COVID-19 Vaccines and VAERS

For COVID-19 vaccines given under an EUA*, health care 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

*COVID-19 vaccines under an EUA: Pfizer-BioNTech for ages 6 months through 11 years, Moderna for ages 6 months through 11 years, Novavax for ages 12 years and older