A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis

Background: The process of mass immunization against COVID-19 may be impacted by vaccine reluctance despite intense and ongoing efforts to boost vaccine coverage. The COVID-19 vaccine is a crucial component for controlling the pandemic. To the best of our knowledge, we did not come across any study...

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Main Authors: Malik Suliman Mohamed, Ahmed Osman Mohamed, Rawaf Alenazy, Yusra Habib Khan, Mona Timan Idriss, Noura A. A. Alhudaib, Tilal Elsaman, Magdi Awadalla Mohamed, Eyman M. Eltayib, Tauqeer Hussain Mallhi
Format: Article
Language:English
Published: MDPI AG 2023-01-01
Series:Vaccines
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Online Access:https://www.mdpi.com/2076-393X/11/2/315
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author Malik Suliman Mohamed
Ahmed Osman Mohamed
Rawaf Alenazy
Yusra Habib Khan
Mona Timan Idriss
Noura A. A. Alhudaib
Tilal Elsaman
Magdi Awadalla Mohamed
Eyman M. Eltayib
Tauqeer Hussain Mallhi
author_facet Malik Suliman Mohamed
Ahmed Osman Mohamed
Rawaf Alenazy
Yusra Habib Khan
Mona Timan Idriss
Noura A. A. Alhudaib
Tilal Elsaman
Magdi Awadalla Mohamed
Eyman M. Eltayib
Tauqeer Hussain Mallhi
author_sort Malik Suliman Mohamed
collection DOAJ
description Background: The process of mass immunization against COVID-19 may be impacted by vaccine reluctance despite intense and ongoing efforts to boost vaccine coverage. The COVID-19 vaccine is a crucial component for controlling the pandemic. To the best of our knowledge, we did not come across any study presenting the post-vaccination side-effect profile among the Sudanese population. Developing strategies to improve the vaccine acceptability and uptake necessitate evidence-based reports about vaccine’s side effects and acceptance. In this regard, this study aimed at estimating the prevalence of COVID-19 vaccine side-effects among the general population in Sudan. Methodology: A cross-sectional web-based quantitative study was conducted among the general population aged ≥18 years and residing in the Khartoum state of Sudan. A 30-item survey tool recorded the demographics, chronic diseases, allergy to other vaccines and COVID-19 vaccine side-effects after the first, second and booster doses. The data on the onset and duration of side-effects after each dose were also recorded. The distribution of side-effect scores after each dose of COVID-19 vaccine was compared using appropriate statistical methods. Results: A total of 626 participants were approached for this study. There was a preponderance of females (57.7%), and 19% of respondents had chronic diseases. The vaccination rate against COVID-19 was 55.8% (<i>n</i> = 349/626). The prevalence of side-effects after the first, second and booster doses were 79.7, 48 and 69.4%, respectively. Pain at the injection site, headache, fatigue, exhaustion and fever were the common side-effects after the first and second doses, while pain at the injection site, fatigue, headache and muscle pain were frequently reported after the booster dose. Most of these side-effects appeared within 6 h and resolved within one or two days following the administration of the vaccine dose. The average side-effects scores were 4.1 ± 4.4 (<i>n</i> = 349), 2.2 ± 3.6 (<i>n</i> = 202) and 3.5 ± 4.1 (<i>n</i> = 36) after the first, second and booster doses, respectively. The female gender had significantly higher side-effects after primary and booster doses. The age group 18-24 years indicated higher side-effects after the first dose compared to participants with ages ranging from 31 to 40 years (<i>p</i> = 0.014). Patients with chronic disease indicated significantly higher (<i>p</i> = 0.043) side-effects compared to those without any comorbid illness. Conclusions: This study showed a high prevalence of transient COVID-19 vaccine-related side-effects after primary and booster doses. However, these side-effects waned within 48 h. Pain at the injection site was the most common local side-effect, while fatigue, fever, headache and muscle pain were frequently reported systemic side-effects. The frequency of side-effects was more profound among females, young adults and those with comorbid conditions. These findings indicate that COVID-19 vaccines are safe and have side-effects as reported in the clinical trials of the vaccines. These results aid in addressing the ongoing challenges of vaccine hesitancy in the Sudanese population that is nurtured by widespread concerns over the safety profile.
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spelling doaj.art-dcaf5da398d44412bf6c773c655df7172023-11-16T23:42:41ZengMDPI AGVaccines2076-393X2023-01-0111231510.3390/vaccines11020315A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional AnalysisMalik Suliman Mohamed0Ahmed Osman Mohamed1Rawaf Alenazy2Yusra Habib Khan3Mona Timan Idriss4Noura A. A. Alhudaib5Tilal Elsaman6Magdi Awadalla Mohamed7Eyman M. Eltayib8Tauqeer Hussain Mallhi9Department of Pharmaceutics, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Pharmaceutical Microbiology, Faculty of Pharmacy, International University of Africa, Khartoum P.O. Box 2469, SudanDepartment of Medical Laboratory, College of Applied Medical Sciences-Shaqra, Shaqra University, Shaqra 11961, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Medical Sciences and Preparation Year, Northern College of Nursing, Arar 73312, Saudi ArabiaDepartment of Medical Sciences and Preparation Year, Northern College of Nursing, Arar 73312, Saudi ArabiaDepartment of Pharmaceutical Chemistry, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Pharmaceutical Chemistry, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi ArabiaBackground: The process of mass immunization against COVID-19 may be impacted by vaccine reluctance despite intense and ongoing efforts to boost vaccine coverage. The COVID-19 vaccine is a crucial component for controlling the pandemic. To the best of our knowledge, we did not come across any study presenting the post-vaccination side-effect profile among the Sudanese population. Developing strategies to improve the vaccine acceptability and uptake necessitate evidence-based reports about vaccine’s side effects and acceptance. In this regard, this study aimed at estimating the prevalence of COVID-19 vaccine side-effects among the general population in Sudan. Methodology: A cross-sectional web-based quantitative study was conducted among the general population aged ≥18 years and residing in the Khartoum state of Sudan. A 30-item survey tool recorded the demographics, chronic diseases, allergy to other vaccines and COVID-19 vaccine side-effects after the first, second and booster doses. The data on the onset and duration of side-effects after each dose were also recorded. The distribution of side-effect scores after each dose of COVID-19 vaccine was compared using appropriate statistical methods. Results: A total of 626 participants were approached for this study. There was a preponderance of females (57.7%), and 19% of respondents had chronic diseases. The vaccination rate against COVID-19 was 55.8% (<i>n</i> = 349/626). The prevalence of side-effects after the first, second and booster doses were 79.7, 48 and 69.4%, respectively. Pain at the injection site, headache, fatigue, exhaustion and fever were the common side-effects after the first and second doses, while pain at the injection site, fatigue, headache and muscle pain were frequently reported after the booster dose. Most of these side-effects appeared within 6 h and resolved within one or two days following the administration of the vaccine dose. The average side-effects scores were 4.1 ± 4.4 (<i>n</i> = 349), 2.2 ± 3.6 (<i>n</i> = 202) and 3.5 ± 4.1 (<i>n</i> = 36) after the first, second and booster doses, respectively. The female gender had significantly higher side-effects after primary and booster doses. The age group 18-24 years indicated higher side-effects after the first dose compared to participants with ages ranging from 31 to 40 years (<i>p</i> = 0.014). Patients with chronic disease indicated significantly higher (<i>p</i> = 0.043) side-effects compared to those without any comorbid illness. Conclusions: This study showed a high prevalence of transient COVID-19 vaccine-related side-effects after primary and booster doses. However, these side-effects waned within 48 h. Pain at the injection site was the most common local side-effect, while fatigue, fever, headache and muscle pain were frequently reported systemic side-effects. The frequency of side-effects was more profound among females, young adults and those with comorbid conditions. These findings indicate that COVID-19 vaccines are safe and have side-effects as reported in the clinical trials of the vaccines. These results aid in addressing the ongoing challenges of vaccine hesitancy in the Sudanese population that is nurtured by widespread concerns over the safety profile.https://www.mdpi.com/2076-393X/11/2/315side effectCOVID-19vaccineSudangeneral population
spellingShingle Malik Suliman Mohamed
Ahmed Osman Mohamed
Rawaf Alenazy
Yusra Habib Khan
Mona Timan Idriss
Noura A. A. Alhudaib
Tilal Elsaman
Magdi Awadalla Mohamed
Eyman M. Eltayib
Tauqeer Hussain Mallhi
A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis
Vaccines
side effect
COVID-19
vaccine
Sudan
general population
title A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis
title_full A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis
title_fullStr A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis
title_full_unstemmed A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis
title_short A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis
title_sort first report on side effects of covid 19 vaccines among general population in sudan a cross sectional analysis
topic side effect
COVID-19
vaccine
Sudan
general population
url https://www.mdpi.com/2076-393X/11/2/315
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