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Myocarditis and pericarditis in association with COVID-19 mRNA-vaccination: cases from a regional pharmacovigilance
Ioanna Istampoulouoglou1, Georgios Dimitriou2, Selina Späni3
1Department of Clinical Pharmacology & Toxicology, University Hospital and University of Basel, Switzerland.
Abstract:
In this article we summarize suspected adverse events following immunization (AEFI) of pericarditis, myocarditis and perimyocarditis that were reported by our regional pharmacovigilance centre after COVID-19 mRNA-vaccination and discuss their association with these vaccines. Seventeen cases were reported between March and July 2021. Of these, nine had perimyocarditis, five myocarditis and three pericarditis. Twelve patients were male (71%). The median age was 38 years (range 17-88). The most commonly observed presenting symptom was acute chest pain (65%). While 47% of the patients were previously healthy, 53% had at least one pre-existing comorbidity, with hypertension being the most prevalent (24%). The European Society of Cardiology diagnostic criteria for the reported AEFIs were fulfilled in twelve cases (71%). The AEFIs occurred after the first vaccine dose in six cases (35%), after the second vaccine dose in ten cases (59%) and after both doses in one case (6%). The median latency of all AEFIs taken together was 14 days (range 1-28) after the first vaccination and 3 days (range 1-17) after the second one. All patients except one were hospitalized (94%) with a median length of stay of 7.5 days (range 3-13). The majority of patients (n = 11, 65%) did not experience any complications, and 13 (77%) of the patients had recovered or were recovering at the time of discharge. In 16 of the 17 cases (94%), the association between the AEFI and mRNA-vaccination was considered possible by the pharmacovigilance centre.
Insights
Adverse events following immunization (AEFI) including myocarditis, pericarditis, and perimyocarditis were reported after COVID-19 mRNA vaccination. Most cases were linked to the second vaccine dose and resolved with hospitalization, suggesting a possible association.
Area of Science:
- Cardiology
- Immunology
- Public Health
Background:
- Adverse events following immunization (AEFI) are monitored to ensure vaccine safety.
- Myocarditis, pericarditis, and perimyocarditis are potential cardiac complications.
- COVID-19 mRNA vaccines have been widely administered globally.
Purpose of the Study:
- To summarize and analyze suspected cases of pericarditis, myocarditis, and perimyocarditis following COVID-19 mRNA vaccination.
- To discuss the potential association between these cardiac AEFIs and mRNA vaccination.
Main Methods:
- Retrospective analysis of suspected AEFI cases reported to a regional pharmacovigilance center.
- Inclusion of cases of pericarditis, myocarditis, and perimyocarditis occurring after COVID-19 mRNA vaccination between March and July 2021.
- Assessment of clinical presentation, comorbidities, diagnostic criteria fulfillment, vaccination timing, latency, hospitalization, and outcomes.
Main Results:
- Seventeen cases of pericarditis, myocarditis, or perimyocarditis were reported.
- The majority of affected patients were male, with a median age of 38 years.
- Acute chest pain was the most common symptom; 53% had pre-existing comorbidities.
- AEFIs predominantly occurred after the second vaccine dose with a median latency of 3 days.
- Most patients were hospitalized and recovered or were recovering at discharge.
- A possible association with mRNA vaccination was considered in 94% of cases.
Conclusions:
- Suspected cases of pericarditis, myocarditis, and perimyocarditis following COVID-19 mRNA vaccination were reported.
- The majority of cases showed a possible association with mRNA vaccination and had favorable outcomes.
- Continued pharmacovigilance is crucial for monitoring vaccine safety and understanding rare adverse events.
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