Le Mali medical · 2024
[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].
СтатьяКлиническое исследование IV фазыАннотация на английскомНазвание и аннотация: Перевод в очереди
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Coulibaly Oumar, Coulibaly Yaya Ibrahim, Kodio Mamadou, Touré Mamadou Karim, Traore Abdoulaye Mamadou, Koureichi Mahamoud Mahamadou, Dembélé Kaman, Keita Mamadou Mady, Traore Oumar, Traore Korotoumou, Diallo Kadiatou, Sangare Moussa, Tanapo Diadje, Diabaté Abdoul Fatao, Dicko Adama Aguissa, Akakpo Claude, Faye Ousmane
Аннотация
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.
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.