ABSTRACT
BackgroundDespite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). ObjectiveTo provide information and context about reports of death to VAERS following COVID-19 vaccination. DesignDescriptive study; reporting rates for VAERS death reports. SettingUnited States; December 14, 2020, to November 17, 2021. ParticipantsCOVID-19 vaccine recipients. MeasurementsReporting rates for death events per million persons vaccinated; adverse event counts; data mining signals of disproportionate reporting. Results9,201 death events were reported for COVID-19 vaccine recipients aged five years and older (or age unknown). Reporting rates for death events increased with increasing age, and males generally had higher reporting rates than females. For death events within seven days and 42 days of vaccination, respectively, observed reporting rates were lower than the expected all-cause death rates. Reporting rates for Ad26.COV2.S vaccine were generally higher than for mRNA COVID-19 vaccines, but still lower than the expected all-cause death rates. Reported adverse events were non-specific or reflected the known leading causes of death. LimitationsVAERS data are subject to several limitations such as reporting bias (underreporting and stimulated reporting), missing or inaccurate information, and lack of a control group. Reported diagnoses, including deaths, are not causally verified diagnoses. ConclusionReporting rates for death events were lower than the expected all-cause mortality rates. Trends in reporting rates reflected known trends in background mortality rates. These findings do not suggest an association between vaccination and overall increased mortality. Funding SourceNo external sources of funding were used.
