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Volume 11
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10.3390/biomedicines11061584
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Article

COVID-19 Vaccines and Atrial Fibrillation: Analysis of the Post-Marketing Pharmacovigilance European Database

by
Rosanna Ruggiero
1,2,†,
Maria Donniacuo
2,†,
Annamaria Mascolo
1,2,
Mario Gaio
1,2,
Donato Cappetta
3,
Concetta Rafaniello
1,2,
Giovanni Docimo
4,
Consiglia Riccardi
1,2,*,
Imma Izzo
1,2,
Donatella Ruggiero
1,2,
Giuseppe Paolisso
4,
Francesco Rossi
1,2,
Antonella De Angelis
2,‡ and
Annalisa Capuano
1,2,‡
1
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy
2
Department of Experimental Medicine, University of Campania L. Vanvitelli, 80138 Naples, Italy
3
Department of Biological and Environmental Sciences and Technologies, University of Salento, 73100 Lecce, Italy
4
Department of Advanced Medical and Surgical Sciences, University of Campania L. Vanvitelli, 80138 Naples, Italy
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work and shared the first authorship.
‡
These authors also contributed equally to this work and shared the last authorship.
Biomedicines 2023, 11(6), 1584; https://doi.org/10.3390/biomedicines11061584
Submission received: 10 May 2023 / Revised: 25 May 2023 / Accepted: 27 May 2023 / Published: 30 May 2023
(This article belongs to the Special Issue Cardiovascular Health in COVID-19: Pathophysiology and Therapeutic Perspective)
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Abstract

Atrial fibrillation (AF) has been described in COVID-19 patients. Recently, some case reports and US pharmacovigilance analyses described AF onset as a rare adverse event following COVID-19 vaccination. The possible correlation is unclear. We systematically analyzed the reports of AF related to COVID-19 vaccines collected in the European pharmacovigilance database, EudraVigilance (EV), from 2020 to November 2022. We carried out descriptive and disproportionality analyses. Moreover, we performed a sensitivity analysis, excluding the reports describing other possible alternative AF causes (pericarditis, myocarditis, COVID-19, or other drugs that may cause/exacerbate AF). Overall, we retrieved 6226 reports, which represented only 0.3% of all those related to COVID-19 vaccines collected in EV during our study period. AF reports mainly referred to adults (in particular, >65 years old), with an equal distribution in sex. Reports were mainly related to tozinameran (54.04%), elasomeran (28.3%), and ChAdOx1-S (14.32%). The reported AF required patient hospitalization in 35% of cases and resulted in a life-threatening condition in 10% of cases. The AF duration (when reported) was highly variable, but the majority of the events had a short duration (moda = 24 h). Although an increased frequency of AF reporting with mRNA vaccines emerges from our study, other investigations are required to investigate the possible correlation between COVID-19 vaccination and the rare AF occurrence.
Keywords: atrial fibrillation; adverse events following immunization; COVID-19 vaccines; post-marketing surveillance; EudraVigilance; cardiac safety atrial fibrillation; adverse events following immunization; COVID-19 vaccines; post-marketing surveillance; EudraVigilance; cardiac safety

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MDPI and ACS Style

Ruggiero, R.; Donniacuo, M.; Mascolo, A.; Gaio, M.; Cappetta, D.; Rafaniello, C.; Docimo, G.; Riccardi, C.; Izzo, I.; Ruggiero, D.; et al. COVID-19 Vaccines and Atrial Fibrillation: Analysis of the Post-Marketing Pharmacovigilance European Database. Biomedicines 2023, 11, 1584. https://doi.org/10.3390/biomedicines11061584

AMA Style

Ruggiero R, Donniacuo M, Mascolo A, Gaio M, Cappetta D, Rafaniello C, Docimo G, Riccardi C, Izzo I, Ruggiero D, et al. COVID-19 Vaccines and Atrial Fibrillation: Analysis of the Post-Marketing Pharmacovigilance European Database. Biomedicines. 2023; 11(6):1584. https://doi.org/10.3390/biomedicines11061584

Chicago/Turabian Style

Ruggiero, Rosanna, Maria Donniacuo, Annamaria Mascolo, Mario Gaio, Donato Cappetta, Concetta Rafaniello, Giovanni Docimo, Consiglia Riccardi, Imma Izzo, Donatella Ruggiero, and et al. 2023. "COVID-19 Vaccines and Atrial Fibrillation: Analysis of the Post-Marketing Pharmacovigilance European Database" Biomedicines 11, no. 6: 1584. https://doi.org/10.3390/biomedicines11061584

APA Style

Ruggiero, R., Donniacuo, M., Mascolo, A., Gaio, M., Cappetta, D., Rafaniello, C., Docimo, G., Riccardi, C., Izzo, I., Ruggiero, D., Paolisso, G., Rossi, F., De Angelis, A., & Capuano, A. (2023). COVID-19 Vaccines and Atrial Fibrillation: Analysis of the Post-Marketing Pharmacovigilance European Database. Biomedicines, 11(6), 1584. https://doi.org/10.3390/biomedicines11061584

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