COVID-19 Vaccine (Pfizer) and VAERS

While this vaccine is under Emergency Use Authorization (EUA), healthcare professionals are required to report 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 adults or children
  • Cases of COVID-19 that result in hospitalization or death 
  • Any additional AEs and revised safety reporting requirements per the Food and Drug Administration’s conditions for use of an authorized vaccine throughout the duration of the EUA 

Healthcare professionals are encouraged to report to VAERS:  

  • Clinically important adverse events that occur after vaccination, even if you are not sure whether the vaccine caused the adverse event  

Information on preventing, reporting, and managing mRNA COVID-19 vaccine administration errors is found in Appendix A of mRNA COVID-19 vaccine clinical considerations. Vaccine administration errors should be reported to the Vaccine Adverse Event Reporting System (VAERS).

 

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Page last reviewed: November 16, 2021