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马来西亚单中心研究:医护人员接种 BNT162b2 mRNA COVID-19 疫苗后的不良事件。

Adverse events following BNT162b2 mRNA COVID-19 vaccination among healthcare workers: A single-centre experience in Malaysia.

机构信息

Hospital Tuanku Ja'afar Seremban, Clinical Research Centre, Negeri Sembilan, Malaysia.

Hospital Tuanku Ja'afar Seremban, Occupational Safety and Health Unit, Negeri Sembilan, Malaysia.

出版信息

Med J Malaysia. 2022 May;77(3):300-305.

PMID:35638485
Abstract

INTRODUCTION

The COVID-19 pandemic is a global health crisis that has resulted in a massive disease burden worldwide. Mass vaccination plays an important role in controlling the spread and severity of COVID-19 infections worldwide.

MATERIALS AND METHODS

A cross-sectional study was conducted in Hospital Tuanku Ja'afar Seremban between 1 March 2021 and 4 May 2021 to describe the adverse events (AE) following BNT162b2 (Pfizer-BioNTech) vaccination. Healthcare personnel who received at least one dose of the vaccine were invited to complete an online questionnaire.

RESULTS

Of 2282 analysed samples, AE were experienced in up to 64.5% (n=1472) of the study participants. Most AE were encountered after the second dose (56.5%, n=832). Pain at the injection site (41.5%, n=944), fever (35.1%, n=798) and lethargy (34.8%, n=792) were the most commonly reported AE. Severe AEFI were reported in a minority (2.9%, n=68). There were no documented anaphylaxis, vaccine-induced thrombosis, or myocarditis. The proportion of female recipients and recipients with a history of allergy were higher in the AE group compared to the non-AE group.

CONCLUSION

Our study reinforces the safety of the BNT162b2 mRNA vaccine in the local population. The main adverse events were mild, although they occurred in most patients.

摘要

简介

COVID-19 大流行是一场全球性的卫生危机,给全世界带来了巨大的疾病负担。全球范围内大规模接种疫苗对于控制 COVID-19 感染的传播和严重程度发挥了重要作用。

材料与方法

本研究于 2021 年 3 月 1 日至 5 月 4 日在 Hospital Tuanku Ja'afar Seremban 进行了一项横断面研究,旨在描述 BNT162b2(辉瑞-生物科技)疫苗接种后的不良反应(AE)。邀请至少接种过一剂疫苗的医护人员完成在线问卷。

结果

在分析的 2282 个样本中,高达 64.5%(n=1472)的研究参与者经历了 AE。大多数 AE 发生在第二剂之后(56.5%,n=832)。最常报告的 AE 为注射部位疼痛(41.5%,n=944)、发热(35.1%,n=798)和乏力(34.8%,n=792)。少数报告了严重的 AEFI(2.9%,n=68)。未记录到过敏反应、疫苗诱导的血栓形成或心肌炎。与非 AE 组相比,AE 组中女性接受者和有过敏史的接受者比例更高。

结论

本研究证实了 BNT162b2 mRNA 疫苗在当地人群中的安全性。主要不良反应为轻度,但发生在大多数患者中。

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