ehrengut and Allerdist describe a case which progressed from paralysis of the extremities to affection of the intercostal muscles and facial paralysis (4). This complication may occur in normal, healthy individuals without any preliminary disease.

More cases were described during an IABS Symposium in Geneva, 1977 (10).

2) Facialis paralysis
This symptom generally occurs as part of a Guillain-Barre Syndrome (4, 8). 3) Paralysis of the extremities
Paralysis of both upper limbs occured in a 40 year old man, with severe pain, atrophy of deltoideus muskles and hypoesthesia of the right arm after inoculation in the left upper arm (4).

Paresis of both lower limbs in a 58 year old man (4).

Wells describes two cases of myelitis transversa (7).

4) Landry syndrome (8)
5) Hypoglossus nerve paralysis (11)

B. Polyneuritis
Polyneuritis may occur in hands and feet, eventually accompanied of paralytic symptoms (4). Cases of polyradiculitis, polyradiculomyelitis and polyganglioradiculitis are documented.

1) Hypoesthesia
2) Paresthesia (formication and numbness) have been noticed (4, 8).
3) Neuralgia
a) Trigeminus neuralgia (8)
b) Ischialgia (right sided) (8)
c) Intercostal neuralgia (chestpain) (8)
d) Sensory brachial plexus neuropathy (Parsonage-Turner Syndrome) (8, 12, 13).

C. Meningitis
Meningeal infection and a stiff neck with positive lumbar punction can exist separately, or as part of a GBS syndrome (4).

D. Encephalitis
Encephalomyelitis and encephalopathy after influenza vaccination have been documented. A case was described by Ehrengut & Allerdist with loss of sight, then complete loss of consciousness and paralysis (4). Case 10 described by Hennessen had encephalitis with central disturbance of the N. Vestibularis (8). Also case 13 in the same study had encephalitis. Case 20 & 21 were diagnosed as meningoencephalomyelitis. Woods describes a case of encephalitis in a healthy seven year old girl in 1963 (14), Warren in 1956 (15), and another two cases were documented in 1962 (16).

E. Multiple Sclerosis
Some authors described a "recurrent encephalomyelitic syndrome" after vaccination (17, 18). Hennessen et al saw a similar case, where they were able to make the certain diagnosis of MS (8).

An exacerbation of symptoms was noticed in 1 out of 93 MS-patients vaccinated against influenza 19, 20.

F. Ataxia
Difficulties in walking in a 34 year old man were noticed, nine months after his influenza vaccination. The sensitive polyneuritis which also started shortly after vaccination had not subsided by that time. Right sided ataxia of lower limbs (8).

G. Headache
A strong headache (8) occuring within hours after vaccination is suggestive for meningeal or brain irriatation and deserves immediate further investigation.

H. Disorientation about places (8)

I. Unconsciousness
Multiple drop attacks occured in a case described by Stör & Mayer (21).

J. Trembling of upper limbs (21)

K. Automatic motions of fingers and toes (21)

L. Aphasia (loss of speech) (8)


II. Respiratory Infections

A. Bronchitis
A strong bronchitis with fever was noticed in a 29-year old man who also developed GBS later on (4).

B. Bronchopneumonia
This occured in a 41 year old man, where symptoms started with paresthesia of fingertips, and ended up with death, 4 weeks after vaccination. Pneumonia 14 days after vaccination (8).


III. Gastro-intestinal problems

A. Vomiting

This happened to a man 13 days after vaccination; paralytic symptoms were noticed later on (4).

B. Nausea (8)

C. Rectal incontinence (8)


IV. Urinary symptoms

Dysuria or paralysis of the bladder

Difficulties with urination bothered a man 13 days after vaccination; a distention of the bladder was diagnosed. Complete paralysis of the bladder with necessity of catheterisation followed. Paralytic symptoms of the extremities were noticed later on (4).


V. Sexual problems

Impotence

Lessening of sexual potency lasted for over 3 months in a patient who suffered GBS (4). Sexual impotence (4).


VI. ORL

A. Vertigo
Vertigo with tendency to fall to the right side, 5 days after vaccination, accompanied an encephalitis in an eighteen year old male 4. Vertigo with nystagmus, within minutes after vaccination, so strong that the 13 year old, healthy boy could not even stand up or sit anymore (4). Affection of the N. Vestibularis in combination with encephalitis (8).

B. Noises in the ears (8)

C. Impeded hearing (8)


VII. Eyes

A. Prooptosis (8)
B. Oedema of the retina (8)
C. Diminished vision; blurred vision (8)
D. Diplopia (8)
E. Nystagmus (8)
F. Paralysis of eye muscles (cranial nerves VII & IX) (8)


VIII. Circulatory problems

A. Collapse (8)
B. Transient livid discoloration of the hands (8).
C. Allergic thrombocytopenia in a 58 years old man 7 days after vaccination.

D. Disturbed blood pressure (both increased of decreased) (8).
E. Angor pectoris (8).
F. Collapse (8)
Hennessen et al describe some cases, both in elderly men with either hyper- or hypotonic crises, but also in a young man with ophistotonus, and tonic-clonic fits within minutes after vaccination.


IX. General symptoms

A. Fever
Fever occurs together with other syndromes, e.g. meningitis or GBS.

B. Somnolence
This may also be part of a larger neurological syndrome, such as GBS (4), (8).

C. Fatigue
Fatigue can be part of a general decrease of functional capacities (21).

Chronic fatigue is known to last for years after the infection subsided (4).

D. Anaphylactic reactions
Typical for anaphylactic reactions is the short incubation time.

Ehrengut & Allerdist describe such a reaction in an allergic person 1/2 h after vaccination (4). Warren describes a case where the reaction followed 4 to 5 hours after vaccination with fever, coryza and bronchospasms (15).


X. Mental problems

A. Difficulty in thinking (21)
B. Loss of initiative (21)
C. Confusion (14)
D. Hallucinations (14)


XI. Emotional problems

Sadness (21)


XII. Death

A 41 year old man died 4 weeks after vaccination, after progressive polyneuropathy and bronchopneumonia had developed (4). Death within 4 days (7).

Age Distribution

The many case descriptions available in medical literature prove that all age groups are susceptible to side effects.

Particularly important is the frequency of patients with serious side effects after the vaccine had been given for several years without any problem. This means that a lack of side effects after a vaccination is not a guarantee of safety of administration of the same vaccine in that patient later on.

From those who suffered GBS after vaccination, 11% were under 30 years of age, 58% were between 30 and 59, and 31% were 60 and more.

 


Etiology

Different mechanisms can play a role in the development of a post-vaccination neuropathy.

a) Hypersensitivity reactions of the nervous system (serogenetic) are responible in a good number of cases. Poser and Fowler describe similarities between GBS and serum disease.
b) Toxic reactions may occur soon after inoculation of the patient in the absense of specific allergies.
c) Viral infection of the brain by vaccinal viruses (4) or by reactivation of latent germs (21).
d) Activation of latent auto-immune diseases (21).

The fact that different vaccines from different manufacturers lead to similar complications, suggests that these are not the consequence of the impurity of a certain vaccine, but a risk inherent in any influenza vaccine.

Contra-Indications

Any impairment of the immune system should be considered a contra-indication.

1. Allergies, especially to any substance of the vaccines; allergy to proteins, cowsmilk etc.; hay fever... Allergic constitutions often lead to hypersensitive reactions (8).
2. Akute infections with or without fever must be a reason to postpone or abandon vaccination.
3. Chronic impairment of the immune system (auto-immune diseases) imply an increased risk in case of vaccination.

References

1. Beyer, W.E.P.; et. al. Influenza-epidemie in een verpleeghuis door een virus dat niet in het vaccin was opgenomen. Ned Tijdschr Geneeskd, 1993; 137/39:1973-7
2. Palache, A.M.; Influenza subunit vaccine - ten years experience. Eur J Clin Res, 1992; 3:117-38
3. Coulter, H.L.; Fisher, B.L. DPT, a shot in the dark, p 275. Harcourt Brace Jovanovich
4. Ehrengut, W.; Allerdist, H.; Über neurologische Komplikationen nach der Influenzaschutzimpfung. Münch. med. Wschr., 1977; 119/705-710 5. Rabin, J.; JAMA, 1973; 225:63
6. Stuart-Harris, C.H.; BMJ, 1966; 149:1(1966)217
7. Wells, C.E.C.; BMJ, 1971/2:755
8. Hennessen, W.; Jacob, H.; Quast, U.; Neurologische Affektionen nach Influenza - Impfung. Der Nervenarzt, 1978; 49/90-96
9. Morb. a. Mort.; Wkly Rep. 25 (1977) 430; 26 (1977) 7; 26 (1977) 52
10. Bryan, J.; Noble, G.R.; Guillain-Barré Syndrome after administration of killed vaccines. Genf: Ref: IABS Symposium on Influenza Immunization 1.6-4.6.1977
11. Felix, J.K.; Schwartz, R.H.; Myers, G.J.; Isolated Hypoglossal Nerve Paralysis Following Influenza Vaccination. Amer. J. Dis. Child., 1976; 130/1:82-3
12. Furlow, T.W.; Neuropathy after Influenza Vaccination. Lancet, 1977; i: 253
13. Schumm, F.; Neurologische Komplikationen nach Grippe-Impfung. Fragen aus der Praxis. Dtsch med Wschr, 1976; 101/18:720-21
14. Woods, C.A.; Ellison, G.W.; Encephalopathy following Influenza Immunization. J. Pediat., 1964; 65,5:745-8
15. Warren, W.R.; Encephalopathy due to Influenza Vaccine. A.M.A. Archives of Internal Medicine, 1956; 97:803
16. JAMA, 1962;181:70
17. Miller, H.; Cendrowski, W.; Schapira, K.; Multiple Sclerosis and Vaccinations. BMJ 1967;April 22: 210-3
18. Yahr, M.D.; Lobo-Antunes, J.; Relapsing Encephalomyelitis Following the Use of Influenza Vaccine. Arch Neurol, 1972; 27:182-3
Hennessen et al
19. Sibley, W.; Foley, J.; Infection and Immunization in Multiple Sclerosis. Ann Ac Sci fenn , 1965; A 122:457-68
20. Sibley, W.; Bamford, C.R.; Laguna, J.F.; Influenza vaccination in Patients with Multiple Sclerosis. JAMA, 1976; 236, 17:1965-66
21. Stöhr, M.; Mayer, K.; Neurologische Erkrankungen nach Grippeschutzimpfung. Med. Welt, 1976; 27/912-14