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贝鲁特大学社区报告的辉瑞/生物新技术(BNT162b2) COVID-19 疫苗的副作用。

Side effects of Pfizer/BioNTech (BNT162b2) COVID-19 vaccine reported by the Birzeit University community.

机构信息

Pharmacy Department, Faculty of Pharmacy, Nursing and Health Professions, Birzeit University, Birzeit, West Bank, Palestine.

出版信息

BMC Infect Dis. 2023 Jan 5;23(1):5. doi: 10.1186/s12879-022-07974-3.


DOI:10.1186/s12879-022-07974-3
PMID:36604613
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9814351/
Abstract

BACKGROUND: The Pfizer BioNTech COVID-19 vaccine was the first to receive emergency authorization and approval from the FDA. Therefore, it is preferred by most recipients; however, many people are concerned about the vaccine's side effects. At the time of the study, December 2021, Palestine lacked a national reporting system for monitoring adverse vaccine effects. Therefore, this study investigates the post-vaccine adverse events following the Pfizer/BioNTech COVID-19 Vaccine administration in Palestine and identifies the occurrence, extent, and severity among university staff, employees, and students at Birzeit University. METHOD: A questionnaire-based retrospective cross-sectional study was conducted using a university website (Ritaj), social media platforms (e.g., Facebook and Telegram), and in-person interviews. The Chi-square, Fisher's exact, and McNemar's tests were used to investigate significant relationships. Data were analyzed using SPSS version 22. RESULTS: In total, 1137 participants completed the questionnaire, 33.2% were males, and the mean age was 21.163 years. All participants received at least one dose of the Pfizer-BioNTech COVID-19 vaccine. Approximately one-third of participants reported no adverse effects after receiving the first, second, or third doses (34%, 33.6%, and 32.5%, respectively). The most commonly reported adverse events were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Allergic reactions were reported by 12.7% of the participants; furthermore, participants with a history of allergy or anaphylaxis before vaccination had a significantly higher tendency for post-vaccination allergic reactions. Eight participants reported rare side effects, including 7 (0.6%) cases of thrombocytopenia and one (0.1%) case of myocarditis. Males aged less than 20 years and smokers were significantly less likely to complain of adverse events. The number of reported side effects was significantly higher after the second vaccine dose than after the first dose. Finally, participants infected with COVID-19 before vaccination was significantly associated with side effects such as fever, chills, shortness of breath, and persistent cough. CONCLUSION: In this study, the most common post- BNT162b2 Vaccination reported self-limiting side effects similar to those reported by Pfizer/BioNTech Company. However, higher rates of allergic reactions were reported in this sample. Rare side effects, such as thrombocytopenia and myocarditis, were reported by 8 participants. COVID vaccines have been developed at an accelerated pace, and vaccine safety is a top priority; therefore, standard monitoring through a national adverse event reporting system is necessary for safety assurance. Continuous monitoring and long-term studies are required to ensure vaccine safety.

摘要

背景:辉瑞-生物技术公司的 COVID-19 疫苗是首个获得 FDA 紧急授权和批准的疫苗。因此,它是大多数接种者的首选;然而,许多人担心疫苗的副作用。在研究时,2021 年 12 月,巴勒斯坦缺乏监测疫苗不良反应的国家报告系统。因此,本研究调查了巴勒斯坦辉瑞/生物技术公司 COVID-19 疫苗接种后的疫苗后不良反应事件,并确定了在比尔宰特大学的教职员工、员工和学生中的发生、程度和严重程度。

方法:采用基于问卷的回顾性横断面研究,使用大学网站(Ritaj)、社交媒体平台(如 Facebook 和 Telegram)和面对面访谈。采用卡方检验、Fisher 确切检验和 McNemar 检验来调查显著关系。使用 SPSS 版本 22 进行数据分析。

结果:共有 1137 名参与者完成了问卷,其中 33.2%为男性,平均年龄为 21.163 岁。所有参与者均至少接种了一剂辉瑞-生物技术公司的 COVID-19 疫苗。约三分之一的参与者在接种第一、第二或第三剂后报告没有不良反应(分别为 34%、33.6%和 32.5%)。最常见的不良反应是发热、寒战、头痛、疲劳、注射部位疼痛和肿胀、肌肉疼痛和关节疼痛。12.7%的参与者报告了过敏反应;此外,接种疫苗前有过敏或过敏反应史的参与者接种后发生过敏反应的倾向明显更高。有 8 名参与者报告了罕见的副作用,包括 7 例(0.6%)血小板减少症和 1 例(0.1%)心肌炎。年龄小于 20 岁的男性和吸烟者发生不良反应的可能性显著较低。第二剂疫苗后报告的副作用数量明显高于第一剂。最后,接种疫苗前感染 COVID-19 的参与者与发热、寒战、呼吸急促和持续咳嗽等副作用显著相关。

结论:在这项研究中,报告的最常见的 BNT162b2 疫苗接种后自限性副作用与辉瑞/生物技术公司报告的相似。然而,在本样本中报告了更高的过敏反应率。有 8 名参与者报告了罕见的副作用,如血小板减少症和心肌炎。COVID 疫苗的研发速度很快,疫苗安全性是重中之重;因此,需要通过国家不良事件报告系统进行标准监测,以确保安全性。需要持续监测和长期研究以确保疫苗的安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/76c4a67b395b/12879_2022_7974_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/2484032fce9d/12879_2022_7974_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/24155a0331a5/12879_2022_7974_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/ebf7ab17600e/12879_2022_7974_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/4a6101ef0388/12879_2022_7974_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/d01fa01277e7/12879_2022_7974_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/76c4a67b395b/12879_2022_7974_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/2484032fce9d/12879_2022_7974_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/9436f7192496/12879_2022_7974_Fig2_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/4a6101ef0388/12879_2022_7974_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/d01fa01277e7/12879_2022_7974_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c95/9814351/76c4a67b395b/12879_2022_7974_Fig7_HTML.jpg

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