Comparative Analysis of Adverse Drug Reactions (ADRs) between COVID-19 Vaccines and Established Vaccines: A CDC VAERS Database Analysis

Background: COVID-19 vaccines have been developed rapidly to combat the pandemic, but vaccine hesitancy remains a challenge due to concerns about adverse drug reactions (ADRs). This study aimed to compare the ADR profiles of COVID-19 vaccines with established vaccines and investigate differences between adults and children. Methods: A retrospective observational study used the VAERS database to analyze ADR reports from January 2021 to December 2022 in the United States. Top ten common ADRs and seven severe ADRs associated with COVID-19 vaccines were studied using the Evans Criteria. Results: Among the common ADRs, only dyspnea showed disproportionate reporting in COVID-19 vaccines. Severe ADRs, including myocarditis, pneumonia, and cerebrovascular accidents, were disproportionately reported. Age-stratified analysis revealed myocarditis disproportionately reported in both adults and children. Conclusions: This study provides a comprehensive comparison of ADRs between COVID-19 vaccines and established vaccines. Although some severe ADRs were disproportionately reported, further evaluation is required to establish any causal relationships with COVID-19 vaccine. Continuous monitoring of ADRs is crucial for vaccine safety.