Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection

Patone, Martina; Mei, Xue W.; Handunnetthi, Lahiru; Dixon, Sharon; Zaccardi, Francesco; Shankar-Hari, Manu; Watkinson, Peter; Khunti, Kamlesh; Harnden, Anthony; Coupland, Carol A.C.; Channon, Keith M.; Mills, Nicholas L.; Sheikh, Aziz; Hippisley-Cox, Julia

Abstract

Although myocarditis and pericarditis were not observed as adverse events in coronavirus disease 2019 (COVID-19) vaccine trials, there have been numerous reports of suspected cases following vaccination in the general population. We undertook a self-controlled case series study of people aged 16 or older vaccinated for COVID-19 in England between 1 December 2020 and 24 August 2021 to investigate hospital admission or death from myocarditis, pericarditis and cardiac arrhythmias in the 1–28 days following adenovirus (ChAdOx1, n = 20,615,911) or messenger RNA-based (BNT162b2, n = 16,993,389; mRNA-1273, n = 1,006,191) vaccines or a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (n = 3,028,867). We found increased risks of myocarditis associated with the first dose of ChAdOx1 and BNT162b2 vaccines and the first and second doses of the mRNA-1273 vaccine over the 1–28 days postvaccination period, and after a SARS-CoV-2 positive test. We estimated an extra two (95% confidence interval (CI) 0, 3), one (95% CI 0, 2) and six (95% CI 2, 8) myocarditis events per 1 million people vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, respectively, in the 28 days following a first dose and an extra ten (95% CI 7, 11) myocarditis events per 1 million vaccinated in the 28 days after a second dose of mRNA-1273. This compares with an extra 40 (95% CI 38, 41) myocarditis events per 1 million patients in the 28 days following a SARS-CoV-2 positive test. We also observed increased risks of pericarditis and cardiac arrhythmias following a positive SARS-CoV-2 test. Similar associations were not observed with any of the COVID-19 vaccines, apart from an increased risk of arrhythmia following a second dose of mRNA-1273. Subgroup analyses by age showed the increased risk of myocarditis associated with the two mRNA vaccines was present only in those younger than 40.

Citation

Patone, M., Mei, X. W., Handunnetthi, L., Dixon, S., Zaccardi, F., Shankar-Hari, M., Watkinson, P., Khunti, K., Harnden, A., Coupland, C. A., Channon, K. M., Mills, N. L., Sheikh, A., & Hippisley-Cox, J. (2022). Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nature Medicine, 28(2), 410-422. https://doi.org/10.1038/s41591-021-01630-0

• Journal Article Type: Article
• Acceptance Date: Nov 15, 2021
• Online Publication Date: Dec 14, 2021
• Publication Date: Feb 1, 2022
• Deposit Date: Dec 20, 2021
• Publicly Available Date: Dec 21, 2021
• Journal: Nature Medicine
• Print ISSN: 1078-8956
• Electronic ISSN: 1546-170X
• Publisher: Nature Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 28
• Issue: 2
• Pages: 410-422
• DOI: https://doi.org/10.1038/s41591-021-01630-0
• Keywords: General Biochemistry, Genetics and Molecular Biology; General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/7053364
• Publisher URL: https://www.nature.com/articles/s41591-021-01630-0