• COVID-19
  • Vaccine Safety

What kinds of adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS)?

The following guidance is taken directly from the CDC: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#adverse-events.

For licensed COVID-19 vaccines (Moderna and Pfizer-BioNTech in people ages 12 years and older), healthcare providers are strongly encouraged to report to VAERS:

  • Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event
  • Vaccine administration errors, whether or not associated with an adverse event

For COVID-19 vaccines given under an EUA, vaccination providers are required to report to VAERS:

  • Vaccine administration errors, whether or not associated with an adverse event
  • Serious adverse events regardless of causality. Serious adverse events per FDA are defined as:
    • Death
    • A life-threatening adverse event
    • Inpatient hospitalization or prolongation of existing hospitalization
    • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    • A congenital anomaly/birth defect
    • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
  • Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults
  • Cases of myocarditis
  • Cases of pericarditis
  • Cases of COVID-19 that result in hospitalization or death

Reporting is also encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov or by calling 1-800-822-7967.

Last reviewed: March 19, 2024

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