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

Publication ,  Journal Article
Oster, ME; Shay, DK; Su, JR; Gee, J; Creech, CB; Broder, KR; Edwards, K; Soslow, JH; Dendy, JM; Schlaudecker, E; Lang, SM; Barnett, ED ...
Published in: JAMA
January 25, 2022

IMPORTANCE: Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear. OBJECTIVE: To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US. DESIGN, SETTING, AND PARTICIPANTS: Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021. EXPOSURES: Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna). MAIN OUTCOMES AND MEASURES: Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes. RESULTS: Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%). CONCLUSIONS AND RELEVANCE: Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.

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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 25, 2022

Volume

327

Issue

4

Start / End Page

331 / 340

Location

United States

Related Subject Headings

  • Young Adult
  • United States
  • Sex Distribution
  • Risk Factors
  • Myocarditis
  • Male
  • Immunization, Secondary
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

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Chicago
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MLA
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Oster, M. E., Shay, D. K., Su, J. R., Gee, J., Creech, C. B., Broder, K. R., … Shimabukuro, T. T. (2022). Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA, 327(4), 331–340. https://doi.org/10.1001/jama.2021.24110
Oster, Matthew E., David K. Shay, John R. Su, Julianne Gee, C Buddy Creech, Karen R. Broder, Kathryn Edwards, et al. “Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021.JAMA 327, no. 4 (January 25, 2022): 331–40. https://doi.org/10.1001/jama.2021.24110.
Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331–40.
Oster, Matthew E., et al. “Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021.JAMA, vol. 327, no. 4, Jan. 2022, pp. 331–40. Pubmed, doi:10.1001/jama.2021.24110.
Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, Edwards K, Soslow JH, Dendy JM, Schlaudecker E, Lang SM, Barnett ED, Ruberg FL, Smith MJ, Campbell MJ, Lopes RD, Sperling LS, Baumblatt JA, Thompson DL, Marquez PL, Strid P, Woo J, Pugsley R, Reagan-Steiner S, DeStefano F, Shimabukuro TT. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331–340.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

January 25, 2022

Volume

327

Issue

4

Start / End Page

331 / 340

Location

United States

Related Subject Headings

  • Young Adult
  • United States
  • Sex Distribution
  • Risk Factors
  • Myocarditis
  • Male
  • Immunization, Secondary
  • Humans
  • General & Internal Medicine
  • Female