Reactogenicity to COVID-19 vaccination in the United States of America.

PURPOSE

In the United States, Pfizer-BioNTech, Moderna, and Janssen's coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. The purpose of this study is to analyze passive surveillance data on COVID-19 vaccine adverse reaction in the United States.

MATERIALS AND METHODS

We analyzed passive surveillance data on COVID-19 vaccine adverse reactions which were retrieved from the Vaccine Adverse Event Reporting System database. Retrieved records on demographic information as well as the top 10 common vaccine adverse events were extracted and assessed from 200 of the most recently reported cases for the study analysis.

RESULTS

Local and systemic adverse reactions were reported in the study. A significant difference (p<0.05) was recorded for the top 10 systemic reactions by age category (0.041) and by gender (0.002). Analysis of the top five systemic reactions, stratified by vaccine type yielded a significant difference (p<0.05) for chills (p=0.044), and when stratified by age group and type of vaccination received, it yielded a significant difference (p<0.05) for fatigue (p=0.023). Overall, Pfizer had 182 persons (91.0%) reporting adverse events, Moderna with 13 (6.5%), and Janssen with 5 (2.5%).

CONCLUSION

Mild side effects were reported following vaccination with the EUA COVID-19 vaccines in the United States. Thus, continuous monitoring and reporting of all adverse events are recommended to ensure the safety of vaccination.