Reports of serious adverse events following immunization for influenza
and other diseases are collected by the Vaccine Adverse Events
Reporting System (VAERS) in the United States. This is a passive
surveillance system: it receives but does not seek reports from health
care professionals, patients, guardians, and other interested persons
concerning adverse events that might be connected to immunizations of
all kinds. N.B., certain listed events must be reported by law. There
is a similar system in Canada to report Vaccine Associated Adverse
Events (VAAE). This differs from the active surveillance system that
exists, for instance, in 12 of Canada's pediatric hospitals, IMPACT
(Immunization Monitoring Program, Active).
Serious neurological events have been reported following immunization
for influenza. By far, the most numerous event has been the increased
incidence of Guillain-Barré Syndrome (GBS), with the Swine Flu vaccine
administered in 1976-77 being the most clearly implicated. A number of
scientific studies since then have shown a slightly elevated risk of
Guillain-Barré associated with subsequent influenza immunization
programs, although greatly reduced when compared to the Swine Flu
program. In the general population .6 occurrences per million of
Guillain-Barré is the usually observed rate. In immunized populations,
based upon the VAERS records, studies have shown that the rate rises
to 1.7 cases per million. Thus, an increase of 1 case per million
doses is not unusual. Given the rarity of the syndrome, a statistical
correlation is difficult to make between influenza vaccine and the
small increased risk, although there is certainly reason to suspect
that a correlation does exist.
Guillain-Barré Syndrome is a rare paralytic illness, typically
beginning in the legs. Patients usually experience a full recovery.
An even more rare adverse event that has been reported post
immunization is Brown-Sequard syndrome, which sounds similar to the
diagnosis in this case.
CHECKLIST FOR INFORMED CONSENT
FOR HEALTH CARE PROVIDERS
http://www.gov.on.ca/health/english/program/pubhealth/flu/professionals/consent.pdf
"• Guillain Barre syndrome, or GBS, is a very uncommon disease, which
causes muscle paralysis and has been associated with certain
infectious diseases. It is not known whether influenza virus infection
itself is associated with GBS. Apart from the 1976-1977 swine flu
season, the risk of GBS associated with influenza vaccination is
small. Guillain Barre Syndrome(GBS) associated with influenza vaccine
was seen in only two of the six years studied in several US states
over the last two decades. During these two years, (1992-93 and
1993-94 seasons) the studies in four US states suggested slightly more
than 1 additional case of GBS per 1 million persons immunized against
influenza. In comparison, the risk of illness and death associated
with influenza is much greater.
• Because it is not known whether influenza immunization increases the
risk of recurrent GBS in persons who had GBS in the past, it is
recommended that persons who developed GBS within 6 to 8 weeks of a
previous influenza immunization should not be immunized against
influenza at this time. Reactions to influenza vaccine in the
2000-2001 and 2001-2002 influenza immunization seasons:
• An increased number of reports of generally mild and self-limiting
reactions following influenza vaccination occurred during the
2000-2001 immunization season in Canada while a decreased number of
reports is associated with the 2001-2002 immunization season."
Influenza Virus Vaccine
Fluzone®
2002 – 2003 Formula
http://www.vaccineshoppe.com/US_PDF/Fluzone_2002.2003.pdf
"WARNINGS
Fluzone should not be administered to individuals who have a prior
history of Guillain-Barré syndrome (GBS)."
[...]
"The 1976 swine influenza vaccine was associated with an increased
frequency of Guillain-Barré syndrome (GBS). 1,16
Among persons who received the swine influenza vaccine in 1976, the
rate of GBS that exceeded the background rate was <10 cases/1,000,000
persons vaccinated. Evidence for a causal relationship of GBS with
subsequent vaccines prepared from other influenza viruses is unclear.
Obtaining strong epidemiologic evidence for such a possible limited
increase in risk is difficult for such a rare condition as GBS, which
has an annual incidence of 10–20 cases/1,000,000 adults, and stretches
the limits of epidemiologic investigation.1
During three of four influenza seasons studied from 1977–1991, the
overall relative risk estimates for GBS after influenza vaccination
were slightly elevated but were not statistically significant in any
of these studies. However, in a study of the 1992–1993 and 1993–1994
seasons, the overall relative risk for GBS was 1.7 (95% confidence
interval = 1.0-2.8; p = 0.04) during the 6 weeks after vaccination,
representing approximately 1 additional case of GBS/1,000,000 persons
vaccinated. The combined number of GBS cases peaked two weeks after
vaccination. Thus, investigations to date indicate that there is no
substantial increase in GBS associated with influenza vaccines (other
than the swine influenza vaccine in 1976) and that, if influenza
vaccine does pose a risk, it is probably slightly more than 1
additional case/1,000,000 persons vaccinated. 1 Even if GBS were a
true side effect of vaccination in the years after 1976, the estimated
risk for GBS of approximately 1 additional case/1,000,000 persons
vaccinated is substantially less than the risk for severe influenza,
which could be prevented by vaccination in all age groups, especially
and chiefly persons aged 65 years and those who have medical
indications for influenza vaccination. 1 The potential benefits of
influenza vaccination in preventing serious illness, hospitalization,
and death greatly outweigh the possible risks for developing
vaccine-associated GBS. The average case-fatality ratio for GBS is 6%
and increases with age. No evidence indicates that the case-fatality
ratio for GBS differs among vaccinated persons and those not
vaccinated.1
The incidence of GBS among the general population is low, but persons
with a history of GBS have a substantially greater likelihood of
subsequently developing GBS than persons without such a history. Thus,
the likelihood of coincidently developing GBS after influenza
vaccination is expected to be greater among persons with a history of
GBS than among persons with no history of this syndrome. Whether
influenza vaccination specifically might increase the risk for
recurrence of GBS is not known.1
Neurological disorders temporally associated with influenza
vaccination such as encephalopathy, optic neuritis/neuropathy, 17,18
partial facial paralysis, and brachial plexus neuropathy have been
reported. However, no cause and effect has been established. 19,20
Almost all persons affected were adults, and the described clinical
reactions began as soon as a few hours and as late as 2 weeks after
vaccination. Full recovery was almost always reported. 14,21,22"
[...]
"REFERENCES
1. Recommendations of the Advisory Committee on Immunization Practices
(ACIP). MMWR 51: (RR03);1-31, 2002. 2. Mulloy E. Ir Med J Vol 89 (6):
202, 204, 1996. 3. Zimmerman RK, et al. Am Fam Physician 51 (4):
859-867, 1995. 4. Rothbarth PH, et al. Am J Respir Crit Care Med 151:
1682-1686, 1995. 5. Grilli G, et al. Eur J Epidemiol 13: 287-291,
1997. 6. Renton KW, et al. Can Med Assoc J 123: 288- 290, 1980. 7.
Fischer RG, et al. Can Med Assoc J 126: 1312-1313, 1982. 8. Lipsky BA,
et al. Ann Intern Med 100: 6: 835-837, 1984. 9. Kramer P, et al. Clin
Pharmacol Ther Vol 35, #3: 416-418, 1984. 10. Patriarca PA, et al. New
Engl J Med 308: 1601-1602, 1983. 11. Levine M, et al. Clin Pharm 3:
505-509, 1984. 12. Kilbourne ED. Vaccines (Plotkin and Mortimer eds.)
Saunders Company: 429, 1988. 13. ACIP. MMWR 35: 595-606, 1986. 14.
Barry DW, et al. Am J Epidemiol 104: 47-59, 1976. 15. Murphy KR, et
al. J Pediatr 106: 931- 933, 1985. 16. Schonberger LB, et al. Am J
Epidemiol 110: 105-123, 1979. 17. Hull TP, et al. Am J Opthalmol
703-704, 1997. 18. Kawasaki A, et al. J Neuro-Opthalmol: 18 (1),
56-59, 1998. 19. CDC. Surveillance Report No. 3, 1985-1986, Issued
February 1989. 20. Aventis Pasteur Inc., Data on File. MKT5720, 1994.
21. Retaillaiu HF, et al. Am J Epid III (3): 270-278, 1980. 22.
Guerrero IC, et al. N Engl J Med 300 (10): 565, 1979. 23. Kelsall JT,
et al. J Rheumatol 1198-1202, 1997. 24. CDC. MMWR 39: 730-733, 1990."
There is no reason why a reaction or suspected reaction to an
immunization should not be reported through VAERS. Anyone can submit a
report, either on paper or through the Web. Even if there is no proof
of an association between the immunization and the subsequent event, a
report can be made. It is only through the careful examination of the
reports that actual, as opposed to coincidental, linkages between
immunizations and adverse events can be determined to exist.
VAERS SITES
VAERS
Vaccine Adverse Events Reporting System
A Federal Program for Surveillance of Vaccine Safety
http://www.vaers.org/pdf/VAERS_brochure.pdf
Frequently Asked Questions
http://www.fda.gov/cber/vaers/faq.htm
The VAERS Web site
http://www.vaers.org
(Note the Web-based reporting option.)
VAERS Reporting Form
http://www.vaers.org/pdf/vaers_form.pdf
Data from the reports has been compiled into yearly databases that can
be downloaded via the Web. N.B., the data are stored in
self-extracting (.exe) compressed ZIP files. A Windows computer or a
software program capable of extracting the files is required, as well
as a database manager to view and search the records.
VAERS - Search VAERS Data
http://www.vaers.org/info.htm
Examples of reported influenza vaccine associated adverse events from
VAERS database for 2003. See Reporting Form for meaning of fields.
"195985 37629 SC 18 18 M 37629 20 minutes after recieving vacinnes,
patient fell onto padded matting with tachypneic respirations in
apparent respiratory distress with hives only on forehead, awake and
responsive with generalized twiching of upper extremities, C/O chest
pain. 50mg Ben 7 ANAPHYL ASTHMA DYSPNEA PAIN
CHEST TACHYCARDIA TWITCH URTICARIA Y Y Y 37628 37628 0 None
significant 3 FLU MEN TTOXA MIL MIL Tubersol (PPD)MFR-Aventis
LOT CO986AB placed left forearm at time of immunizations None worked
with a cardiologist for 5 years to determine cause of 6 syncope
episodes. No resolution,,
195704 37623 61 61 M 37609 Patient developed right subconjuctival
hemorrhage 3 hours after receiving vaccine. Patient reportedly
received no other medication prior to event. Patient was given
artificial tears to keep eyes moist. 60 day follwow up states assume
yes that pt has recov 1 HEM
EYE Y 37585 37585 0 Patient was told to
report to eye clinic for evaluation on 11/27/02 but lost to follow
up. 1 FLU UNK UNK NONE Hearing loss October 2002. Otherwise
reportedly healthy male. No allergies reported. Social history
unavailable.
195712 37623 WI 39 39 F Redness, edema on both injection
sites. 2 EDEMA INJECT SITE HYSN INJECT
SITE Y 37606 37607 1 NONE 2 FLU PPV PUB PVT Effexor,
Advair, Singular, Accupril PCN; Sulfa; Emycin; Tetracycline
195713 37623 GA 37 37 F 37608 Received flu shot 11/7/02 during shot
clinic. Developed decreased range of motion. No swelling. Saw doctor
12/9/02 X-ray was done. Celebrex was prescribed. Saw doctor again on
12/11/02. Has completed Celebrex; still having soreness in right
shoulder. 3 HYPOKINESIA MYALGIA PAIN Y U 37567 37567 0 X-ray
left shoulder 12/9/02. 1 FLU PUB PUB NONE NONE NONE GA02132
195714 37623 OR 32 32 F 37593 Patient received flu vaccine and about
7 minutes later, she complained of blurred vision, dizziness, and
tight chest. EMS was called. NP was 104/88, Pulse 80. EMS arrived and
assessed patient at about 16:12. Patient was feeling better; believed
she was ha 3 AMBLYOPIA DIZZINESS PAIN
CHEST Y 37593 37593 0 1 FLU PUB PUB NONE Asthma,
Anxiety OR200246
195715 37623 CA 50 49 F 37673 I woke up the next morning with cold
sweats, nauseated, very weak feeling. Lasting until the morning of
12/6/02. 3 ASTHENIA NAUSEA SWEAT Y 37594 37595 1 1 FLU UNK OTH Acyclovir NONE
195734 37623 MA 42 42 F 37614 Developed generalized itching two hours
after receiving fluzone. Notified employee health at 4:30pm. Benadryl
25mg ordered. Asumptematic on
11/5/02. 1 PRURITUS Y Y 37564 37564 0 1 FLU UNK PUB
195741 37623 SD 25 F 37621 Severe low abdominal pain; weak, blacked
out, sat down. Seen in ER. Rx painkillers. 3 ASTHENIA PAIN
ABDO SYNCOPE Y Y 1 FLU UNK UNK Orthotricycline NONE NONE
195749 37624 IL 0.7 0 0.7 M 37592 2 PARALYSIS THROM Y Y N 37567 37571 4 1 FLU PUB PUB IL02067
195751 37624 68 F 37550 Pr received a Pneumovax & flu injection
during her office visit. Pt states that 6 hours after receiving the
injection,she presented with sx - chills, sweats, lowgrafe fever,
nausea, arm pain, localized redness and swelling @ injection site,
Also c/o som 8 ARTHRALGIA CHILLS EDEMA INJECT SITE FEVER HYSN INJECT
SITE NAUSEA PAIN INJECT
SITE SWEAT Y Y 37546 37546 0 NONE 2 FLU PPV UNK UNK Pt
is allergic to Motrin& Sulfamethox & IVP Dye, History of benign Htn,
Diverticulosis, Mitral valve prolapse, Hyperlipedmia
195752 37624 OH 22 F 37617 Developed HA, nausea, about 9:30 pm same
day as vaccine. Vomiting started 10:45 am Friday 11/22/02 went to
emergenv room that evening, Seen by family physician doctor, Sunday
11/24/02 diarrhea lasting one day, Symptoms subsided
Monday 4 DIARRHEA HEADACHE NAUSEA VOMIT Y Y 37582 37582 0 1 FLU OTH PVT NONE
Known Leukemia, as child, Has been in remission > 5 yrs
195753 37624 CA 55 55 M 37619 Loss of equilibrium,ringing in the
ears, pain in right eye and in right side of brain, sensation of
bubbles in my right ankle,, mild chest, heart papitation, gritty
grinding noise like sand in my neck joint when I turn my
head 6 ATAXIA JOINT DIS PAIN EYE PAIN INJECT
SITE TACHYCARDIA TINNITUS Y 37580 37580 0 No
tests done 1 FLU UNK PVT (NONE taken on that day) Redness of
eyes, Aspergers Syndrome, hearing voices
195754 37624 OR 52 52 F 37620 Flu vaccine given 8-9 am on 11/07/02
15 mins later- HA,Vertigo,nausea, ''cold sweats" + advancing edema of
hand on arm , 15 mins after above vomiting,very unsteady on feet, Sent
to hospital ER 8 CHILLS DIZZINESS EDEMA
PERIPH HEADACHE NAUSEA SWEAT VERTIGO VOMIT Y Y 37567 37567 0 1 FLU OTH PVT Protonix,
Monopril 40mg NONE High B/P, Allergies, Codeine, Hydrocodone
195765 37624 ND 22 22 F 37624 Pt developed fever of 102 with swelling
in Left arm 3 by 3 inches. Was on her way to a European city mother
called on 1-2-03 with report and swelling increasing saw Dr in airport
and was given Benadryl.Mother called this am and pt arm swollen to
elbow now 2 EDEMA FEVER Y U 37620 37621 1 None
known 2 FLU PPV PUB PVT Alesse Lexapro None Depression Allergy
to Cephalexin
195795 37624 SC 60 60 M 37624 PATIENT RETURNED TO OUR OFFICE TODAY
WITH REDNESS & SWELLING AT INJECTION SITE. ALSO COMPLAINED OF EXTREME
NECK AND SHOULDER PAIN. NSAID,ANTISPASMOTIC,STERIOD GIVEN IN OFFICE
TODAY 3 EDEMA INJECT
SITE PAIN VASODILAT Y U 37621 37622 1 1 FLU PVT PUB PRAVACHOL,ATENOLOL,ASA,LISINOPRIL,
HYZAAR HYPERTENSION,HYPERCHOLESTEROLIMIA, SPASTIC PARAPLEGIA,OBESITY
195771 37627 MA 59 59 F 37617 Pain swelling induration at injection
site diagnosed as cellultiis. Negative blood cultures temp 100
deg-101.8 deg F. Clinically toxic. Treated with IV Kefzol. Discharged
on Augmentin. The discharge summary states chills, anorexia, nausea,
and pain. 11 ANOREXIA CELLULITIS CHILLS EDEMA INJECT SITE FEVER INJECT
SITE INDURAT INJECT SITE REACT LEUKOCYTOSIS NAUSEA PAIN PAIN INJECT
SITE Y 3 Y 37585 37586 1 WBC 34,300; 80 polys, 10
bands 1 FLU PVT PVT Fosamax 70mg weekly, Paxil 30mg po
qd Wellbutrin, depression
195772 37627 WI 50 50 F 37620 Low grade fever, pain. Shot received on
11/4/02. On 11/11/02 shot boosted immune system. Could not use arm,
shoulder shot was given in. MD removed fluid-? of infection. Had
arthroscopic surgery on 11/14/02-surgeon MD. Still has pain from
shoulder. 5 FEVER HYPOKINESIA INFECT LEUKOCYTOSIS PAIN Y Y 5 Y 37564 37571 7 WBC
19.6, no bacteria from site on 11/13/02; WBC increased
150,000. 1 FLU PVT OTH Synthroid, prednisone,
Methotryal Rheumatoid arthritis Thyroid removal, Skin Folliculitis
195775 37627 ME 12 12 M 37617 Left shoulder swelling, redness,
tenderness, nausea, malaise, fever to 102. Treated with IV and PO
antibiotics as cellulitis both complete
improvement. 7 CELLULITIS EDEMA FEVER MALAISE NAUSEA PAIN VASODILAT Y Y 37608 37610 2 CBC,
Blood culture, Throat culture, 2 FLU PPV PVT PUB Albuterol,
Singulair, Flovent, Immunotrigger NONE Asthma, Allergies
195781 37627 FL 1 0 F 37617 Broke out in macular papular lesions
12/25/2002 1 RASH VESIC
BULL U 35306 37615 2309 2 MMR VARCEL PVT PVT NONE Hx
of UTI, Urinary reflux
195779 37627 IL 73 74 F 37615 Patient was given pneumococcal vaccine
11/22/02. Patient stated after leaving the office she experieince a
red itchy rash and bumps. Area affected was chest, back and both arms.
Patient did not report this adverse reaction until a month later.
Patient fel 1 RASH MAC
PAP Y 37582 37582 0 2 FLU PPV UNK UNK IDDM,
HBP, Angina
195782 37627 FL 1 0 M Broke out in chicken
pox. 1 INFECT Y Y 37600 37619 19 3 FLU MMR VARCEL PVT PVT
195872 37627 IA 82 82 F 37627 PATIENT'S WHOLE BODY STARTED ITCHING
THE MORNING AFTER RECEIVING HER FLU
SHOT 1 PRURITUS Y 37572 37573 1 N/A 1 FLU UNK PVT UNKNOWN NONE
PER PATIENT'S DAUGHTER NONE"
From the above, one record,195749, shows a neurological reaction
(paralysis) associated with Fluzone.
Matching this record,
195749 37624 IL 0.7 0 0.7 M 37592 2 PARALYSIS THROM Y Y N 37567 37571 4 1 FLU PUB PUB IL02067
with the vaccine database records, the manufacturer is identified.
195749 FLU AVENTIS PASTEUR, U0946AA 0 RL INFLUENZA (FLUZONE)
The Food and Drug Administration’s Web site
http://www.fda.gov/cber/vaers/vaers.htm
The Centers for Disease Control and Prevention
http://www.cdc.gov/nip
Guidance on the types of events to report and criteria.
Reportable Events Table
http://www.vaers.org/pubs.htm
VAERS at 1-800-822-7967
e-mail inquiries: info@vaers.org
There is a program by which patients can be compensated for injuries
suffered from an immunization. The Vaccine Injury Table includes
haemophilus influenza type b (Hib).
Vaccine Injury Compensation Program (VICP)
HRSA - Office of Special Programs
http://www.hrsa.gov:80/osp/vicp/index.htm
Commonly Asked Questions
http://www.hrsa.gov:80/osp/vicp/QANDA.HTM
"4. Who may file a claim?
Any injured individual or a parent, legal guardian, or trustee of an
injured child or an incapacitated person may file a claim. A claim may
be made for any injury or death thought to be a result of a covered
vaccine. These injuries may include, but are not limited to:
anaphylaxis, paralytic polio, and encephalopathy."
[...]
"5. What is the time frame in which to file a claim?
For claims resulting from a vaccine administered on or after October
1, 1988, the following restrictions apply:
a. In the case of an injury, the effects must have continued at least
6 months after vaccine administration or the injury must have resulted
in inpatient hospitalization and surgical intervention and the claim
must be filed within 36 months after the first symptoms appeared.
b. In the case of a death, the claim must be filed within 24 months of
the death and within 48 months after the onset of the vaccine-related
injury from which the death occurred.
As of February 1, 1991, the time has expired for filing claims for
injuries or deaths resulting from vaccines administered prior to
October 1, 1988. Any claims filed for that time period are subject to
dismissal by the U.S. Court of Federal Claims (the Court)."
[...]
"9. How is eligibility for compensation determined?
There are three means to qualify for compensation:
a. A petitioner must show that an injury found on the Vaccine Injury
Table (the Table) occurred; or b. A petitioner must prove that the
vaccine caused the condition; or c. A petitioner must prove that the
vaccine significantly aggravated a pre-existing condition.
The Table lists specific injuries or conditions and the time frames in
which they must occur after vaccine administration. The Table is a
legal mechanism for defining complex medical conditions and allows a
statutory "presumption of causation." It is much easier to demonstrate
a "Table Injury" than to prove that the vaccine caused the condition,
and most claims allege that a Table Injury occurred. Compensation is
not awarded, however, if the Court determines that the injury or death
was due to a cause unrelated to the vaccine, even if it was a Table
Injury.
In contrast to civil liability suits, hearings to determine
eligibility under the VICP usually last only 1 or 2 days. A case found
eligible for compensation is scheduled for a hearing to assess the
amount of compensation. Most claims found to be noncompensable receive
awards for attorney's fees and costs."
[...]
"15. What adverse events are health care providers required to report?
The Vaccine Adverse Event Reporting System (VAERS), operated by the
Food and Drug Administration (FDA) and the CDC, should be notified of
any adverse event by completing a VAERS reporting form. The following
events are required to be reported:
a. Any event set forth in the Vaccine Injury Table that occurs within
the time period specified or within 7 days, if that is longer.
b. Any contraindicating event listed in the manufacturer's package
insert.
In addition, VAERS accepts all reports by any interested party of real
or suspected adverse events occurring after the administration of any
vaccine.
The VAERS form may be obtained by calling 1-800-822-7967 or from the
FDA Website at www.fda.gov/cber/vaers/report.htm.
Please note: Submitting a reporting form to VAERS in not the same as
filing a claim under the VICP as they are two separate programs."
VICP INJURY TABLE
National Childhood Vaccine Injury Act
Vaccine Injury Table
Effective August 26, 2002
http://www.hrsa.gov:80/osp/vicp/table.htm
"(2) Encephalopathy. For purposes of the Vaccine Injury Table, a
vaccine recipient shall be considered to have suffered an
encephalopathy only if such recipient manifests, within the applicable
period, an injury meeting the description below of an acute
encephalopathy, and then a chronic encephalopathy persists in such
person for more than 6 months beyond the date of vaccination.
(i) An acute encephalopathy is one that is sufficiently severe so as
to require hospitalization (whether or not hospitalization occurred).
(A) For children less than 18 months of age who present without an
associated seizure event, an acute encephalopathy is indicated by a
“significantly decreased level of consciousness” (see “D” below)
lasting for at least 24 hours. Those children less than 18 months of
age who present following a seizure shall be viewed as having an acute
encephalopathy if their significantly decreased level of consciousness
persists beyond 24 hours and cannot be attributed to a postictal state
(seizure) or medication.
(B) For adults and children 18 months of age or older, an acute
encephalopathy is one that persists for at least 24 hours and
characterized by at least two of the following:
(1) A significant change in mental status that is not medication
related; specifically a confusional state, or a delirium, or a
psychosis;
(2) A significantly decreased level of consciousness, which is
independent of a seizure and cannot be attributed to the effects of
medication; and
(3) A seizure associated with loss of consciousness.
(C) Increased intracranial pressure may be a clinical feature of acute
encephalopathy in any age group.
(D) A "significantly decreased level of consciousness" is indicated by
the presence of at least one of the following clinical signs for at
least 24 hours or greater (see paragraphs (2)(I)(A) and (2)(I)(B) of
this section for applicable timeframes):
(1) Decreased or absent response to environment (responds, if at all,
only to loud voice or painful stimuli);
(2) Decreased or absent eye contact (does not fix gaze upon family
members or other individuals); or
(3) Inconsistent or absent responses to external stimuli (does not
recognize familiar people or things).
(E) The following clinical features alone, or in combination, do not
demonstrate an acute encephalopathy or a significant change in either
mental status or level of consciousness as described above:
Sleepiness, irritability (fussiness), high-pitched and unusual
screaming, persistent inconsolable crying, and bulging fontanelle.
Seizures in themselves are not sufficient to constitute a diagnosis of
encephalopathy. In the absence of other evidence of an acute
encephalopathy, seizures shall not be viewed as the first symptom or
manifestation of the onset of an acute encephalopathy.
(ii) Chronic encephalopathy occurs when a change in mental or
neurologic status, first manifested during the applicable time period,
persists for a period of at least 6 months from the date of
vaccination. Individuals who return to a normal neurologic state after
the acute encephalopathy shall not be presumed to have suffered
residual neurologic damage from that event; any subsequent chronic
encephalopathy shall not be presumed to be a sequela of the acute
encephalopathy. If a preponderance of the evidence indicates that a
child's chronic encephalopathy is secondary to genetic, prenatal or
perinatal factors, that chronic encephalopathy shall not be considered
to be a condition set forth in the Table.
(iii) An encephalopathy shall not be considered to be a condition set
forth in the Table if in a proceeding on a petition, it is shown by a
preponderance of the evidence that the encephalopathy was caused by an
infection, a toxin, a metabolic disturbance, a structural lesion, a
genetic disorder or trauma (without regard to whether the cause of the
infection, toxin, trauma, metabolic disturbance, structural lesion or
genetic disorder is known). If at the time a decision is made on a
petition filed under section 2111(b) of the Act for a vaccine-related
injury or death, it is not possible to determine the cause by a
preponderance of the evidence of an encephalopathy, the encephalopathy
shall be considered to be a condition set forth in the Table.
(iv) In determining whether or not an encephalopathy is a condition
set forth in the Table, the Court shall consider the entire medical
record."
Data from the Weekly Morbidity and Mortality Reports concerning
immunization related events has been collected and analyzed, and are
available.
CDC Surveillance Summaries
Morbidity and Mortality Weekly Reports
http://www.cdc.gov/mmwr/mmwr_ss.html
Surveillance Summaries, January 24, 2003. MMWR 2003;52(No. SS-1)
http://www.cdc.gov/mmwr/PDF/ss/ss5201.pdf
"Influenza Vaccine and Guillain-Barré Syndrome
Vaccination with swine influenza vaccine is known to increase the risk
for Guillain-Barré syndrome (30–34). Reports of Guillain-Barré
syndrome after any vaccination are considered serious and followed up
by VAERS to obtain additional information. An increase in reports of
Guillain-Barré syndrome after the receipt of influenza vaccine was
noted in VAERS data by week 29 of the 1993–94 influenza season (35).
The number of reports increased from 23 during 1991– 92 to 40 during
1992–93 and to 80 during 1993–94 (Figure 5). These findings raised
concerns regarding a possible increase in vaccine-associated risk for
Guillain-Barré syndrome. A study was initiated to investigate the
VAERS signal (35). The study documented that the relative risk of
Guillain-Barré syndrome after influenza vaccination, adjusted for age,
sex, and vaccine season was 1.7 (95% confidence interval = 1.0–2.8).
How-ever, no increase occurred in the risk of vaccine-associated
Guillain-Barré syndrome from 1992–93 to 1993–94. For the two seasons
combined, the adjusted relative risk of 1.7 indi-cated that slightly
>1 additional case of Guillain-Barré syn-drome occurred per 1 million
persons vaccinated against influenza. This risk is less than the risk
from severe influenza, which can be prevented by the vaccine. In
addition, no corre-lation existed between the number of Guillain-Barré
syndrome reports received in VAERS and influenza vaccine doses
administered (Figure 5). The annual number of Guillain-Barré syndrome
reports has been low and stable during the previ-ous four influenza
seasons when the net doses of influenza vaccine distributed increased
substantially. This finding reflects data compared with the 1993–94
influenza season in which VAERS received the highest numbers of
Guillain-Barré syndrome reports in a single influenza season. This
example indicates that VAERS is useful in preliminary evaluation of
rare adverse events when the relation to vaccination is uncertain."
TABLE 1. CDC biologics surveillance data* — United States, 1991–2001
Total net doses distributed Ý
2000 2001 Total
________________________________
65,582,650 61,953,006 528,736,717
________________________________
* Personal communication, Lisa Galloway, National Immunization
Program, 2002.
Ý Total net doses of vaccine distributed equals the total doses
distributed by vaccine type and by year, less the doses returned.
TABLE 3 ( Continued). Vaccine Adverse Event Reporting System (VAERS)
reports and dose-based reporting rates for frequently reported vaccine
types* — United States, 1991–2001
_______________________________________________
Vaccine 2000 2001 1991–2001
typeÝ No. (%)§ No. (%) No. Rate ¶
FLU 1,771 (11.8) 1,674 (11.3) 15,652 3.1
_______________________________________________
* The frequently reported vaccine types were defined as the vaccine
types for which a total of >100 reports were received during
1991–2001.
Ý VAERS coding terms for vaccine types. See the Vaccine Codes Used in
This Report section for a description of each coding term. Each
vaccine type might represent similar vaccines from multiple vaccine
manufacturers. Vaccines were either reported alone or in combination
with other vaccines.
§ Percentages represent the proportion of reports concerning the
vaccine type among the total number of reports in each year.
¶ Number of reports per 100,000 net vaccine doses distributed. The
dose-based reporting rates were calculated using the 11-year
(1991–2001) total number of reports as numerators and the 11-year
total number of net doses of vaccines distributed (Table 1) as
denominators.
TABLE 7. Frequently reported adverse events* in the Vaccine Adverse
Event Reporting System (VAERS) — United States,
1991–2001
_________________________________
Adverse event No. (%)
_________________________________
Guillain-Barré syndrome 820 (0.6)
_________________________________
* Frequently reported adverse events were defined as the adverse
events that were mentioned in >100 VAERS reports during1991–2001. Each
report might include multiple adverse events. The percentages
represent the proportion of each frequently reported adverse event
among the total number of VAERS reports (128,717) during 1991–2001.
LITERATURE ON INFLUENZA VACCINES AND GUILLAIN-BARRÉ
PubMed SEARCH
http://ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
Search keywords: influenza vaccine Guillain Barre
(The following article is available online from the New England
Journal of Medicine after registration.)
Note that the authors have narrowed the criteria by which they
consider a correlation to have existed between immunization and the
onset of GBS. Most notably, they have shortened the time lapse from
eight to six weeks between the two events. Events occurring after 6-8
weeks of immunization ordinarily would not be considered to have a
cause and effect relationship.
The New England Journal of Medicine
Volume 339:1797-1802 December 17, 1998 Number 25
The Guillain–Barré Syndrome and the 1992–1993 and 1993–1994 Influenza
Vaccines
http://content.nejm.org/cgi/content/abstract/339/25/1797
"Guillain–Barré syndrome is characterized by loss of reflexes and
symmetric paralysis, usually beginning in the legs, with eventual
nearly complete or complete clinical recovery in most cases.1,2 It is
mediated by an immune response that results in the direct destruction
of either the myelin sheath surrounding the peripheral nerves or the
axon itself, and it may or may not follow triggering events, including
vaccinations.3,4 Among the vaccines reported to be associated with the
onset of Guillain–Barré syndrome are the swine influenza (A/ New
Jersey) vaccine in 1976–1977, oral poliovirus vaccine, and tetanus
toxoid.5 The association with the A/ New Jersey swine influenza
vaccine was notable for relative risks of Guillain–Barré syndrome
ranging from 4.0 to 7.6 for six- or eight-week periods after
vaccination.6,7,8,9,10 Subsequent studies of Guillain–Barré syndrome
and influenza vaccines found low relative risks of 1.4 in 1978–1979,
0.6 to 1.4 in 1979–1980 and 1980–1981, and 1.1 in 1980–1988; these
relative risks were not significantly different from 1.11,12,13 For
the 1990–1991 influenza season, an elevated risk was found among
vaccinated persons 18 to 64 years of age (relative risk, 3.0; 95
percent confidence interval, 1.5 to 6.3) but not among persons 65
years old or older.14
Reports of vaccine-associated Guillain–Barré syndrome are monitored by
the Vaccine Adverse Event Reporting System (VAERS) of the Centers for
Disease Control and Prevention (CDC) and the Food and Drug
Administration.15 An increase in the number of cases of Guillain–Barré
syndrome after the receipt of influenza vaccine was reported to VAERS
by week 29 of the 1993–1994 influenza season. The number increased
from 21 in 1991–1992 to 37 in 1992–1993 and to 74 in 1993–1994 (Figure
1).16 Because reports to the VAERS consist only of data on the number
of vaccine-associated cases without showing the number of people at
risk, the CDC and the University of Maryland School of Medicine
undertook a collaborative investigation to estimate the relative risks
associated with vaccination against influenza during the 1992–1993 and
1993–1994 seasons."
[...]
"Cases were categorized as definite, probable, or possible, as not
Guillain–Barré syndrome (noncases), or as requiring review by a
neurologist. In definite cases, other conditions were ruled out and
the patients were afebrile on admission (unless they had fever due to
an illness other than Guillain–Barré syndrome) and had symmetric,
progressive paralysis in more than one limb, areflexia or hyporeflexia
in the legs and arms, a cerebrospinal fluid protein level above 40 mg
per deciliter with a mononuclear-cell count of less than 10 per
milliliter, and either died or reached the peak of their neurologic
illness within four weeks of onset. Patients meeting all of these
criteria who did not have a lumbar puncture, the results of whose
cerebrospinal fluid tests were missing, or whose cerebrospinal fluid
mononuclear-cell count was between 11 and 50 per milliliter were
classified as probably having Guillain–Barré syndrome. Patients with
missing information for one or more of the required criteria were
classified as possibly having the syndrome. Patients whose charts
provided definitive information that they did not meet one or more of
the required criteria were classified as not having the syndrome. If
arm reflexes were normal or information on arm reflexes was missing
and if all other criteria were met, the chart was reviewed by the
study neurologist and the illness was categorized as a case or
noncase. Our algorithm for categorizing cases as definite or probable
was adapted from published criteria used by expert neurologists to
guide their review of cases. The definite and probable cases differ
only with respect to the completeness of cerebrospinal fluid
evaluation, which is not a required criterion for diagnosis of
Guillain–Barré syndrome. After implementing the computer algorithm, we
found that the completeness of cerebrospinal fluid evaluation was not
enough to distinguish definite from probable cases, and so we combined
the two groups."
[...]
"We estimate that after age, sex, and season have been controlled for,
the risk of the Guillain–Barré syndrome is increased by a factor of
1.7 in the six weeks after influenza vaccination. This is only
slightly higher than the relative risks reported in earlier studies of
influenza vaccine and Guillain–Barré syndrome, except for the much
higher risks associated with the swine influenza
vaccine.6,7,8,9,10,11,12,13,14 Although a variety of events are
associated with the Guillain–Barré syndrome, including vaccinations,
infection with Campylobacter jejuni, and viral infections, the
immunologic events leading to the Guillain–Barré syndrome have not
been fully described.24,25
We observed an average incidence of non–vaccine-associated
Guillain–Barré syndrome among adults of 0.145 case per million persons
per week, or a background incidence of 0.87 case per million persons
per six-week period. The age-, sex-, and season-adjusted relative risk
in the six-week period after vaccination was 1.7. Thus, the calculated
risk attributable to the vaccine in the six-week period after
vaccination was 0.61 case per million vaccinations. This estimate of
the vaccine-attributable risk is conservative because of four factors:
we received 92 percent of hospital charts, we did not include patients
hospitalized out of state, our base-line rate did not include patients
who were not interviewed, and our base-line rate did not include those
with possible cases of Guillain–Barré syndrome. After adjustment for
the first three factors, the best estimate of the attributable risk
would be 1.1 cases per million vaccinations. Thus, the adjusted
relative risk of 1.7 suggests that just over one additional case of
Guillain–Barré syndrome occurred per million vaccinations. Adjusting
for all four factors would increase the best estimate of attributable
risk to a maximum (if all were definite cases) of 1.6 cases per
million vaccinations."
OTHER LITERATURE
Ann Neurol 1982 Aug;12(2):119-28
Neurological complications of immunization.
Fenichel GM.
Vaccines prepared from whole, killed organisms (pertussis and possibly
influenza) may cause neurological allergic reactions producing
encephalopathy. These reactions are characterized by acute, monophasic
demyelinative processes and occur with no greater frequency than 1 per
100,000 vaccine recipients; onset is within 4 days of immunization,
and recovery is usually complete. No evidence suggests that these
vaccines produce an insidious, progressive encephalopathy. Only with
the swine influenza program of 1976 has Guillain-Barre syndrome
appeared to follow immunization. Vaccines prepared from
live-attenuated viruses (measles, mumps, rubella, and trivalent oral
poliovirus) can cause symptomatic viral infection of the nervous
system, including measles encephalitis, which occurs in 1 of 1,000,000
vaccine recipients; rubella neuritis, in less than 1 of 10,000
recipients; and paralytic poliomyelitis, in 1 of 3,000,000 vaccine
recipients or their close contacts. A cause-and-effect relationship
between immunization and brachial plexus neuritis, acute transverse
myelitis, and cranial neuropathies has been suggested but never
proved.
Publication Types: Review PMID: 6751212 [PubMed - indexed for MEDLINE]
Tex Med 2002 Jul;98(7):50-4
An analysis of the reactivity of vaccines administered in Texas from
1991 through 1999.
Geier DA, Geier MR.
MedCon, Inc, Silver Spring, Md., USA. mgeier@erols.com
Vaccination is one of the greatest advances in medical history.
Continued improvements in vaccination will include the introduction of
new vaccines and the improvement of the efficacy and safety of
existing vaccines. This report analyzes the 8623 reports made to the
Vaccine Adverse Events Reporting System from the state of Texas from
1991 through 1999. The severity, time of onset, and vaccine type of
the reactions, as well as the sex and age of those affected, were
examined. Physicians and other health care providers need to be
vigilant in their reporting of adverse reactions to vaccines. Persons
injured by vaccination should be referred to the National Vaccine
Injury Compensation Program.
PMID: 12134752 [PubMed - indexed for MEDLINE]
Semin Pediatr Infect Dis 2002 Jul;13(3):205-14
The science of evaluation of adverse events associated with
vaccination.
Halsey NA.
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205,
USA. nhalsey@jhsph.edu
All vaccines cause some adverse events; serious adverse events are
rare. Causal associations between a vaccine and an adverse event
rarely can be determined by specific tests such as identifying a
vaccine agent in the affected tissue of patients. In the absence of
such data, epidemiologic studies can be used to determine if the risk
of the disorder is increased in vaccinated compared to unvaccinated
individuals. Common mistakes include assuming a causal relationship
based on a temporal association only or a series of affected patients.
Careful studies have demonstrated that many hypothesized causal
associations between vaccines and adverse events were not
substantiated. False assumptions regarding causality are likely to
occur for illnesses without a carefully defined etiology or
pathogenesis.
Publication Types: Review
Review, Tutorial PMID: 12199617 [PubMed - indexed for MEDLINE]
Curr Opin Neurol 2002 Jun;15(3):333-8
Neurological adverse events associated with vaccination.
Piyasirisilp S, Hemachudha T.
Division of Neurology, Department of Medicine, Chiang Mai University,
Chiang Mai 50200, Thailand. spiyasir@mail.med.cmu.ac.th
Public tolerance to adverse reactions is minimal. Several reporting
systems have been established to monitor adverse events following
immunization. The present review summarizes data on neurologic
complications following vaccination, and provides evidence that
indicates whether they were directly associated with the vaccines.
These complications include autism (measles vaccine), multiple
sclerosis (hepatitis B vaccine), meningoencephalitis (Japanese
encephalitis vaccine), Guillain-Barre syndrome and giant cell
arteritis (influenza vaccine), and reactions after exposure to animal
rabies vaccine. Seizures and hypotonic/hyporesponsive episodes
following pertussis vaccination and potential risks associated with
varicella vaccination, as well as vaccine-associated paralytic
poliomyelitis following oral poliovirus vaccination, are also
described. In addition, claims that complications are caused by
adjuvants, preservatives and contaminants [i.e. macrophagic
myofasciitis (aluminium), neurotoxicity (thimerosal), and new variant
Creutzfeldt-Jakob disease (bovine-derived materials)] are discussed.
Publication Types: Review
Review, Tutorial PMID: 12045734 [PubMed - indexed for MEDLINE]
Eval Rev 1999 Dec;23(6):619-47
The swine flu vaccine and Guillain-Barre syndrome. A case study in
relative risk and specific causation.
Freedman DA, Stark PB.
University of California, Berkeley, USA.
Epidemiologic methods were developed to prove general causation:
identifying exposures that increase the risk of particular diseases.
Courts often are more interested in specific causation: On balance of
probabilities, was the plaintiff's disease caused by exposure to the
agent in question? Some authorities have suggested that a relative
risk greater than 2.0 meets the standard of proof for specific
causation. Such a definite criterion is appealing, but there are
difficulties. Bias and confounding are familiar problems; individual
differences must be considered too. The issues are explored in the
context of the swine flu vaccine and Guillain-Barre syndrome. THE
CONCLUSION: There is a considerable gap between relative risks and
proof of specific causation.
PMID: 10662072 [PubMed - indexed for MEDLINE]
J Autoimmun 2000 Feb;14(1):1-10
Vaccination and autoimmunity-'vaccinosis': a dangerous liaison?
Shoenfeld Y, Aron-Maor A.
Department of Internal Medicine B, Sheba Medical Center, Tel Hashomer,
Israel. shoefel@post.tau.ac.il
The question of a connection between vaccination and autoimmune
illness (or phenomena) is surrounded by controversy. A heated debate
is going on regarding the causality between vaccines, such as measles
and anti-hepatitis B virus (HBV), and multiple sclerosis (MS). Brain
antibodies as well as clinical symptoms have been found in patients
vaccinated against those diseases. Other autoimmune illnesses have
been associated with vaccinations. Tetanus toxoid, influenza vaccines,
polio vaccine, and others, have been related to phenomena ranging from
autoantibodies production to full-blown illness (such as rheumatoid
arthritis (RA)). Conflicting data exists regarding also the connection
between autism and vaccination with measles vaccine.So far only one
controlled study of an experimental animal model has been published,
in which the possible causal relation between vaccines and autoimmune
findings has been examined: in healthy puppies immunized with a
variety of commonly given vaccines, a variety of autoantibodies have
been documented but no frank autoimmune illness was recorded. The
findings could also represent a polyclonal activation (adjuvant
reaction). The mechanism (or mechanisms) of autoimmune reactions
following immunization has not yet been elucidated. One of the
possibilities is molecular mimicry; when a structural similarity
exists between some viral antigen (or other component of the vaccine)
and a self-antigen. This similarity may be the trigger to the
autoimmune reaction. Other possible mechanisms are discussed.Even
though the data regarding the relation between vaccination and
autoimmune disease is conflicting, it seems that some autoimmune
phenomena are clearly related to immunization (e.g. Guillain-Barre
syndrome).The issue of the risk of vaccination remains a philosophical
one, since to date the advantages of this policy have not been
refuted, while the risk for autoimmune disease has not been
irrevocably proved. We discuss the pros and cons of this issue
(although the temporal relationship (i.e. always 2-3 months following
immunization) is impressive). Copyright 2000 Academic Press.
Publication Types: Review
Review, Tutorial PMID: 10648110 [PubMed - indexed for MEDLINE]
Am J Epidemiol 1991 May 1;133(9):952-5
Comment in: Am J Epidemiol. 1992 Aug 1;136(3):374-6. Guillain-Barre
syndrome and influenza vaccination in the US Army, 1980-1988.
Roscelli JD, Bass JW, Pang L.
Department of Pediatrics, Tripler Army Medical Center, Honolulu, HI
96859-5000.
An increased incidence of Guillain-Barre syndrome
(polyradiculoneuritis) occurred in individuals who received the A/New
Jersey (swine) influenza vaccine in 1976-1977. A retrospective study
encompassing the years 1980-1988 was conducted to determine if the US
Army's mass influenza vaccination program has been associated with an
increased incidence of Guillain-Barre syndrome in active duty soldiers
during the study years. No temporally related increase in
Guillain-Barre syndrome was found during the study years.
PMID: 2028981 [PubMed - indexed for MEDLINE]
Am J Epidemiol 1991 May 1;133(9):940-51
Reassessment of the association between Guillain-Barre syndrome and
receipt of swine influenza vaccine in 1976-1977: results of a
two-state study. Expert Neurology Group.
Safranek TJ, Lawrence DN, Kurland LT, Culver DH, Wiederholt WC, Hayner
NS, Osterholm MT, O'Brien P, Hughes JM.
Hospital Infections Program, Centers for Disease Control, Atlanta, GA.
Although the original Centers for Disease Control study of the
relation between A/New Jersey/8/76 (swine flu) vaccine and
Guillain-Barre syndrome (polyradiculoneuritis) demonstrated a
statistical association and suggested a causal relation between the
two events, controversy has persisted. To reassess this association,
the authors obtained medical records of all previously reported adult
patients with Guillain-Barre syndrome in Michigan and Minnesota from
October 1, 1976 through January 31, 1977. To identify previously
unreported hospitalized cases with onset of symptoms during this
period, the authors surveyed medical care facilities. A group of
expert neurologists formulated diagnostic criteria for Guillain-Barre
syndrome and then reviewed the clinical records in a blinded fashion.
Of the 98 adult patients from the original Centers for Disease Control
study eligible for consideration, three were found to have been
misclassified by date of onset and were excluded. Of the remaining 95,
the 28 (29%) who did not meet the diagnostic criteria were equally
distributed between the vaccinated group (18 of 60, 30%) and the
unvaccinated group (10 of 35, 29%). In addition to the 67 remaining
cases who met the diagnostic criteria, six previously unreported cases
(three of whom had been vaccinated) were found and included in this
analysis. The relative risk of developing Guillain-Barre syndrome in
the vaccinated population of these two states during the 6 weeks
following vaccination was 7.10, comparable to the relative risk of
7.60 found in the original study. These findings suggest that there
was an increased risk of developing Guillain-Barre syndrome during the
6 weeks following vaccination in adults. The excess cases of
Guillain-Barre syndrome during the first 6 weeks attributed to the
vaccine was 8.6 per million vaccinees in Michigan and 9.7 per million
vaccinees in Minnesota. No increase in relative risk for
Guillain-Barre syndrome was noted beyond 6 weeks after vaccination.
PMID: 1851395 [PubMed - indexed for MEDLINE]
Medicina (Firenze) 1990 Apr-Jun;10(2):169
[Influenza vaccination and polyradiculoneuritis of the Guillain-Barre
type]
[Article in Italian]
Pelosio A, Galassi A, Massini R, Longhi C, Marchetti P, Recine U.
III Divisione Medica, Ospedale S. Spirito, Roma.
The Authors present a Guillain-Barre like case of polyradiculoneuritis
occurring two weeks after the 1988-89 influenza vaccination. The
existence of similar cases recently reported in the literature and
their frequent association with swine influenza vaccination suggest
the opportunity of a better epidemiological survey of similar cases.
PMID: 2273957 [PubMed - indexed for MEDLINE]
Neurology 1987 Apr;37(4):685-8
Risk factors for Guillain-Barre syndrome.
Kaslow RA, Sullivan-Bolyai JZ, Holman RC, Hafkin B, Dicker RC,
Schonberger LB.
In 100 cases of Guillain-Barre syndrome (GBS) reported from 10
metropolitan areas to the Centers for Disease Control (CDC) after the
1976-77 influenza vaccination campaign and matched associate or spouse
controls, we searched for risk factors for GBS other than A/New
Jersey/1976 influenza vaccination and acute respiratory infection. The
47 vaccinated cases recalled influenza vaccination in past years less
frequently than did controls (p less than 0.025). Cases and controls
did not differ in the number of previous vaccinations or in interval
from last vaccination. Cases also gave a history of allergy less
frequently than controls. There were no other significant differences.
PMID: 3561781 [PubMed - indexed for MEDLINE]
RESULTS FROM CANADIAN REPORTS FOR 2001-2002
INFLUENZA VACCINE-ASSOCIATED ADVERSE EVENTS: RESULTS OF PASSIVE
SURVEILLANCE, CANADA 2001-2002
http://www.hc-sc.gc.ca/pphb-dgspsp/publicat/ccdr-rmtc/02vol28/dr2823ea.html
"The serious adverse events reported were anaphylaxis (9 per 10
million doses distributed), Guillain-Barré syndrome (1 per 3 million
doses distributed), convulsions (1 per 3 million doses distributed),
paralysis (1 per 2.5 million doses distributed), and
meningitis/encephalopathy (1 per 3 million doses distributed)."
[...]
"Serious adverse reactions include Guillain-Barré syndrome, although
no causal association has been documented(8). Other neurologic
disorders following influenza vaccination include encephalopathy,
facial paralysis, paresthesia, and convulsions(9). There have been
occasional reports of Bell’s palsy and ocular effects(10). There was
increased reporting of ocular and respiratory symptoms following
influenza vaccination in 2001-2002 in Canada, but the rate was lower
than that observed during 2000-2001(1)."
[...]
Table 1. Adverse events reported following administration of influenza
vaccine, Canada 2001-2002
Number % of
of total Rate per
adverse adverse million doses
Adverse event events events* distributed
Paralysis limb/facial/cranial 4 0.2 0.4
Guillain-Barré syndrome 3 0.2 0.3
Convulsions/seizures – febrile or afebrile 5 0.3 0.5
Meningitis/encephalitis
/encephalopathy/encephalomyelitis 5 0.3 0.5
[...]
Neurological symptoms 196 ** 19.9
Myelitis 1 0.1 0.1
Paresthesia 85 4.7 8.6
Paralysis 4 0.2 0.4
Other: agitation,
impaired concentration, confusion, 106 5.9 10.8
abnormal coordination, abnormal crying, delirium, depression,
diplopia, dysasthesia, dyskinesia, euphoria, fall, gait abnormal,
hallucination, insomnia, nervousness, somnolence, vertigo, tremors,
stupor, hypertonia, hypoesthesia, hypokinesia, anxiety, ataxia
LITERATURE CONCERNING INFLUENZA INOCULATION AND ENCEPHALOPATHY
PubMed Search Terms
influenza vaccine encephalopathy
J Natl Med Assoc 1995 Sep;87(9):705-8
Postvaccinial (influenza) disseminated encephalopathy (Brown-Sequard
syndrome).
Antony SJ, Fleming DF, Bradley TK.
Department of Internal Medicine, East Carolina University School of
Medicine, Greenville, North Carolina, USA.
This article reports a case of Brown-Sequard syndrome that occurred in
a patient following the administration of trivalent influenza vaccine.
The patient responded well to intravenous steroids and physical
therapy. This is the first reported case in the literature.
Publication Types: Review
Review of Reported Cases PMID: 9583968 [PubMed - indexed for
MEDLINE]
Brain Dev 1985;7(4):449-53
A case of a rapidly progressive central nervous system disorder
manifesting as a pallidal posture and ocular motor apraxia.
Morimoto T, Oguni H, Awaya Y, Hayakawa T, Fukuyama Y.
We report a case of a rapidly progressive central nervous system
disorder, in which the outstanding clinical features were ocular motor
apraxia and a pallidal posture. The etiology remains unknown except
for the possibility of post-influenza immunization encephalopathy.
PMID: 4061785 [PubMed - indexed for MEDLINE]
Arch Neurol 1978 Mar;35(3):166-70
Recurrent disseminated vasculomyelinopathy.
Poser CM, Roman G, Emery ES 3rd.
The monosymptomatic (recurrent infantile hemiplegia) and the
polysymptomatic forms of disseminated vasculomyelinopathy that follow
various infections and antigenic challenge to the nervous system were
seen in two cases. These cases emphasize the importance of
vasculopathy as the initial and obligatory component of the
postinfectious and postimmunization neurologic syndromes as well as
the clinical and pathological variability of the secondary effects on
the nervous system. Recurrent infantile hemiplegia occurred in the
first patient. In the second patient, after two episodes of
postinfectious myelinoclastic encephalopathy, concurrent acute
hemorrhagic leukoencephalopathy and an acute Guillain-Barre syndrome
following swine flu vaccination developed.
PMID: 629662 [PubMed - indexed for MEDLINE]
Neuroepidemiology 1985;4(3):138-45
Spontaneous infection or vaccination as cause of acute disseminated
encephalomyelitis.
Murphy J, Austin J.
This report describes an approach to determine which of 2 possible
etiologies could be responsible for a disease, in this instance acute
disseminated encephalomyelitis (ADEM). Information about latency
periods was obtained from eighteen reference sources in the
literature. Analysis of these data indicate that it would be 9-18
times more likely for ADEM to develop 5 days after a wild virus
infection (measles, for example) than 28 days after a vaccination.
PMID: 2870439 [PubMed - indexed for MEDLINE]
Eur J Neurol 2000 Nov;7(6):731-3
Myelopathy following influenza vaccination in inflammatory CNS
disorder treated with chronic immunosuppression.
Larner AJ, Farmer SF.
Department of Neurology, St Mary's Hospital, Praed Street, London, UK.
larner-a@wcnn-tr.nwest.nhs.uk
We report a patient who developed a transverse myelitis with
Brown-Sequard syndrome following a prophylactic influenza vaccination,
despite being chronically immunosuppressed for a steroid-responsive
optic neuropathy. Although influenza vaccination is recommended in
patients receiving chronic immunosuppression, its use may on occasion
be associated with neurological complications previously reported in
immunocompetent individuals.
PMID: 11136365 [PubMed - indexed for MEDLINE]
SEARCH TERMS
://www.google.com/search?hl=en&lr=&ie=ISO-8859-1&q=Aventis+Fluzone+Guillain+Barre
://www.google.com/search?hl=en&lr=&ie=ISO-8859-1&q=influenza+vaccine+Guillain+Barre
://www.google.com/search?hl=en&lr=&ie=ISO-8859-1&q=CDC+vaccine+adverse+events+report
Proving a linkage between influenza vaccination and a neurological
adverse event is difficult but not impossible. A probability range of
linkage is likely to be the most that can be hoped to be established.
The greater the amount of data that can be provided, the better the
chance that the probability of linkage can be raised. In this case,
the battery of tests that were performed and the resulting data should
provide the basis for a thorough review. In addition, the extensive
diagnostic process of elimination that has already occurred will be
invaluable in making any linkage between the immunization and the
onset of the symptoms.
Good luck.
The above dose not constitute either medical or legal advice, cannot
substitute for advice from competent experts, and should not be
construed as such. All Google disclaimers apply.
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