The safety profile of COVID-19 vaccinations in the United States

Abstract

Background/aim: Pfizer-BioNTech, Moderna, and Johnson & Johnson's Janssen are the 3 COVID-19 vaccines authorized for emergency use in the United States. This study aims to analyze and compare adverse events following immunization associated with these COVID-19 vaccines based on Vaccine Adverse Effect Reporting System data.

Methods: We utilized Vaccine Adverse Effect Reporting System data from January 1, 2021 to April 30, 2021 to analyze and characterize adverse effects postvaccination with these authorized COVID-19 vaccines in the US population.

Results: A total of 141,208 individuals suffered at least one adverse events following immunization following 239.97 million doses of COVID-19 vaccination. The frequency of side effects was 0.04%, 0.06%, and 0.35% following administration of Pfizer-BioNTech, Moderna, and Johnson & Johnson's Janssen vaccines, respectively. Most of the patients had mild systemic side effects, the most common being headache (0.01%) and fever (0.01%). The frequency of serious side effects including anaphylaxis (0.0003%) and death (0.002%) was extremely low.

Conclusions: The three COVID 19 vaccines have a wide safety profile with only minor and self-limiting adverse effects. However, continued monitoring and surveillance is required to review any unexpected serious adverse effects.

Keywords: AEFIs; COVID-19; COVID-19 vaccine side effects; Covid-19 vaccine; vaers.