Institute for Vaccine Safety

Category: Vaccine Safety Topics

  • Do Vaccines Cause Seizures?

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    Conclusion Fever is a common symptom of many natural infections, including bacteria such as diphtheria, pertussis, meningococcus and pneumococcus, and viruses such as hepatitis A, hepatitis B, influenza, measles mumps, rubella, polio, rotavirus and varicella. Fever is associated with febrile seizures in infants. Thus, many vaccines prevent fever and febrile seizures by protecting against natural…

  • Do Vaccines Cause Meningitis or Encephalitis/Encephalopathy?

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    Conclusion Varicella vaccine in routine use in the United States28F* can very rarely cause viral meningitis. Measles-containing vaccines can very rarely cause measles inclusion body encephalitis (MIBE). Mumps vaccines used in other countries have caused meningitis and encephalitis. However, the mumps vaccine in routine use in the United States* is made from a different strain…

  • Do Vaccines Cause Herpes Zoster?

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    Conclusion Varicella vaccines can rarely cause herpes zoster due to vaccine-strain viral reactivation. Other vaccines currently routinely recommended to the general population in the U.S.* do not cause vaccine-strain viral reactivation. Epidemiological Evidence  The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), described one study assessing varicella…

  • Do Vaccines Cause Hepatitis?

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    Conclusion Natural infection with hepatitis viruses is known to cause hepatitis disease. Natural infection with measles, mumps, rubella and varicella viruses have also been associated with hepatitis, albeit rarely. Thus, measles, mumps, rubella and varicella vaccines, and especially hepatitis A and hepatitis B vaccines, prevent hepatitis disease by protecting against natural infection. Vaccines currently routinely…

  • Do Vaccines Cause Disseminated Varicella Infection?

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    Conclusion Disseminated varicella infection is a serious potential complication of natural infection with varicella virus, particularly among immunodeficient persons. Thus, varicella vaccine prevents disseminated varicella infection by protecting against natural infection. However, varicella vaccines can rarely cause disseminated varicella infection in patients with severe immune deficiency, for whom the vaccine is contraindicated. Other vaccines currently…

  • Do Vaccines Cause Ataxia?

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    Conclusion Natural mumps and varicella infections are associated with acute cerebellar ataxia. Thus, mumps and varicella vaccines prevent ataxia by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause ataxia. Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM), now called…

  • Do Vaccines Cause Hypersensitivity Reactions?

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    Conclusion Vaccines can very rarely cause immediate hypersensitivity reactions (i.e. anaphylaxis, angioedema, and/or hives) usually within minutes, but up to several hours of vaccination in persons with allergy to a vaccine component. Also, vaccines can cause large local swelling reactions or nodules at the injection site due to delayed-type hypersensitivity reactions. International consensus for evaluation…

  • Do Vaccines Cause Autism?

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    Conclusion Childhood vaccines do not cause autism.  Maternal vaccines have not been shown to cause autism. The Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), concluded that the body of evidence favors rejection of a causal relationship between autism and MMR vaccine and thimerosal-containing vaccines.1,2 MMR vaccine also prevents rubella disease,…

  • Do Vaccine Ingredients Cause Adverse Events?

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    Conclusion Certain ingredients that are present in some vaccines (other than disease-specific antigens), such as gelatin or neomycin, can very rarely cause severe hypersensitivity reactions (e.g. anaphylaxis) in vaccinees with those specific allergies. In addition, some adjuvants can cause increased rates of local reactions, and alum-containing adjuvants can cause nodules at the injection site. Vaccine ingredients, including the preservative thimerosal, do not…

  • Do Combination Vaccines or Simultaneous Vaccination Increase the Risk of Adverse Events?

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    Conclusion Certain combination vaccines or simultaneous administration of vaccines that are known to cause fever can rarely cause febrile seizures in infants and young children beyond the risk presented by individually administered vaccines. Specifically, the rate of febrile seizures in the 7-10 days after vaccination was approximately 2-3 times higher for children who received MMRV…

  • Do Vaccines Cause Myocarditis and/or Myocardopathy/Cardiomyopathy?

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    Conclusion Myocarditis can be induced by either viral or bacterial infection, most notably developing in up to two thirds of persons infected with diphtheria. Thus, diphtheria vaccine prevents myocarditis by protecting against natural infection. Smallpox vaccine can very rarely cause myocarditis and myocardiopathy/cardiomyopathy, but is not routinely recommended to the general population in the United…

  • Do Vaccines Cause Guillain-Barré Syndrome?

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    Conclusion Influenza vaccines reduce the risk of influenza infection, which causes Guillain-Barré syndrome (GBS). Thus, influenza vaccines prevent GBS by protecting against natural influenza infection. However, influenza vaccines can very rarely cause GBS within 6 weeks of vaccination in adults, at an estimated rate of 1-3 cases per million vaccinations. Influenza vaccines have not been…

  • Establishing Ongoing Funding for Post-Authorization Vaccine Safety Science

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    download a pdf of this information

  • Potential Adverse Events Following Immunization

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    Summaries of the Evidence This section addresses the numerous potential adverse events that have been studied in order to determine if an association exists with routine immunization in the United States, and supplements the vaccine information summaries for those seeking more information about a specific adverse event. The independent 2012 report by the Institute of…

  • Do Vaccines Cause Vasculitis or Polyarteritis Nodosa?

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    Vaccines currently routinely recommended to the general population in the U.S have not been shown to cause vasculitis or PAN.

  • Do Vaccines Cause Transverse Myelitis?

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    Conclusion Natural viral infections with influenza, hepatitis A, measles, mumps and rubella and varicella have all been associated with transverse myelitis, albeit rarely. Thus, these viral vaccines may prevent transverse myelitis by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause transverse myelitis.…

  • Do Vaccines Cause Thrombocytopenia or Immune Thrombocytopenic Purpura?

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    Conclusion Natural viral infections such as influenza, varicella, measles, mumps and rubella are associated with immune thrombocytopenic purpura (ITP). Thus, influenza, varicella, measles, mumps and rubella vaccines prevent ITP by protecting against natural infection. Measles-containing vaccines can very rarely cause ITP within 6 weeks of vaccination in children. However, these vaccines prevent many more cases…

  • Do Vaccines Cause Systemic Lupus Erythematosus?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause systemic lupus erythematosus (SLE). Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM) 1, now called the National Academy of Medicine (NAM), described four studies assessing exacerbation of SLE and influenza vaccine 2-5 and one…

  • Do Vaccines Cause Syncope?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* can rarely cause syncope up to an hour after vaccination, most frequently among adolescents, and especially among females 11-18 years of age. Potential injury from syncope after vaccination can be prevented by careful monitoring of vaccine recipients and having them sit or lay…

  • Do Vaccines Cause Sudden Infant Death Syndrome (SIDS)?

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    Conclusion DTP and hepatitis B vaccines do not cause sudden infant death syndrome (SIDS). Other vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause SIDS. Epidemiological evidence In a 2003 report entitled Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy, the Institute of Medicine (IOM),…

  • Do Vaccines Cause Spontaneous Abortion?

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    Conclusion Vaccines currently routinely recommended for pregnant individuals in the U.S. have not been shown to cause spontaneous abortion (SAb). Why This Is An Issue The Advisory Committee on Immunization Practices (ACIP) and the American College of Obstetricians and Gynecologists (ACOG) recommend that “all women who are pregnant or who might be pregnant or postpartum…

  • Do Vaccines Cause Small Fiber Neuropathy?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause small fiber neuropathy (SFN). Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), found no relevant studies of quality in the literature assessing SFN and varicella or…

  • Do Vaccines Cause Serum Sickness?

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    Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause serum sickness.

  • Do Vaccines Cause Primary Ovarian Insufficiency?

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    The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), did not assess POI as a potential outcome of vaccination.

  • Do Vaccines Cause Opsoclonus Myoclonus Syndrome?

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    Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause OMS.

  • Do Vaccines Cause Optic Neuritis or Neuromyelitis Optica?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause optic neuritis or neuromyelitis optica (NMO). Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM) 1, now called the National Academy of Medicine (NAM), described two studies assessing optic neuritis and MMR, influenza, hepatitis B,…

  • Do Vaccines Cause Oculorespiratory Syndrome?

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    Conclusion The Fluviral S/F® and Vaxigrip® vaccines used in Canada between 2000 and 2003 (but never used in the United States) did commonly cause oculorespiratory syndrome (ORS) within 24 hours of vaccination, at an estimated rate of up to 2.9 cases per 100 vaccinations. Changes have been made in the formulation of these vaccines that…

  • Do Vaccines Cause Narcolepsy?

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    Conclusion The AS03-adjuvanted 2009 pandemic H1N1 influenza vaccine (trade name: Pandemrix™) was associated with an increased risk of narcolepsy in several northern European countries. In other countries where there is a lower prevalence of genetic factors associated with narcolepsy, studies did not find an increase in risk with this vaccine or other influenza vaccines. The…

  • Do Vaccines Cause Myocardial Infarction or Stroke?

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    Conclusion Myocardial infarction (MI) has been associated with natural influenza infection, and stroke has been associated with natural varicella infection, albeit both very rarely. Thus, influenza vaccine prevents MI and varicella vaccine prevents stroke by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to…

  • Do Vaccines Cause Multiple Sclerosis?

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    Conclusion Influenza vaccines do not cause multiple sclerosis (MS).Other vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause MS. Epidemiological Evidence Most studies described in the 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), found no association between vaccination…

  • Do Vaccines Cause Hearing Loss?

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    Conclusion Natural infections with viruses such as measles and mumps have been associated with both transient and permanent hearing loss. Thus, measles and mumps vaccines prevent such hearing loss by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause hearing loss. Epidemiological Evidence…

  • Do Vaccines Cause Fibromyalgia or Chronic Fatigue Syndrome?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause fibromyalgia or chronic fatigue syndrome (CFS). Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), found no relevant studies of quality in the literature assessing an association…

  • Do Vaccines Cause Facial Nerve Palsy?

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    Conclusion Natural infections with varicella, tetanus and diphtheria have each been associated with facial nerve palsy. Thus, varicella, tetanus and diphtheria vaccines prevent facial nerve palsy by protecting against these natural infections. Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause facial nerve palsy. Epidemiological Evidence The…

  • Do Vaccines Cause Erythema Nodosum?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause erythema nodosum (EN). Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), found no relevant studies of quality in the literature assessing EN and hepatitis B vaccine.1 A 2017…

  • Do Vaccines Cause Diabetes?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* do not cause diabetes. Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM) 1, now called the National Academy of Medicine (NAM), described a number of studies with sufficient validity and precision that all reported a lack of an association between…

  • Do Vaccines Cause Deltoid Bursitis? Shoulder Injury Related to Vaccination (SIRVA)

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    Conclusion Vaccines can cause shoulder injury related to vaccination (SIRVA), including deltoid bursitis, when administered incorrectly. The primary evidence supporting a causal association includes clinical assessment and imaging studies of the area where the injection occurred. Injection in the upper third of the deltoid can result in inflammation of the subacromial (deltoid) bursa, the supraspinatus…

  • Do Vaccines Cause Complex Regional Pain Syndrome?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause complex regional pain syndrome (CRPS). Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), found no relevant studies of quality in the literature assessing CRPS and vaccination1.…

  • Do Vaccines Cause Chronic Inflammatory Disseminated Polyneuropathy?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause chronic inflammatory disseminated polyneuropathy (CIDP). Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), found no relevant studies of quality in the literature assessing CIDP and MMR,…

  • Do Vaccines Cause Brachial Neuritis?

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    Conclusion Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause brachial neuritis. Epidemiological Evidence The 2012 report by the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), found no relevant studies of quality in the literature assessing an association between vaccination and brachial…

  • Do Vaccines Cause Asthma?

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    Conclusion Natural infection with respiratory syncytial virus (RSV) in infancy can increase the risk of asthma in childhood, as well as contribute to asthma exacerbation. Other respiratory viruses such as influenza can also contribute to asthma exacerbation. Thus, RSV vaccine prevents asthma and asthma exacerbation, and influenza vaccine prevents asthma exacerbation, by protecting against natural…

  • Do Vaccines Cause Arthralgia or Arthritis?

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    Conclusion Infections may trigger or contribute to the pathogenesis of arthritis. Thus, vaccines may prevent arthritis by protecting against natural infections. Rubella-containing vaccines (e.g. MMR) can cause mild, acute, transient arthralgia or arthritis, rarely in children but commonly in certain adult women (between 10-25% of adult female vaccinees without preexisting rubella immunity), usually beginning 1-3…

  • Do Vaccines Cause Acute Disseminated Encephalomyelitis (ADEM)?

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    Conclusion Older formulations of rabies vaccine did cause Acute Disseminated Encephalomyelitis (ADEM), but newer formulations of rabies vaccine have not been shown to cause ADEM, and rabies vaccine is not routinely recommended to the general population in the United States. Other vaccines that are currently routinely recommended to the general population in the U.S.* have…

  • Categories of Causality Conclusions*

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    To summarize the evidence regarding potential adverse events in an accurate, concise, practical and standardized manner, we established the categories of causality conclusions.