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Oxford University Press - PMC COVID-19 Collection logoLink to Oxford University Press - PMC COVID-19 Collection
. 2021 Dec 27:jiab628. doi: 10.1093/infdis/jiab628

Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring

Winston E Abara 1,, Julianne Gee 1,, Mark Delorey 1, Ye Tun 1, Yi Mu 1, David K Shay 1, Tom Shimabukuro 1
PMCID: PMC8755334  PMID: 34958099

Abstract

Using meta-analytic methods, we calculated expected rates of 21 potential adverse events of special interest (AESI) that would occur following COVID-19 vaccination within 1-, 7-, and 42-day intervals without causal associations. Based on these expected rates, if 10,000,000 persons are vaccinated, 0.5, 3.7, and 22.5 Guillain-Barre syndrome cases; 0.3, 2.4, and 14.3 myopericarditis cases; and 236.5, 1655.5, and 9932.8 all-cause deaths would occur coincidentally within 1, 7, and 42 days post-vaccination, respectively. Expected rates of potential AESI can contextualize events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine health communications, and inform COVID-19 vaccine benefit-risk assessments.

Keywords: Background rates, Expected rates, Adverse events, COVID-19, Vaccination, Vaccine safety, Vaccine surveillance, Vaccine benefit-risk assessment

Supplementary Material

jiab628_suppl_Supplementary_Material

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

jiab628_suppl_Supplementary_Material

Articles from The Journal of Infectious Diseases are provided here courtesy of Oxford University Press

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