Ferchichi Khouloud, Aouinti Imen, Zaiem Ahmed, Lakhoua Ghozlane, Kaabi Widd, Charfi Ons, Kastalli Sarrah, Daghfous Riadh, Aidli Sihem El
National Center Chalbi Belkahia of Pharmacovigilance, 9 Avenue Dr Zouheïr Essafi, Tunis 1006, Tunisia.
University of Tunis El Manar, Faculty of Medicine of Tunis, Research Unit: UR17ES12, Tunis 1006, Tunisia.
Clin Immunol Commun. 2022 Dec;2:162-164. doi: 10.1016/j.clicom.2022.11.001. Epub 2022 Nov 17.
Myocarditis is an adverse reaction discovered after the marketing of SARS-CoV-2 mRNA vaccines. Nevertheless, this effect is not mentioned as an adverse reaction in the summary of product characteristics of other types of vaccines against this disease.
In this work, we aim to present the cases of myocarditis after vaccination against COVID-19 reported to the national Tunisian centre of pharmacovigilance.
We present the cases of myocarditis reported after the COVID-19 vaccination. All cases are diagnosed according to Brighton's case definition of myocarditis. The vaccines causality assessment was estimated by the French imputability updated method of Bégaud et al.
We included five patients. The sex ratio (M/F) was 4. The mean age was 30 years. All patients had no notable cardiovascular history and did not report any significant past medical history. The onset of symptoms was two days post-vaccination in three patients. The predominant reported symptoms are chest pain and dyspnea in the five cases. Cardiac magnetic resonance imaging (MRI) confirmed the myocarditis diagnosis in four patients (not performed for one patient).All cases were classified as definitive cases according to the Brighton case definition of myocarditis. No patient required hospitalization in a cardiac intensive care unit. All the patients recovered from acute myocarditis within a few days.
Reported cases of myocarditis post-COVID-19 vaccination in our population are rare, not severe, and have a quick favorable outcome.
心肌炎是在新型冠状病毒2 mRNA疫苗上市后发现的一种不良反应。然而,在其他类型的针对该疾病的疫苗的产品特征摘要中,并未将这种效应列为不良反应。
在这项研究中,我们旨在呈现向突尼斯国家药物警戒中心报告的接种新冠疫苗后发生心肌炎的病例。
我们呈现了接种新冠疫苗后报告的心肌炎病例。所有病例均根据布莱顿心肌炎病例定义进行诊断。疫苗因果关系评估采用贝高德等人更新后的法国归因法进行估算。
我们纳入了5名患者。男女比例为4。平均年龄为30岁。所有患者均无显著的心血管病史,且未报告任何重大既往病史。3名患者在接种疫苗后两天出现症状。5例患者报告的主要症状为胸痛和呼吸困难。心脏磁共振成像(MRI)确诊4例患者患有心肌炎(1例患者未进行此项检查)。根据布莱顿心肌炎病例定义,所有病例均被分类为确诊病例。没有患者需要入住心脏重症监护病房。所有患者在数天内从急性心肌炎中康复。
在我们的人群中,报告的接种新冠疫苗后发生心肌炎的病例罕见,病情不严重,且预后良好。