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Can Influenza Vaccine Cause Injury and Death?
The Institute of Medicine (IOM) has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination. However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving an influenza vaccine or any other vaccine.
The most common reported reactions following administration of the inactivated influenza vaccine include headache, muscle ache, fever, and pain, swelling and redness at the injection site.
Children who receive the influenza vaccine at the same time as the DTaP (diphtheria, tetanus, acellular pertussis) and/or pneumococcal (PCV13) are at a higher risk of suffering from a seizure induced by fever.
One of the most serious documented influenza vaccine reactions is Guillain-Barre Syndrome (GBS). An immune mediated painful and disabling neurological disorder that can occur after viral infection or vaccination, GBS involves inflammation of the peripheral nervous system and can cause temporary or permanent paralysis that may lead to death. GBS usually develops within two to four weeks of vaccination.
Characterized by muscle weakness, unsteady gait, numbness, tingling, pain, GBS can cause paralysis of the face or one or more limbs. It can take several months for recovery or it can leave the affected person with chronic health problems and disability. The mortality rate with GBS is highest among the elderly and those who develop severe complications.
The CDC states that:
“Some studies have found a possible small association of injectable flu vaccine with Guillain-Barré syndrome (GBS). Overall, these studies estimated the risk for GBS after vaccination as fewer than 1 or 2 cases of GBS per one million people vaccinated. Other studies have not found any association. GBS also, rarely, occurs after flu illness. Even though GBS following flu illness is rare, GBS is more common following flu illness than following flu vaccination. GBS has not been associated with the nasal spray vaccine.”
In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality, published in 2012 by the Institute of Medicine (IOM), 27 reported vaccine adverse events following the influenza vaccine were evaluated by a physician committee. These adverse events included GBS, stroke, myocardial infarction, Chronic Inflammatory Disseminated Polyneuropathy, Acute Disseminated Encephalomyelitis (ADEM), optic neuritis, Bell’s palsy, encephalopathy, encephalitis, and more.
The IOM committee concluded that in only 1 out of the 27-influenza vaccine-related adverse events – anaphylaxis - the scientific evidence convincingly supported a causal relationship between the vaccine and the adverse event. The committee also concluded that it favored acceptance of an association between the flu vaccine and Oculorespiratory Syndrome, a syndrome which generally occurs between 2- and 24-hours following vaccine administration and is characterized by symptoms which include acute respiratory symptoms (including respiratory distress, throat tightness and/or chest discomfort), red eyes, and facial swelling. After primarily examining epidemiologic studies, the committee members favored rejection of an association between 2 vaccine-related adverse events -Bell’s Palsy and asthma exacerbation or reactive airway disease episodes in children and adults- and the influenza vaccine. For the remaining 23 reported vaccine adverse events, including GBS, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the influenza virus vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination.
The U.S. government, however, recognized GBS occurring between 3 and 42 days following the influenza vaccine as a vaccine injury and in 2017, GBS was added to the National Vaccine Injury Compensation Program’s Vaccine Injury Table.
Adult influenza vaccine injury claims are now the leading claim submitted to the federal Vaccine Injury Compensation Program (VICP), with GBS as the leading alleged injury.
Additional influenza vaccine injuries recognized by the U.S. government and included in the Vaccine Injury Table include anaphylaxis within 4 hours of vaccination, vasovagal syncope within 1 hour of vaccination, and shoulder injury related to vaccine administration (SIRVA) within 48 hours of vaccination. SIRVA is a recognized injury resulting from the administration of the vaccine antigen or needle into or around the bursa of the shoulder. SIRVA causes an inflammatory response and manifests as pain and reduced mobility to the shoulder in which the vaccine was administered.
Published studies have linked the influenza vaccine to numerous serious adverse events including Acute Disseminated Encephalomyelitis (ADEM), stroke, brachial neuritis, encephalopathy, arthritis, bullous pemphigoid, vasculitis, , myocardial infarction, transverse myelitis, optic neuritis, Bell’s Palsy, and more.
A Canadian study published in 2015 found that the effectiveness of the flu vaccine decreased when a person received the shot two years in a row. Because of these negative findings which implied that the vaccine increased a person’s susceptibility to influenza, study authors recommended further research be completed.
In 2017, a Centers for Disease Control (CDC) funded study reported that women vaccinated in the early part of their pregnancy with a flu vaccine containing the pandemic H1N1 (H1N1pdm09) strain and who also had been previously vaccinated the prior season with a H1N1pdm09-containing flu vaccine had a greater risk of miscarriage in the first four weeks following vaccination. The CDC conducted further research among women who were pregnant during the 2012-2013 through 2014-2015 flu seasons and eligible to receive the flu vaccine. This study, which contradicted their previous findings, reported that the influenza vaccine did not cause miscarriages in the women evaluated in the study.
As of June 30, 2022, there have been more than 203,501 reports of influenza vaccine reactions, hospitalizations, injuries and deaths following influenza vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 2,202 related deaths, 15,729 hospitalizations, and 4,325 related disabilities. However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur after influenza vaccination.
Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.
As of July 1, 2022, there have been 8,614 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following influenza vaccination, including 218 deaths and 8,396 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 4,953 children and adults, who have filed claims for influenza vaccine injury.
IMPORTANT NOTE: NVIC encourages you to become fully informed about Influenza and the Influenza vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
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4 Kwong JC, Vasa PP. Campitelli MA. et al. Risk of Guillain Barre Syndrome after seasonal influenza vaccinations and influenza health care encounters: a self-controlled study. Lancet Infect Dis. Sept. 2013; 13(9): 769-776.
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