Myocarditis and pericarditis associated with SARS-CoV-2 vaccines: A population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countries

Sophie H. Bots, Judit Riera-Arnau, Svetlana V. Belitser, Davide Messina, Maria Aragón, Ema Alsina, Ian J. Douglas, Carlos E. Durán, Patricia García-Poza, Rosa Gini, Ron M. C. Herings, Consuelo Huerta, Malede Mequanent Sisay, Mar Martín-Pérez, Ivonne Martin, Jetty A. Overbeek, Olga Paoletti, Meritxell Pallejà-Millán, Anna Schultze, Patrick SouvereinKarin M. A. Swart, Felipe Villalobos, Olaf H. Klungel, Miriam C. J. M. Sturkenboom

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Background: Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity of events, especially in age- and sex-stratified analyses. Methods: Population-based cohort study with nested self-controlled risk interval (SCRI) using healthcare data from five European databases. Individuals were followed from 01/01/2020 until end of data availability (31/12/2021 latest). Outcome was first myo-/pericarditis diagnosis. Exposures were first and second dose of Pfizer, AstraZeneca, Moderna, and Janssen COVID-19 vaccines. Baseline incidence rates (IRs), and vaccine- and dose-specific IRs and rate differences were calculated from the cohort The SCRI calculated calendar time-adjusted IR ratios (IRR), using a 60-day pre-vaccination control period and dose-specific 28-day risk windows. IRRs were pooled using random effects meta-analysis. Findings: Over 35 million individuals (49·2% women, median age 39–49 years) were included, of which 57·4% received at least one COVID-19 vaccine dose. Baseline incidence of myocarditis was low. Myocarditis IRRs were elevated after vaccination in those aged < 30 years, after both Pfizer vaccine doses (IRR = 3·3, 95%CI 1·2-9.4; 7·8, 95%CI 2·6-23·5, respectively) and Moderna vaccine dose 2 (IRR = 6·1, 95%CI 1·1-33·5). An effect of AstraZeneca vaccine dose 2 could not be excluded (IRR = 2·42, 95%CI 0·96-6·07). Pericarditis was not associated with vaccination. Interpretation: mRNA-based COVID-19 vaccines and potentially AstraZeneca are associated with increased myocarditis risk in younger individuals, although absolute incidence remains low. More data on children (≤ 11 years) are needed.

Original languageEnglish
Article number1038043
JournalFrontiers in Pharmacology
Publication statusPublished - 24 Nov 2022


  • COVID-19 vaccine
  • adverse drug reaction
  • myocarditis
  • pericarditis
  • pharmacovigilance

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