Reporting Rates for VAERS Death Reports Following COVID-19 Vaccination, December 14, 2020-November 17, 2021

  1. Brendan Day
  2. David Menschik
  3. Deborah Thompson
  4. Christopher Jankosky
  5. John Su
  6. Pedro Moro
  7. Craig Zinderman
  8. Kerry Welsh
  9. Narayan Nair
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Abstract

Background

Despite 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).

Objective

To provide information and context about reports of death to VAERS following COVID-19 vaccination.

Design

Descriptive study; reporting rates for VAERS death reports.

Setting

United States; December 14, 2020, to November 17, 2021.

Participants

COVID-19 vaccine recipients.

Measurements

Reporting rates for death events per million persons vaccinated; adverse event counts; data mining signals of disproportionate reporting.

Results

9,201 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.

Limitations

VAERS 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.

Conclusion

Reporting 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 Source

No external sources of funding were used.

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