Index Entries

Rosanna Ruggiero, Maria Donniacuo, Annamaria Mascolo, Mario Gaio, Donato Cappetta, Concetta Rafaniello, Giovanni Docimo, Consiglia Riccardi, Imma Izzo, Donatella Ruggiero, Giuseppe Paolisso, Francesco Rossi, Antonella De Angelis, and Annalisa Capuano
May 30, 2023
Biomedicines
University of Campania L. Vanvitelli (Italy)

"Abstract

Atrial fibrillation (AF) has been described in COVID-19 patients... 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... 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...

1. Introduction

... Alongside well-known and moderate adverse events, i.e., fever, fatigue, and pain at the site of inoculation, cardiovascular events represent the most serious complications following COVID-19 vaccination. These include myocarditis and pericarditis, mainly associated with mRNA vaccines, while immune thrombocytopenia has been mainly related to viral vector ones. Another emerging rare cardiac adverse event following anti-COVID-19 immunization is atrial fibrillation (AF). It represents the most common type of heart arrhythmia, whose development is multifactorial and can be related to different comorbidities."

document
adverse events,COVID-19,heart disorders,mRNA,vaccines