[Post-Vaccination Adverse Events Related To The Administration Of The Covishield® Coronavirus Vaccine In Vaccinated Volunteers At The Bamako Dermatology Hospital From April To June 2021].

Le Mali medical Pub Date : 2024-01-01
Oumar Coulibaly, Yaya Ibrahim Coulibaly, Mamadou Kodio, Mamadou Karim Touré, Abdoulaye Mamadou Traore, Mahamoud Mahamadou Koureichi, Kaman Dembélé, Mamadou Mady Keita, Oumar Traore, Korotoumou Traore, Kadiatou Diallo, Moussa Sangare, Diadje Tanapo, Abdoul Fatao Diabaté, Adama Aguissa Dicko, Claude Akakpo, Ousmane Faye
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Abstract

Objective: The aim of this study was to investigate adverse events related to the administration of Covishield vaccine from the AstraZeneca laboratory in volunteers vaccinated at the Dermatology Hospital of Bamako.

Methodology: This was a Phase IV clinical trial involving volunteers vaccinated at the Dermatology Hospital of Bamako from April to June 2021. Scientific and ethical aspects were reviewed and addressed. The proposal for this study was approved by the scientific committee of the Hôpital de Dermatologie de Bamako.

Results: A total of 1099 volunteers were included in the study. The median age of participants was 48 years (18-93 years) with a sex ratio of 1.81 (708/391). In all 90.2% of the 1219 adverse events were injection-site pain. Other adverse events were headache, tiredness, and muscle pain, with 3.2% (39/1219), 2.4% (29/1219) and 1.8% (22/1219) respectively. Only one case of diarrhea was reported, 0.08% (1/1219).

Conclusion: Adverse events to this vaccine were mostly moderate and temporary but vary according to the population vaccinated individuals.

[2021年4月至6月在巴马科皮肤病医院接种Covishield®冠状病毒疫苗的志愿者接种后出现的不良事件]。
研究目的本研究旨在调查在巴马科皮肤病医院接种阿斯利康实验室生产的 Covishield 疫苗的志愿者中发生的不良事件:这是一项 IV 期临床试验,涉及 2021 年 4 月至 6 月在巴马科皮肤病医院接种疫苗的志愿者。对科学和伦理方面进行了审查和处理。研究提案已获得巴马科皮肤病医院科学委员会批准:共有 1099 名志愿者参与了研究。参与者的年龄中位数为 48 岁(18-93 岁),性别比例为 1.81(708/391)。在 1219 例不良反应中,90.2% 为注射部位疼痛。其他不良反应包括头痛、疲倦和肌肉疼痛,分别占 3.2%(39/1219)、2.4%(29/1219)和 1.8%(22/1219)。只有一例腹泻报告,占 0.08%(1/1219):结论:该疫苗的不良反应大多为中度和暂时性,但因接种人群而异。
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