Cardiac adverse drug reactions to COVID-19 vaccines. A cross-sectional study based on the Europe-wide data

Abstract

Aims: We aimed to analyse serious cardiac adverse drug reactions to COVID-19 vaccines from the Europe-wide EudraVigilance database.

Methods and results: In this retrospective, cross-sectional study, the EudraVigilance database was searched to identify suspected serious cardiac post-vaccination adverse drug reactions to COVID-19 vaccines. This data was coupled with the number of total vaccine doses administered in the European Economic Area for Comirnaty (Pfizer BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca), Jcovden (Janssen), Nuvaxovid (Novavax), products, available from the European Centre for Disease Prevention and Control 'Vaccine Tracker' database. The analysis included 772 228 309 administered doses of eligible vaccines from the 'Vaccine Tracker' database and 86 051 eligible records of cardiac adverse drug reactions from the EudraVigilance database. The frequency of most of the investigated adverse drug reactions was very rare (<1/10 000 i.e. <100/1 000 000 doses). The lowest risk of any serious cardiac adverse drug reactions was noticed for vaccination with Comirnaty (135.5 per million doses), while Spikevax, Jcovden, Vaxzevria, and Nuvaxovid were characterized by higher risk (respectively, 140.9, 194.8, 313.6, and 1065.2 per million doses). The most common complications of vaccinations included syncope, arrhythmia, tachycardia, palpitations, angina pectoris, hypertension, myocarditis, thrombosis, and pulmonary embolism.

Conclusion: The risk of serious cardiac adverse drug reactions to COVID-19 vaccines is low and the benefit of active immunization against that disease seems to outweigh the potential risk of serious post-vaccination cardiac adverse drug reactions.

Keywords: Adverse drug reactions; COVID-19; Cardiac complications; EudraVigilance; Vaccination.