TY - JOUR
T1 - The state of vaccine safety science
T2 - systematic reviews of the evidence
AU - Dudley, Matthew Z.
AU - Halsey, Neal A.
AU - Omer, Saad B.
AU - Orenstein, Walter A.
AU - O'Leary, Sean T.
AU - Limaye, Rupali J.
AU - Salmon, Daniel A.
N1 - Funding Information:
This work was supported in part by the National Institutes of Health (grant number R01AI110482 ). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Funding Information:
MZD reports grants from Walgreens. NAH reports personal fees from Merck & Co, Pfizer, Valneva, Takeda, and ILiAD Biotechnologies, for advisory and safety board participation. DAS reports consulting fees or grants from Pfizer, Walgreens, and Merck & Co. All other authors declare no competing interests.
Publisher Copyright:
© 2020 Elsevier Ltd
PY - 2020/5
Y1 - 2020/5
N2 - This Review updates the scientific evidence assessing possible causal associations of adverse events following immunisation (AEFI) compiled in the 2012 report from the Institute of Medicine and the 2014 report from the Agency for Healthcare Research and Quality. For 12 of 46 AEFI examined, a causal relationship has been established with at least one vaccine currently routinely recommended to the general USA population: anaphylaxis, arthralgia or arthritis (mild, acute, and transient, not chronic), deltoid bursitis (when vaccine is administered improperly), disseminated varicella infection (in immune deficient individuals for whom the varicella vaccine is contraindicated), encephalitis, febrile seizures, Guillain-Barré syndrome, hepatitis (in immune deficient individuals for whom the varicella vaccine is contraindicated), herpes zoster, immune thrombocytopenic purpura, meningitis, and syncope. Other than mild acute and transient arthralgia or arthritis, which is very common in adult women after rubella vaccine, these adverse reactions are rare or very rare. Vaccines have an excellent safety profile overall and provide protection against infectious diseases to individuals and the general population.
AB - This Review updates the scientific evidence assessing possible causal associations of adverse events following immunisation (AEFI) compiled in the 2012 report from the Institute of Medicine and the 2014 report from the Agency for Healthcare Research and Quality. For 12 of 46 AEFI examined, a causal relationship has been established with at least one vaccine currently routinely recommended to the general USA population: anaphylaxis, arthralgia or arthritis (mild, acute, and transient, not chronic), deltoid bursitis (when vaccine is administered improperly), disseminated varicella infection (in immune deficient individuals for whom the varicella vaccine is contraindicated), encephalitis, febrile seizures, Guillain-Barré syndrome, hepatitis (in immune deficient individuals for whom the varicella vaccine is contraindicated), herpes zoster, immune thrombocytopenic purpura, meningitis, and syncope. Other than mild acute and transient arthralgia or arthritis, which is very common in adult women after rubella vaccine, these adverse reactions are rare or very rare. Vaccines have an excellent safety profile overall and provide protection against infectious diseases to individuals and the general population.
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U2 - 10.1016/S1473-3099(20)30130-4
DO - 10.1016/S1473-3099(20)30130-4
M3 - Review article
C2 - 32278359
AN - SCOPUS:85083776143
SN - 1473-3099
VL - 20
SP - e80-e89
JO - The Lancet Infectious Diseases
JF - The Lancet Infectious Diseases
IS - 5
ER -