Faculty of Medicine, Medical University of Gdańsk, Marii Skłodowskiej-Curie 3a, 80-210 Gdańsk, Poland.
Department of Allergology, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214 Gdańsk, Poland.
Eur Heart J Cardiovasc Pharmacother. 2024 Nov 6;10(7):599-607. doi: 10.1093/ehjcvp/pvae063.
We aimed to analyse serious cardiac adverse drug reactions to COVID-19 vaccines from the Europe-wide EudraVigilance database.
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.
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.
我们旨在从欧洲范围内的 EudraVigilance 数据库中分析与 COVID-19 疫苗相关的严重心脏不良药物反应。
在这项回顾性、横断面研究中，我们从 EudraVigilance 数据库中搜索了与 COVID-19 疫苗接种后疑似严重心脏不良药物反应相关的可疑病例。将这些数据与欧洲疾病预防控制中心“疫苗追踪”数据库中 Comirnaty（辉瑞 BioNTech）、Spikevax（莫德纳）、Vaxzevria（阿斯利康）、Jcovden（杨森）、Nuvaxovid（诺瓦瓦克斯）疫苗的总接种剂量进行了耦合。分析包括来自“疫苗追踪”数据库的 772228309 剂合格疫苗和 EudraVigilance 数据库的 86051 例合格的心脏不良药物反应记录。调查的大多数不良药物反应的频率都非常罕见（<1/10000，即<100/1000000 剂）。接种 Comirnaty 的严重心脏不良药物反应风险最低（每百万剂 135.5 例），而 Spikevax、Jcovden、Vaxzevria 和 Nuvaxovid 的风险较高（分别为每百万剂 140.9、194.8、313.6 和 1065.2 例）。接种疫苗最常见的并发症包括晕厥、心律失常、心动过速、心悸、心绞痛、高血压、心肌炎、血栓形成和肺栓塞。
COVID-19 疫苗的严重心脏不良药物反应风险较低，积极接种该疫苗预防该疾病的益处似乎超过了接种后严重心脏不良药物反应的潜在风险。
