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CDC VAERS Reporting Requirement

The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use (EUA) or approved under Biologics License Application (BLA). Healthcare providers who administer COVID-19 vaccines are required to report the following to VAERS:

Vaccine administration errors, whether or not associated with an adverse event (AE):
1) If the incorrect mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series, VAERS reporting is required.

2) If a different product from the primary series is inadvertently administered for the additional or booster (third dose), VAERS reporting is required.

VAERS reporting is not required for the following situations:
If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient)
Mixing and matching of booster doses (as of October 21, 2021, mixing and matching of booster doses is allowed)

CDC COVID-19 Vaccination Program Provider Agreement (See #10)

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