Healthcare providers are required to report to VAERS the following adverse events after COVID-19 vaccination [under Emergency Use Authorization (EUA)], and other adverse events if later revised by FDA:
Vaccine administration errors, whether or not associated with an adverse event (AE)
Serious AEs regardless of causality. Serious AEs per FDA are defined as:
Death
A life-threatening AE
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
Cases of COVID-19 that result in hospitalization or death