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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.
  • Patone M; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Mei XW; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Handunnetthi L; Wellcome Centre for Human Genetics, University of Oxford, Oxford, UK.
  • Dixon S; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Zaccardi F; Leicester Real World Evidence Unit, Diabetes Research Centre, University of Leicester, Leicester, UK.
  • Shankar-Hari M; Usher Institute, University of Edinburgh, Edinburgh, UK.
  • Watkinson P; Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK.
  • Khunti K; School of Immunology and Microbial Sciences, King's College London, London, UK.
  • Harnden A; Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
  • Coupland CAC; NIHR Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.
  • Channon KM; Leicester Real World Evidence Unit, Diabetes Research Centre, University of Leicester, Leicester, UK.
  • Mills NL; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Sheikh A; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Hippisley-Cox J; Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK.
Nat Med ; 28(2): 410-422, 2022 02.
Article in English | MEDLINE | ID: covidwho-1575259
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pericarditis / Arrhythmias, Cardiac / BNT162 Vaccine / 2019-nCoV Vaccine mRNA-1273 / ChAdOx1 nCoV-19 / Myocarditis Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Adolescent / Adult / Female / Humans / Male / Young adult Country/Region as subject: Europa Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2022 Document Type: Article Affiliation country: S41591-021-01630-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pericarditis / Arrhythmias, Cardiac / BNT162 Vaccine / 2019-nCoV Vaccine mRNA-1273 / ChAdOx1 nCoV-19 / Myocarditis Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Adolescent / Adult / Female / Humans / Male / Young adult Country/Region as subject: Europa Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2022 Document Type: Article Affiliation country: S41591-021-01630-0