Categories of Causality Conclusions*
To summarize the evidence regarding potential adverse events in an accurate, concise, practical and standardized manner, we established the categories of causality conclusions.
September 28, 2022
To summarize the evidence regarding potential adverse events in an accurate, concise, practical and standardized manner, we established the categories of causality conclusions.
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
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)
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,
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)
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.
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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.*
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
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
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
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,
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,
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
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
Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause OMS.
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
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.
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,
Vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause serum sickness.
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
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
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
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
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
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
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
Vaccines currently routinely recommended to the general population in the U.S have not been shown to cause vasculitis or PAN.
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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
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