Abstract
Background
The 2024-2025 formulation for all Coronavirus Disease 2019 (COVID-19) vaccines licensed or authorized in the United States (US) was updated to a monovalent vaccine based on the Omicron JN.1 lineage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Post-authorization and post-approval safety monitoring is important to ensure ongoing vaccine safety.Objectives
The aim of this study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) among persons who received the 2024-2025 formulation of the COVID-19 vaccines in the US.Methods
We searched VAERS for US reports of individuals who received a COVID-19 vaccination and submitted a report during August 22, 2024, through July 4, 2025. Centers for Disease Control and Prevention (CDC) clinicians reviewed reports and available medical records for selected adverse events of special interest (AESIs) and serious reports. For reports of death, the reported cause of death was based on the International Classification of Disease, Tenth Revision (ICD-10) diagnostic categories reported on U.S. death certificates. For reports of anaphylaxis and Guillain-Barre syndrome (GBS), the Brighton Collaboration case definitions were used. For myocarditis, CDC's case definition was used. Reporting rates for the AESIs, excluding death, were estimated using vaccination coverage data for the 2024-2025 respiratory season.Results
VAERS received 9856 reports after 2024-2025 COVID-19 vaccination; 877 were serious (8.9%). The most common reported adverse events (AEs) included fever (854, 8.7%), pain (810, 8.2%), fatigue (785, 8.0%), headache (729, 7.4%), and dizziness (689, 7.0%). Of 273 deaths, cause of death was available for 97 reports, and the most common causes were diseases of the circulatory system (37, 38.1%), followed by diseases of the respiratory system (15, 15.5%). During the review period, no reports met the case definition of anaphylaxis, while eight reports met the Brighton case definition for GBS, and six reports met the case definition for myocarditis or myopericarditis. Death was not reported among the six myopericarditis cases. Reporting rates for GBS and myopericarditis were below background rates for these conditions.Conclusion
This review of AEs reported after the 2024-2025 formulation of the COVID-19 vaccines is consistent with previous observations after COVID-19 vaccination. Most reports were non-serious, and the most common AEs were consistent with known reactogenicity profiles. Ongoing safety monitoring of COVID-19 vaccines continues. Any potential risks of vaccine-related AEs should be considered in the context of the benefits of COVID-19 vaccines in preventing COVID-19 and its potentially serious complications.