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

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: COVID-19 vaccines; EudraVigilance; adverse events following immunization; atrial fibrillation; cardiac safety; post-marketing surveillance.

Figure 1

Distribution of atrial fibrillation duration following COVID-19 vaccination and listed as suspected adverse event in EudraVigilance database.

Figure 2

Reporting odds ratios (RORs) obtained on individual case safety reports collected in EudraVigilance from December 2020 to November 2022 and reporting atrial fibrillation following COVID-19 vaccination. Vaccines included were the mRNA-based vaccines elasomeran (Moderna) and tozinameran (Pfizer-BioNTech) and the viral vector vaccines AD26.COV2.S (Janssen) and ChAdOx1-S (Astrazeneca).

Figure 3

Sensitivity analysis applying reporting odds ratio (ROR) on individual case safety reports collected in EudraVigilance from December 2020 to November 2022 and reporting atrial fibrillation following COVID-19 vaccination. Vaccines included were the mRNA-based vaccines elasomeran (Moderna) and tozinameran (Pfizer-BioNTech) and the viral vector vaccines AD26.COV2.S (Janssen) and ChAdOx1-S (Astrazeneca). For this sensitivity analysis, ICSRs reporting confounding factors for AF occurrence were excluded.