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.

January 25, 2022 – Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021 | Cardiology | JAMA | JAMA Network

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

Key Points

Question  What is the risk of myocarditis after mRNA-based COVID-19 vaccination in the US?

Findings  In this descriptive study of 1626 cases of myocarditis in a national passive reporting system, the crude reporting rates within 7 days after vaccination exceeded the expected rates across multiple age and sex strata. The rates of myocarditis cases 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).

Meaning  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.Abstract

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.

Matthew E. Oster, MD, MPH^1,2,3; David K. Shay, MD, MPH¹; John R. Su, MD, PhD, MPH¹; et alJulianne Gee, MPH¹; C. Buddy Creech, MD, MPH⁴; Karen R. Broder, MD¹; Kathryn Edwards, MD⁴; Jonathan H. Soslow, MD, MSCI⁴; Jeffrey M. Dendy, MD⁴; Elizabeth Schlaudecker, MD, MPH⁵; Sean M. Lang, MD⁵; Elizabeth D. Barnett, MD⁶; Frederick L. Ruberg, MD⁶; Michael J. Smith, MD, MSCE⁷; M. Jay Campbell, MD, MHA⁷; Renato D. Lopes, MD, PhD, MHS⁷; Laurence S. Sperling, MD^1,2; Jane A. Baumblatt, MD⁸; Deborah L. Thompson, MD, MSPH⁸; Paige L. Marquez, MSPH¹; Penelope Strid, MPH¹; Jared Woo, MPH¹; River Pugsley, PhD, MPH¹; Sarah Reagan-Steiner, MD, MPH¹; Frank DeStefano, MD, MPH¹; Tom T. Shimabukuro, MD, MPH, MBA¹Author AffiliationsArticle InformationJAMA. 2022;327(4):331-340. doi:10.1001/jama.2021.24110related articles icon RelatedArticles

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