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Licensed COVID-19 vaccines

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

Authorized COVID-19 vaccines

For COVID-19 vaccines given under an Emergency Use Authorization (EUA), vaccination providers are required to report to :

• Vaccine administration errors, whether or not associated with an adverse event
• Serious adverse events regardless of causality. Serious adverse events per the Food and Drug Administration (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.

Adverse event reporting procedures

• Information on how to submit a report to VAERS is available at or by calling 1-800-822-7967.
• Anyone can register in V-safe after their COVID-19 vaccination to receive health check-ins via text messages or email.