Reporting to the Vaccine Adverse Event Reporting System (VAERS)
Healthcare providers are required to report the following to VAERS:
- Vaccine administration errors (whether associated with an adverse event [AE] or not)
- Serious AEs (irrespective of attribution to vaccination)
- Multisystem inflammatory syndrome (MIS) in children (if vaccine is authorized for use in children) or adults
- Cases of COVID-19 that result in hospitalization or death after the recipient has received COVID-19 vaccine
Healthcare providers are also encouraged to report any clinically significant AEs that occur after vaccine administration.
Adverse events should be reported even if the cause of the AE is uncertain.
Healthcare providers should report any additional AEs and adhere to any revised safety reporting requirements per the FDA conditions of authorized vaccine use posted on FDA’s website throughout the duration of the EUA.