{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T10:57:24Z","timestamp":1768647444276,"version":"3.49.0"},"reference-count":41,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T00:00:00Z","timestamp":1675123200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>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\u2019s 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 \u226518 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% (n = 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 \u00b1 4.4 (n = 349), 2.2 \u00b1 3.6 (n = 202) and 3.5 \u00b1 4.1 (n = 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 (p = 0.014). Patients with chronic disease indicated significantly higher (p = 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.<\/jats:p>","DOI":"10.3390\/vaccines11020315","type":"journal-article","created":{"date-parts":[[2023,2,1]],"date-time":"2023-02-01T02:52:02Z","timestamp":1675219922000},"page":"315","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A First Report on Side-Effects of COVID-19 Vaccines among General Population in Sudan: A Cross-Sectional Analysis"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8751-4159","authenticated-orcid":false,"given":"Malik Suliman","family":"Mohamed","sequence":"first","affiliation":[{"name":"Department of Pharmaceutics, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia"},{"name":"Department of Pharmaceutics, Faculty of Pharmacy, University of Khartoum, Khartoum P.O. Box 1996, Sudan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5472-1151","authenticated-orcid":false,"given":"Ahmed Osman","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Microbiology, Faculty of Pharmacy, International University of Africa, Khartoum P.O. Box 2469, Sudan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8954-7250","authenticated-orcid":false,"given":"Rawaf","family":"Alenazy","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory, College of Applied Medical Sciences-Shaqra, Shaqra University, Shaqra 11961, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9479-6147","authenticated-orcid":false,"given":"Yusra Habib","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mona Timan","family":"Idriss","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences and Preparation Year, Northern College of Nursing, Arar 73312, Saudi Arabia"},{"name":"Department of Pharmaceutics, Faculty of Pharmacy, Imperial University College, Khartoum 11111, Sudan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noura A. A.","family":"Alhudaib","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences and Preparation Year, Northern College of Nursing, Arar 73312, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3875-7968","authenticated-orcid":false,"given":"Tilal","family":"Elsaman","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Magdi Awadalla","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eyman M.","family":"Eltayib","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9957-5362","authenticated-orcid":false,"given":"Tauqeer Hussain","family":"Mallhi","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka 72388, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,1,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1232","DOI":"10.1080\/21645515.2020.1735227","article-title":"COVID-19, an emerging coronavirus infection: Advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics","volume":"16","author":"Dhama","year":"2020","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_2","unstructured":"WHO (2023, January 16). Coronavirus Disease (COVID-19) Pandemic, Available online: https:\/\/www.who.int\/europe\/emergencies\/situations\/covid-19."},{"key":"ref_3","first-page":"157","article-title":"WHO declares COVID-19 a pandemic","volume":"91","author":"Cucinotta","year":"2020","journal-title":"Acta Bio Med. Atenei Parm."},{"key":"ref_4","unstructured":"WHO (2023, January 16). WHO Coronavirus (COVID-19) Dashboard, Available online: https:\/\/covid19.who.int\/."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2257","DOI":"10.1093\/cid\/ciab079","article-title":"The impact of vaccination on coronavirus disease 2019 (COVID-19) outbreaks in the United States","volume":"73","author":"Moghadas","year":"2021","journal-title":"Clin. Infect. Dis."},{"key":"ref_6","unstructured":"Assistant Secretary for Public Affairs (2022, December 15). COVID-19 Vaccines, Available online: https:\/\/www.hhs.gov\/coronavirus\/covid-19-vaccines\/index.html."},{"key":"ref_7","unstructured":"SAGE (2022, December 15). COVID-19 Vaccines Technical Documents. Available online: https:\/\/www.who.int\/groups\/strategic-advisory-group-of-experts-on-immunization\/covid-19-materials."},{"key":"ref_8","unstructured":"The Republic of Sudan, Federal Ministry of Health (2022, December 15). National Deployment and Vaccination Plan for COVID-19 Vaccines. Available online: https:\/\/reliefweb.int\/sites\/reliefweb.int\/files\/resources\/sudan_covid_nvdp_final.pdf."},{"key":"ref_9","unstructured":"VIPER Group COVID19 Vaccine Tracker Team (2022, December 15). COVID19 Vaccine Tracker\u2014Sudan. Available online: https:\/\/covid19.trackvaccines.org\/country\/sudan\/."},{"key":"ref_10","unstructured":"WHO (2022, December 15). COVID-19, Available online: https:\/\/covid19.who.int\/region\/emro\/country\/sd."},{"key":"ref_11","unstructured":"Our World in Data (2022, December 18). Coronavirus (COVID-19) Vaccinations. Available online: https:\/\/ourworldindata.org\/covid-vaccinations?country=SDN."},{"key":"ref_12","unstructured":"WHO (2023, January 18). W.H.O. Global COVID-19 Data Dashboard\u2014Sudan, Available online: https:\/\/covid19.who.int\/region\/emro\/country\/sd."},{"key":"ref_13","unstructured":"UNICEF-Sudan (2023, January 18). The COVID-19 Mega Campaign: Vaccines into Vaccinations. Available online: https:\/\/www.unicef.org\/sudan\/stories\/covid-19-mega-campaign-vaccines-vaccinations."},{"key":"ref_14","unstructured":"UNICEF-Sudan (2023, January 18). COVID-19 Vaccines Information Centre. Available online: https:\/\/www.unicef.org\/sudan\/covid-19-vaccines-information-centre."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"100205","DOI":"10.1016\/j.puhip.2021.100205","article-title":"The fight against the COVID-19 pandemic: Vaccination challenges in Sudan","volume":"2","author":"Musa","year":"2021","journal-title":"Public Health Pract."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Hildreth, J.E.K., and Alcendor, D.J. (2021). Targeting COVID-19 vaccine hesitancy in minority populations in the US: Implications for herd immunity. Vaccines, 9.","DOI":"10.3390\/vaccines9050489"},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Alzarea, A.I., Khan, Y.H., Alatawi, A.D., Alanazi, A.S., Alzarea, S.I., Butt, M.H., Almalki, Z.S., Alahmari, A.K., and Mallhi, T.H. (2022). Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile. Vaccines, 10.","DOI":"10.3390\/vaccines10060924"},{"key":"ref_18","doi-asserted-by":"crossref","unstructured":"Mallhi, T.H., Khan, Y.H., Butt, M.H., Salman, M., Tanveer, N., Alotaibi, N.H., Alzarea, A.I., and Alanazi, A.S. (2022). Surveillance of Side Effects after Two Doses of COVID-19 Vaccines among Patients with Comorbid Conditions: A Sub-Cohort Analysis from Saudi Arabia. Medicina, 58.","DOI":"10.3390\/medicina58121799"},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Omar, S.M., Khalil, R., Adam, I., and Al-Wutayd, O. (2022). The Concern of COVID-19 Vaccine Safety Is behind Its Low Uptake among Patients with Diabetes Mellitus in Sudan. Vaccines, 10.","DOI":"10.3390\/vaccines10040527"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"3881","DOI":"10.1080\/21645515.2021.1963600","article-title":"Non-life-threatening adverse reactions from COVID-19 vaccine; a cross-sectional study with self-reported symptoms among Ghanaian healthcare workers","volume":"17","author":"Serwaa","year":"2021","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"937794","DOI":"10.3389\/fpubh.2022.937794","article-title":"Self-reported side effects of the Oxford AstraZeneca COVID-19 vaccine among healthcare workers in Ethiopia, Africa: A cross-sectional study","volume":"10","author":"Yesuf","year":"2022","journal-title":"Front. Public Health"},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Elnaem, M.H., Mohd Taufek, N.H., Ab Rahman, N.S., Mohd Nazar, N.I., Zin, C.S., Nuffer, W., and Turner, C.J. (2021). COVID-19 Vaccination Attitudes, Perceptions, and Side Effect Experiences in Malaysia: Do Age, Gender, and Vaccine Type Matter?. Vaccines, 9.","DOI":"10.21203\/rs.3.rs-923374\/v1"},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Desalegn, M., Garoma, G., Tamrat, H., Desta, A., and Prakash, A. (2022). The prevalence of AstraZeneca COVID-19 vaccine side effects among Nigist Eleni Mohammed memorial comprehensive specialized hospital health workers. Cross sectional survey. PLoS ONE, 17.","DOI":"10.1371\/journal.pone.0265140"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1981086","DOI":"10.1080\/21645515.2021.1981086","article-title":"Reported COVID-19 vaccines side effects among Jordanian population: A cross sectional study","volume":"18","author":"Omeish","year":"2022","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_25","first-page":"1196","article-title":"COVID-19 vaccines: Current understanding on immunogenicity, safety, and further considerations","volume":"12","author":"He","year":"2021","journal-title":"Front. Immunol."},{"key":"ref_26","first-page":"e27297","article-title":"Side Effects of COVID-19 Vaccines (Pfizer, AstraZeneca) in Saudi Arabia, Eastern Province","volume":"14","author":"Amer","year":"2022","journal-title":"Cureus"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s13337-022-00755-1","article-title":"A comprehensive review on COVID-19 vaccines: Development, effectiveness, adverse effects, distribution and challenges","volume":"33","author":"Rahman","year":"2022","journal-title":"Virusdisease"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1341","DOI":"10.15537\/smj.2021.42.12.20210576","article-title":"Post-vaccination survey for monitoring the side effects associated with COVID-19 vaccines among healthcare professionals of Jazan province, Saudi Arabia","volume":"42","author":"Ahsan","year":"2021","journal-title":"Saudi Med. J."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"106700","DOI":"10.1016\/j.cct.2022.106700","article-title":"COVID-19 vaccines: Considering sex differences in efficacy and safety","volume":"115","author":"Jensen","year":"2022","journal-title":"Contemp. Clin. Trials"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"359","DOI":"10.1016\/j.ijid.2021.07.052","article-title":"Safety and reactogenicity of the ChAdOx1 (AZD1222) COVID-19 vaccine in Saudi Arabia","volume":"110","author":"Albarrak","year":"2021","journal-title":"Int. J. Infect. Dis."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Hatmal, M.M., Al-Hatamleh, M.A.I., Olaimat, A.N., Mohamud, R., Fawaz, M., Kateeb, E.T., Alkhairy, O.K., Tayyem, R., Lounis, M., and Al-Raeei, M. (2022). Reported adverse effects and attitudes among Arab populations following COVID-19 vaccination: A large-scale multinational study implementing machine learning tools in predicting post-vaccination adverse effects based on predisposing factors. Vaccines, 10.","DOI":"10.3390\/vaccines10030366"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"408","DOI":"10.1152\/physiol.00035.2015","article-title":"Sex and gender impact immune responses to vaccines among the elderly","volume":"30","author":"Fink","year":"2015","journal-title":"Physiology"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"876336","DOI":"10.3389\/fpubh.2022.876336","article-title":"Vaccine Side Effects Following COVID-19 Vaccination Among the Residents of the UAE\u2014An Observational Study","volume":"10","author":"Ganesan","year":"2022","journal-title":"Front. Public Health"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"1796","DOI":"10.3389\/fmed.2021.760047","article-title":"BNT162b2 and ChAdOx1 SARS-CoV-2 post-vaccination side-effects among Saudi vaccinees","volume":"8","author":"Alghamdi","year":"2021","journal-title":"Front. Med."},{"key":"ref_35","doi-asserted-by":"crossref","unstructured":"Riad, A., Sa\u011f\u0131ro\u011flu, D., \u00dcst\u00fcn, B., Pokorn\u00e1, A., Klugarov\u00e1, J., Attia, S., and Klugar, M. (2021). Prevalence and risk factors of CoronaVac side effects: An independent cross-sectional study among healthcare workers in Turkey. J. Clin. Med., 10.","DOI":"10.2139\/ssrn.3820571"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"1098","DOI":"10.1037\/amp0000388","article-title":"Marriage, divorce, and the immune system","volume":"73","year":"2018","journal-title":"Am. Psychol."},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"CDC COVID-19 Response Team, and Food and Drug Administration (2021). Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine\u2014United States, December 14\u201323, 2020. Morb. Mortal. Wkly. Rep., 70, 46.","DOI":"10.15585\/mmwr.mm7002e1"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1111\/j.1600-0714.2009.00802.x","article-title":"Varicella zoster virus: Review of its management","volume":"38","author":"Mustafa","year":"2009","journal-title":"J. Oral Pathol. Med."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1016\/S0891-5520(20)30329-9","article-title":"Prospects for use of a varicella vaccine in adults","volume":"4","author":"Hardy","year":"1990","journal-title":"Infect. Dis. Clin. N. Am."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1097\/01.all.0000136758.66442.28","article-title":"Smallpox, vaccination and adverse reactions to smallpox vaccine","volume":"4","author":"Wollenberg","year":"2004","journal-title":"Curr. Opin. Allergy Clin. Immunol."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1016\/j.jhin.2011.08.004","article-title":"Effectiveness of seasonal influenza vaccination in healthcare workers: A systematic review","volume":"79","author":"Ng","year":"2011","journal-title":"J. Hosp. Infect."}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/11\/2\/315\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T18:19:22Z","timestamp":1760120362000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/11\/2\/315"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,31]]},"references-count":41,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2023,2]]}},"alternative-id":["vaccines11020315"],"URL":"https:\/\/doi.org\/10.3390\/vaccines11020315","relation":{},"ISSN":["2076-393X"],"issn-type":[{"value":"2076-393X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1,31]]}}}