Evidence map›Paper›PMID 42828645›Full record

ArticleDrug safety2026

Safety Monitoring of COVID-19 Vaccines in the Vaccine Adverse Event Reporting System (VAERS): United States, August 22, 2024-July 4, 2025.

Brittney Romanson, Pedro L Moro, Penelope Strid, Anne Hause, Erin Stroud, Paige L Marquez, Bicheng Zhang, Carol Ennulat, Hannah Brown, John R Su

Abstract read
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In one paragraph

Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Brittney RomansonDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
Pedro L MoroDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA. psm9@cdc.gov.
Penelope StridDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
Anne HauseDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
Erin StroudDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
Paige L MarquezDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
Bicheng ZhangDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
Carol EnnulatDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
Hannah BrownDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.
John R SuDivision of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), Immunization Safety Office, 1600 Clifton Rd, MS H16-3, Atlanta, GA, 30329-4027, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

objectivesThe 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.

methodsWe 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.

resultsVAERS 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.

conclusionThis 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.

Identifiers

PMID42828645

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.