接种BNT162b2 mRNA COVID-19疫苗后的静脉管疾病:一个回顾性的病例系列
Helmi Ammar1, Christine Le Beller1, Didier Bouccara2,3
1Pharmacovigilance Regional Centre, Hôpital Européen Georges Pompidou, AP-HP-Université Paris Cité, Paris, France.
Fundamental & clinical pharmacology
|July 20, 2023
概括
在接种BNT162b2 mRNA COVID-19疫苗后,静脉管疾病 (VDs) 是一种罕见的潜在不良影响. 报告率为每百万接种疫苗的个人中26例阴道疾病,头是最常见的症状.
科学领域:
- 神经学 神经学
- 疫苗学 疫苗学 疫苗学
- 药物监督 药物监督 药物监督
背景情况:
- 关于BNT162b2 mRNA COVID-19疫苗接种后的前体疾病 (VDs) 的出版物有限.
- 调查COVID-19疫苗的潜在不良影响对于公共卫生至关重要.
- 了解罕见的副作用有助于做出明智的疫苗接种决定.
研究的目的:
- 描述可能与BNT162b2疫苗接种相关的静脉疾病病例.
- 为了计算BNT162b2接种疫苗后的VD报告率.
- 增强有关这种特定不良影响的知识.
主要方法:
- 对2021年向法国药监中心报告的风险病例的回顾性分析.
- 使用标准化MedDRA查询 (SMQ) 来识别"前体疾病".
- 根据静脉疾病病例和接种疫苗的个人计算报告率.
主要成果:
- 在6608个报告的COVID-19疫苗病例中,有34个体内疾病与BNT162b2疫苗接种有关.
- 大多数VD发生在女性 (79%),第一剂后 (62%),32%是严重的.
- 和平衡障碍是最常见的;38%的病例完全消失.
结论:
- 虽然没有确立因果关系,但体内疾病是BNT162b2疫苗接种的罕见潜在不良影响.
- 在接种BNT162b2.2.疫苗的患者中,临床医生应保持对VD的警.
- 进一步的研究可能会澄清COVID-19疫苗接种与前体健康之间的关联.
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