On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine, administered as two doses separated by 21 days. Notifications and reports of suspected severe allergic reactions and anaphylaxis following vaccination were captured in the Vaccine Adverse Event Reporting System (VAERS), the national passive surveillance (spontaneous reporting) system for adverse events after immunization.
During December 14-23, 2020, after administration of a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine, the CDC identified 21 case reports submitted to VAERS that met Brighton Collaboration case definition criteria for anaphylaxis, corresponding to an estimated rate of 11.1 cases per million doses administered.
Patients experiencing anaphylaxis should be transported to facilities to receive appropriate medical care. All patients should be instructed to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination location. Clinicians have an important role in vaccine safety monitoring by being vigilant in recognizing and reporting adverse events to VAERS. Remember, don’t cut corners and ensure a minimum of 15 minutes observation post-vaccination, extended to 30 minutes if a patient has a history of allergies. Be safe, do the right thing, and follow the rules; it will pay in the end!
Stay the course, stay well, mask up, get vaccinated, and stay tuned!