Observational studyClinical pharmacology and therapeutics2022
Features of Inflammatory Heart Reactions Following mRNA COVID-19 Vaccination at a Global Level.
Observational study in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 4 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Takotsubo syndrome and vaccines: a systematic review.ESC heart failure · 2024Pooled it
- COVID-19 vaccine induced myocarditis in young males: A systematic review.European journal of clinical investigation · 2023Pooled it
- COVID-19 vaccination and carditis in children and adolescents: a systematic review and meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2022Pooled it
- Pooled it
- Myocardial and Vascular Involvement in COVID-19 and Post-Vaccination States: Understanding Injury Pathways and Clinical Implications.Life (Basel, Switzerland) · 2026Review
- Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database.Drug safety · 2025Article
- Adverse Events Following COVID-19 Vaccination in Adolescents: Insights From Pharmacovigilance Study of VigiBase.Journal of Korean medical science · 2024Article
- Review
- Myocarditis in SARS-CoV-2: A Meta-Analysis.Cureus · 2023Review
- Systematic review and meta-analysis of myocarditis and pericarditis in adolescents following COVID-19 BNT162b2 vaccination.NPJ vaccines · 2023Review
- Two pediatric cases of multisystem inflammatory-like syndrome following COVID-19 vaccination.Archives de pediatrie : organe officiel de la Societe francaise de pediatrie · 2022Article
- CMR Manifestations, Influencing Factors and Molecular Mechanism of Myocarditis Induced by COVID-19 Mrna Vaccine.Reviews in cardiovascular medicine · 2022Review
- Myopericarditis in a Male Adolescent Following the Second Shot of COVID-19 Pfizer m-RNA Vaccine: Typical Example and Analysis of 110 Single Case Reports.Pediatric reports · 2022Review
- Review
- Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review.BMJ (Clinical research ed.) · 2022Review
- COVID-19 vaccination and cardiac dysfunction.World journal of cardiology · 2022Review
- Adverse Events and Safety Profile of the COVID-19 Vaccines in Adolescents: Safety Monitoring for Adverse Events Using Real-World Data.Vaccines · 2022Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
Myocarditis and pericarditis may constitute adverse reactions of mRNA coronavirus disease 2019 (COVID-19) vaccines. This study aimed to document these reactions and to assess the association with patient sex and age. This is as an observational retrospective study using a case-non-case design (also called disproportionality study) on inflammatory heart reactions reported with mRNA COVID-19 vaccines within the World Health Organization (WHO) global safety database (VigiBase), up to June 30, 2021. Results are expressed using reporting odds ratios (RORs) and their 95% confidence interval (95% CI). Of 716,576 reports related to mRNA COVID-19 vaccines, 2,277 were cases of inflammatory heart reactions, including 1241 (55%) myocarditis and 851 (37%) pericarditis. The main age group was 18-29 years (704, 31%), and mostly male patients (1,555, 68%). Pericarditis onset was delayed compared with myocarditis with a median time to onset of 8 (3-21) vs. 3 (2-6) days, respectively (P = 0.001). Regarding myocarditis, an important disproportionate reporting was observed in adolescents (ROR, 22.3, 95% CI 19.2-25.9) and in 18-29 years old (ROR, 6.6, 95% CI 5.9-7.5) compared with older patients, as well as in male patients (ROR, 9.4, 95% CI 8.3-10.6). Reporting rate of myocarditis was increased in young adults and adolescents. Inflammatory heart reactions may rarely occur shortly following mRNA COVID-19 vaccination. Although an important disproportionate reporting of myocarditis was observed among adolescents and young adults, particularly in male patients, reporting rates support a very rare risk, that does not seem to compromise the largely positive benefit-risk balance of these vaccines. Furthermore, this study confirmed the value of disproportionality analyses for estimation of relative risks among subgroups of patients.
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