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接种 COVID-19 疫苗第一针后的不良反应。

Adverse Events Following the First Dose of Immunization of COVID-19 Vaccine.

机构信息

Drug and Patient Safety Unit, Lumbini Provincial Hospital, Rupandehi, Nepal.

Department of Clinical Pharmacology, KIST Medical College and Teaching Hospital, Lalitpur, Nepal.

出版信息

J Nepal Health Res Counc. 2022 Jun 2;20(1):59-64. doi: 10.33314/jnhrc.v20i01.3810.

DOI:10.33314/jnhrc.v20i01.3810
PMID:35945854
Abstract

BACKGROUND

The COVID-19 pandemic has challenged the entire globe and the need for a vaccine is supreme. Since many vaccines along with Covishield have been granted emergency use authorization, the evaluation and monitoring of safety are crucial. Covishield was rolled out in Nepal on January 27, 2021. So through this study, we aim to identify the prevalence of Adverse Events Following Immunization in general with the first dose of Covishield vaccine, compare Adverse Events Following Immunization in prior COVID-19 positive cases and Adverse Events Following Immunization in co-morbid individuals.

METHODS

This was a descriptive cross-sectional study conducted in 440 sample from May 2021 till July 2021 in a provincial government hospital of western Nepal. Ethical approval was received from Ethical Review Board, Nepal Health Research Council (Registration no: 279/2021 P). Simple random sampling was used. Point estimate was done at 95% confidence interval and descriptive analysis was done to identify the prevalence of Adverse Events Following Immunization within one week after Covishield vaccination in the studied population.

RESULTS

79.77% of the study population complaint at least one or more Adverse Events Following Immunization. Fever, myalgia, headache, pain at the injection site, arthralgia, chills, and fever are the most common Adverse Events Following Immunization. 42.73% of the study population self-medicated to manage Adverse Events Following Immunization, 7.89% took leave from work while 0.28% needed medical attention. No major Adverse Events Following Immunization relevance with prior-COVID history or co-morbidity was seen.

CONCLUSIONS

Majority of the vaccinated participants had minor adverse effects on the first-day post-vaccination while most of the Adverse Events Following Immunization subsided within seven days.

摘要

背景

COVID-19 大流行挑战了全球,对疫苗的需求至关重要。由于许多疫苗和 Covishield 已获得紧急使用授权,因此评估和监测安全性至关重要。Covishield 于 2021 年 1 月 27 日在尼泊尔推出。因此,通过这项研究,我们旨在确定一般人群接种第一剂 Covishield 疫苗后的不良反应发生率,比较既往 COVID-19 阳性病例和合并症患者的不良反应发生率。

方法

这是一项描述性的横断面研究,于 2021 年 5 月至 2021 年 7 月在尼泊尔西部的一家省级政府医院对 440 名样本进行了研究。本研究已获得尼泊尔健康研究委员会伦理审查委员会的伦理批准(注册号:279/2021 P)。采用简单随机抽样。点估计在 95%置信区间内进行,描述性分析用于确定研究人群中接种 Covishield 疫苗后一周内不良反应的发生率。

结果

79.77%的研究人群至少报告了一种或多种不良反应。发热、肌痛、头痛、注射部位疼痛、关节痛、寒战和发热是最常见的不良反应。42.73%的研究人群自行用药来管理不良反应,7.89%的人请假,而 0.28%的人需要医疗关注。未发现不良反应与既往 COVID 病史或合并症有明显相关性。

结论

大多数接种疫苗的参与者在接种后第一天出现轻微不良反应,大多数不良反应在七天内消退。

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