Myocarditis and pericarditis in association with COVID-19 mRNA-vaccination: cases from a regional pharmacovigilance centre

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 were recovered or 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.

Epidemiology, clinical ramifications, and cellular pathogenesis of COVID-19 mRNA-vaccination-induced adverse cardiovascular outcomes: A state-of-the-heart review

“…Study cohort characteristics, comorbidities, clinical presentation, diagnostic evaluation, and outcome are all summarized. Case Series Myocarditis Following COVID-19 mRNA Vaccine: A Case Series and Incidence Rate Determination Acute myocardial infarction and myocarditis following COVID-19 vaccination Myocarditis and pericarditis in association with COVID-19 mRNA-vaccination: cases from a regional pharmacovigilance center Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination Myocarditis and Pericarditis After Vaccination for COVID-19 Case Report Acute Myocarditis after COVID-19 vaccination: A case report Study Perez et al [7] Aye et al [9] Istampoulouoglou et al [24] Montgomery et al [25] Kim et al [26] Diaz et al [27] Study Schmitt et al [31] Characteristics Characteristics Cases, n 7 42 5 23 4 20 Case, n 1 Male, % 6 (86%) 38 (91%) 3 (60%) 23 (100%) 3 (75%) 15 (75%) Gender Male Medianage (range), years 44 (22–71) 21 (17–30) 34 ( 20–44) 25 (20–51) 38.3 (23–70) 36 (26.3–48.3) Age 19 Vaccine type Pfizer-BioNTech: 3 (42%) Moderna: 4 (57%) Pfizer BioNTech: 35 (83%) Moderna: 6 (14%) Moderna: 4 (80%) Comirnaty: 1 (20%) Pfizer BioNTech: 7 (30%) Moderna: 16 (70%) Pfizer BioNTech: 2 (50%) Moderna: 2 (50%) Pfizer BioNTech: 9 (45%) Moderna: 11 (55%) Vaccine type Second dose of Pfizer-BioNTech Comorbidities …”

“…Other studies that have reported myocarditis symptoms occurring post-second dose of COVID-19 mRNA vaccines reported rates hovering between 40% and 100%. Among the included studies, the median time between vaccination and onset of symptoms was 1–3 days [24] . However, one study reported a mean time of onset of 15.4 days, with a range of 3–28 days [24] .…”

“…Among the included studies, the median time between vaccination and onset of symptoms was 1–3 days [24] . However, one study reported a mean time of onset of 15.4 days, with a range of 3–28 days [24] . The study included case reports from Switzerland using the Regional Pharmacovigilance Center (RPVC) internal database for cases of myocarditis, perimyocarditis, and pericarditis temporally related to COVID-19 mRNA vaccination [24] .…”

“…Most cases of myocarditis post-vaccination presented with elevated cardiac troponin levels along with simultaneous elevations in C-reactive protein (CRP), brain natriuretic peptide (BNP) or N-terminal prohormone BNP (NT-proBNP) [7] , [9] , [24] . Interestingly, abnormal electrocardiogram findings were seen in a few patients.…”

“…Fourteen myocarditis cases presented with a left ventricular ejection fraction (LVEF) of < 50% [7] , [8] , [9] , [10] , [25] , [26] . Abnormal cardiac magnetic resonance imaging (MRI) with late gadolinium enhancement and edema were observed in 51 cases [7] , [9] , [24] , [25] , [26] , [27] . Late gadolinium enhancement was found in 41% of the patients in the subepicardial layer, 14% in the mid-myocardial layer, and 24% in both layers [9] .…”