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Peer reviewedOpen accessCOVID-19

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021

JAMA·

Matthew E. Oster, David K. Shay, John R. Su, Julianne Gee, C. Buddy Creech, Karen R. Broder, Kathryn Edwards, Jonathan H. Soslow, Jeffrey M. Dendy, Elizabeth Schlaudecker, Sean M. Lang, Elizabeth D. Barnett, Frederick L. Ruberg, Michael J. Smith, M. Jay Campbell, Renato D. Lopes, Laurence S. Sperling, Jane A. Baumblatt, Deborah L. Thompson, Paige L. Marquez, Penelope Strid, Jared Woo, River Pugsley, Sarah Reagan-Steiner, Frank DeStefano, Tom T. Shimabukuro

DOI
10.1001/jama.2021.24110
PMID
35076665
PMCID
PMC8790664
OpenAlex
W4207051048
Study type
Journal article
Publisher
American Medical Association (AMA)
Article type
journal-article
Integrity
current

Why this research matters now

The authors note that the elevated myocarditis risk should be interpreted alongside the established benefits of COVID-19 vaccination, suggesting relevance for vaccine-safety communication and risk-benefit framing.

01

Structured evidence summary

Research question

The study examined the frequency, demographics, and clinical features of myocarditis reports following mRNA-based COVID-19 vaccination in the US.

Study design

Descriptive analysis of passive surveillance reports submitted to VAERS between December 2020 and August 2021, with adjudication of myocarditis reports and medical record review for a subset of cases.

Population and setting

Individuals older than 12 years in the US who received an mRNA-based COVID-19 vaccine (BNT162b2 or mRNA-1273), totaling over 192 million persons and more than 354 million vaccine doses.

Main findings

Among 1,626 myocarditis cases meeting the case definition, median age was 21 years and 82% occurred in males; observed reporting rates within 7 days of vaccination exceeded expected background rates across several age and sex strata. Highest rates followed the second dose in adolescent males aged 12-15 (70.7 per million BNT162b2 doses), 16-17 years (105.9 per million BNT162b2 doses), and young men aged 18-24 (52.4 and 56.3 per million BNT162b2 and mRNA-1273 doses, respectively). Among cases under 30 years with clinical detail, elevated troponin was common, most were hospitalized, and a majority had symptom resolution by discharge.

Public-health relevance

The authors note that the elevated myocarditis risk should be interpreted alongside the established benefits of COVID-19 vaccination, suggesting relevance for vaccine-safety communication and risk-benefit framing.

Important limitations

This summary is limited to the supplied single-article abstract and metadata; the original paper is required for decision-grade interpretation, including appraisal of VAERS-based passive surveillance (e.g., under- or differential reporting, lack of a non-vaccinated comparison group, and inability to establish causality).

GIDS interpretation

The publication is indexed in bibliographic databases under topics including vaccination, surveillance, and vaccine safety, which may aid discoverability for reviewers screening for post-authorization myocarditis signals.

02

Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

03

Evidence relationships

This article has 15 auditable classifier relationships to diseases, places, topics, and study design.

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