由于以前的研究检查与COVID-19疫苗以外的疫苗相关的心肌炎和心包炎的不良报告的局限性,在全球范围内建立对疫苗安全性的全面了解存在挑战。因此,本研究的目的是研究疫苗相关心包炎和心肌炎的全球负担以及与这些适应症相关的疫苗.本研究利用世界卫生组织国际药物警戒数据库,从其中提取了1969年至2023年之间疫苗相关心包炎和心肌炎的记录(超过1.3亿份报告)。我们计算了全球报告计数,报告赔率比(ROR),和信息成分(IC)来辨别156个国家和地区的19种疫苗与心包炎和心肌炎的发生之间的关联。我们确定了49096例报告(男性,n=30013)在73590例全因性心包炎和心肌炎的报告中,疫苗相关的心包炎和心肌炎。随着时间的推移,疫苗相关心脏不良事件的报告显着增加,2020年后观察到值得注意的激增,这归因于与COVID-19mRNA疫苗相关的心包炎病例。天花疫苗与大多数心包炎和心肌炎报告相关(ROR:73.68[95%CI,67.79-80.10];IC[IC0.25]:6.05[5.91]),其次是COVID-19mRNA疫苗(37.77[37.00-38.56];3.07[3.05]),炭疽疫苗(25.54[22.37-29.16];4.58[4.35]),伤寒疫苗(6.17[5.16-7.38];2.59[2.29]),脑炎疫苗(2.00[1.48-2.71];0.99[0.47]),流感疫苗(1.87[1.71-2.04];0.90[0.75]),和Ad5载体COVID-19疫苗(1.40[1.34-1.46];0.46[0.39])。关于年龄和性别特定的风险,疫苗相关心包炎和心肌炎的报告在男性和年龄较大的人群中更为普遍.12至17岁的年龄组表现出明显的性别不相称。大多数这些不良事件的发病时间短(中位时间:1天),死亡率为0.44%。我们对全球数据的分析显示,与疫苗相关的心包炎和心肌炎报告有所增加,特别是像天花和炭疽这样的活疫苗,尤其是年轻男性。虽然这些不良事件通常是罕见且轻微的,谨慎是必要的,特别是对于医护人员来说,由于潜在的心肌损伤相关的院内死亡率。经过验证的报告的进一步研究对于提高评估疫苗与心脏病之间的相关性以采取预防措施的准确性至关重要。
Due to the limitation of previous studies examining adverse
reports of myocarditis and pericarditis associated with vaccines other than the COVID-19 vaccine, there are challenges in establishing a comprehensive understanding of vaccine safety on a global scale. Hence, the objective of this study was to examine the worldwide burden of vaccine-associated pericarditis and myocarditis and the vaccines associated with these indications. This study utilized the World Health Organization international pharmacovigilance database, from which records of vaccine-associated pericarditis and myocarditis between 1969 and 2023 were extracted (over 130 million reports). We calculated global reporting counts, reported odds ratios (RORs), and information components (ICs) to discern the association between 19 vaccines and the occurrence of pericarditis and myocarditis across 156 countries and territories. We identified 49 096
reports (male, n = 30 013) of vaccine-associated pericarditis and myocarditis among 73 590
reports of all-cause pericarditis and myocarditis. There has been a significant increase in
reports of vaccine-related cardiac adverse events over time, with a noteworthy surge observed after 2020, attributed to cases of pericarditis associated with COVID-19 mRNA vaccines. Smallpox vaccines were associated with most pericarditis and myocarditis
reports (ROR: 73.68 [95% CI, 67.79-80.10]; IC [IC0.25]: 6.05 [5.91]), followed by COVID-19 mRNA vaccine (37.77 [37.00-38.56]; 3.07 [3.05]), anthrax vaccine (25.54 [22.37-29.16]; 4.58 [4.35]), typhoid vaccine (6.17 [5.16-7.38]; 2.59 [2.29]), encephalitis vaccine (2.00 [1.48-2.71]; 0.99 [0.47]), influenza vaccine (1.87 [1.71-2.04]; 0.90 [0.75]), and Ad5-vectored COVID-19 vaccine (1.40 [1.34-1.46]; 0.46 [0.39]). Concerning age and sex-specific risks, reports of vaccine-associated pericarditis and myocarditis were more prevalent among males and in older age groups. The age group between 12 and 17 years exhibited significant sex disproportion. Most of these adverse events had a short time to onset (median time: 1 day) and fatality rate was 0.44%. Our analysis of global data revealed an increase in pericarditis and myocarditis reports associated with vaccines, particularly live vaccines like smallpox and anthrax, notably in young males. While these adverse events are generally rare and mild, caution is warranted, especially for healthcare workers, due to potential myocardial injury-related in-hospital mortality. Further study with validated reporting is crucial to enhance accuracy in evaluating the correlation between vaccines and cardiac conditions for preventive measures.