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

Abstract

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.