April 25, 2022
To summarize the evidence regarding potential adverse events in an accurate, concise, practical and standardized manner, we established the categories of causality conclusions.
Immunization schedules for children, preteens, teens, adults and travelers.
Vaccines are made with a variety of ingredients including antigens, stabilizers, adjuvants, and preservatives; they may also contain residual by-products from the production process. Knowing
3 COVID-19 vaccines are authorized in the United States: two messenger ribonucleic acid (mRNA) vaccines (Pfizer-BioNTech and Moderna) and one viral vector vaccine (J&J).
Advisory Committee on Immunization Practices (ACIP) Recommendations Infants and Children Adolescents and Adults For More Information Important Information for Obstetric Providers Disease Diphtheria disease is
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 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 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.
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.
Updated tables for Excipients (by Vaccine Name, Vaccine Type and Excipient Name) and Potential Allergens are now available.
Recommendations from the Advisory Committee on Immunization Practices (ACIP) Infants Children, Adolescents and Adults For More Information Important Information for Obstetric Providers Disease Haemophilus influenzae
Advisory Committee on Immunization Practices (ACIP) Recommendations Infants Children, Adolescents and Adults For More Information Important Information for Obstetric Providers Disease Hepatitis A Virus (HAV)
Advisory Committee on Immunization Practices (ACIP) Recommendations Infants Children and Adolescents Adults For More Information Important Information for Obstetric Providers Disease Hepatitis B Virus (HBV)
Conversations about vaccines with many patients can be easy. For some patients, vaccines can be a difficult topic. Talking with patients about uncomfortable topics can
Advisory Committee on Immunization Practices (ACIP) Recommendations Adolescents and Adults For More Information Important Information for Obstetric Providers Disease HPV is a small DNA virus
Advisory Committee on Immunization Practices (ACIP) Recommendations All Age Groups Infants and Children For More Information Important Information for Obstetric Providers Disease Influenza is caused
This site contains useful information on vaccines that are routinely recommended for most children, adolescents, adults and pregnant women in the United States. This information
IVS is a partner in the Global Vaccine Data Network™ and consortium creating Safety by Numbers, a newsletter supporting vaccine safety communication.
Advisory Committee on Immunization Practices (ACIP) Recommendations Infants and Children Adults All Age Groups For More Information Important Information for Obstetric Providers Disease Measles is
Advisory Committee on Immunization Practices (ACIP) Recommendations Adolescents All Age Groups For More Information Important Information for Obstetric Providers Disease Neisseria meningitidis, or meningococcus, is
Michelle Goryn, MA, IVS Senior Project Coordinator, provides programmatic support for a variety of projects for IVS. She has more than 20 years of experience
Safety standards for vaccines are very high given they are used among healthy persons for prevention rather than treatment and it is often difficult to
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Advisory Committee on Immunization Practices (ACIP) Recommendations Infants Children, Adolescents and Adults For More Information Important Information for Obstetric Providers Disease Streptococcus pneumoniae is a
Advisory Committee on Immunization Practices (ACIP) Recommendations Infants Children Adults For More Information Important Information for Obstetric Providers Disease Poliovirus is an RNA enterovirus of
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
Click Column title to sort [1] This product is not FDA-approved but was authorized for use under the Emergency Use Authorization on February 27, 2021. This
The practices and beliefs of various religious groups can seemingly be in conflict with some of the components of some vaccines. The information below touches on some of these topics and provides links to articles and webpages expanding on these issues.
Advisory Committee on Immunization Practices (ACIP) Recommendations Infants Children Adults For More Information Important Information for Obstetric Providers Disease Respiratory syncytial virus (RSV) is an
Recommendations from the Advisory Committee on Immunization Practices (ACIP) Infants For More Information Important Information for Obstetric Providers Disease Rotavirus is a very stable double-stranded
Information summaries are provided for each vaccine currently routinely recommended for children, adolescents, adults, and pregnant women in the United States, along with the diseases
It is law in all US states that children be properly immunized before attending school. However, in addition to medical exemptions offered in each state, the vast majority of states allow for religious exemptions and various states allow personal belief exemptions for daycare and school.
List of all National Academy of Medicine (formerly Institute of Medicine) safety reports.
Smallpox and yellow fever vaccinations should not be given to women who are currently breastfeeding. Both vaccine viruses have been transmitted to infants from breastfeeding
Below is a table summarizing the recommended use of vaccines during pregnancy in the U.S. Included in this table is information most relevant to women
Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS
Advisory Committee on Immunization Practices (ACIP) Recommendations Infants and Children Adolescents and Adults For More Information Important Information for Obstetric Providers Disease Varicella is a
Vaccine Information Statements: VISs are sheets developed by the US CDC that detail benefits and risks of a vaccine. Before a dose of vaccine is
There are four COVID-19 vaccines currently available (or previously) in the United States (US). Below we describe these vaccines and summarize the available data on
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