COVID-19 Vaccine Safety in Adults: A Narrative Review of Adverse Reactions in ASEAN Countries
Sažetak
The spread of the SARS-CoV-2 virus, known as the COVID-19 virus, which causes the coronavirus disease 2019 known as “COVID-19”, has led to a rapid response from governments around the world. In response to the significant threat it presents to global health, comprehensive strategies have been implemented to mitigate worldwide transmission and reduce mortality rate. Association of South East Asian Nations (ASEAN) countries have also taken steps to encourage people to get vaccinated. The use of vaccines from many global pharmaceutical companies has led to the collection of reports on adverse drug reactions to monitor and evaluate the use of pharmaceutical products after administrated. This study aimed to evaluate the adverse drug reactions of COVID-19 vaccines administered in ASEAN countries through a narrative review of relevant scientific literature. A narrative review was conducted using PubMed and ScienceDirect databases to identify original, open-access studies published between 2020 and 2025. Eligible articles involved adults aged 18–59 years and reported adverse events following COVID-19 vaccination in ASEAN countries. Nine studies met the inclusion criteria and were qualitatively analysed. Six vaccines were evaluated: Ad26.COV2.S (Johnson &Johnson), AZD1222 (AstraZeneca), BNT162b2 (Pfizer-BioNTech), CoronaVac (Sinovac), Sputnik V and mRNA-1273 (Moderna). The most adverse drug reactions reported included injection site pain, fever, headache, fatigue and muscle pain, respectively, based on the severity of side effects. Current evidence confirms that COVID-19 vaccines used in Southeast Asian demonstrated favourable safety and tolerability profiles among adults, consistent with global pharmacovigilance data. These findings support continued vaccination programs and highlight the importance of strengthening regional pharmacovigilance systems and harmonised AEFI reporting to sustain public confidence in immunisation efforts across ASEAN.
Reference
Mathieu E, Ritchie H, Ortiz Ospina E, Roser M, Hasell J, Appel C, et al. A global database of COVID 19 vaccinations. Nat Hum Behav. 2021 Jul;5(7):947–53. doi: 10.1038/s41562-021-01122-8.
World Health Organization. WHO Coronavirus (COVID 19) Dashboard [Internet]. 2025 [Cited:22-Jun-2025]. Available from: https://covid19.who.int/.
Kalinke U, Barouch DH, Rizzi R, Lagkadinou E, Türeci Ö, Pather S, et al. Clinical development and approval of COVID 19 vaccines. Expert Rev Vaccines. 2022;21:609–19. doi: 10.1080/14760584.2022.2042257.
Barouch DH. COVID 19 vaccines — immunity, variants, boosters. N Engl J Med. 2022 Sep 15;387(11):1011–20. doi: 10.1056/NEJMra2206573.
U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document [Internet]. 2020. [Cited:22-Jun-2025]. Available from: https://www.fda.gov/.
European Medicines Agency. Safety of COVID 19 vaccines [Internet]. 2021 [Cited:22-Jun-2025]. Available from: https://www.ema.europa.eu/.
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid 19 vaccine. N Engl J Med. 2020 Dec 31;383(27):2603–15. doi: 10.1056/NEJMoa2034577.
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA 1273 SARS CoV 2 vaccine. N Engl J Med. 2021 Feb 4;384(5):403–16. doi: 10.1056/NEJMoa2035389.
Fu JYL, Pukhari MH, Cruz KA Dela, Soebandrio A, Van Tan L, Jantarabenjakul W, et al. Charting the path forward in Southeast Asia: learning from the COVID 19 vaccination challenges in six ASEAN countries. J Glob Health. 2024;14:03016. doi: 10.7189/jogh.14.03016.
UNICEF. COVAX: ensuring global equitable access to COVID 19 vaccines [Internet]. 2021 [Cited:22-Jun-2025]. Available from: https://www.unicef.org/supply/covax-ensuring-global-equitable-access-covid-19-vaccines.
Garashi HY, Steinke DT, Schafheutle EI. A systematic review of pharmacovigilance systems in developing countries using the WHO pharmacovigilance indicators. Ther Innov Regul Sci. 2022;56:717–43. doi: 10.1007/s43441-022-00415-y.
Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic thrombocytopenia after ChAdOx1 nCov 19 vaccination. N Engl J Med. 2021 Jun 3;384(22):2092–101. doi: 10.1056/NEJMoa2104840.
Li X, Ostropolets A, Makadia R, Shoaibi A, Rao G, Sena AG, et al. Characterising the background incidence rates of adverse events of special interest for COVID 19 vaccines in eight countries: multinational network cohort study. BMJ. 2021 Jun 14;373:n1435. doi: 10.1136/bmj.n1435.
Karam R, Iskandar K, Watfa M, Zeitoun A. Serious adverse events following immunization with COVID 19 vaccines in Lebanon: a retrospective analysis of the national pharmacovigilance database. BMC Public Health. 2024 Oct 21;24(1):2905. doi: 10.1186/s12889-024-20297-z.
Suwankesawong W, Dhippayom T, Tan Koi WC, Kongkaew C. Pharmacovigilance activities in ASEAN countries. Pharmacoepidemiol Drug Saf. 2016 Sep;25(9):1061–9. doi: 10.1002/pds.4023.
Tan Lim CSC, Gonzales MLAM, Dans LF, Cordero CP, Alejandria MM, dela Paz ECC, et al. Reinfection rates, change in antibody titers and adverse events after COVID 19 vaccination among patients previously infected with COVID 19 in Metro Manila, Philippines: a secondary analysis of a completed cohort study. BMC Infect Dis. 2023 Dec 1;23(1):634. doi: 10.1186/s12879-023-08743-6.
Supangat, Sakinah EN, Nugraha MY, Qodar TS, Mulyono BW, Tohari AI. COVID 19 vaccines programs: adverse events following immunization (AEFI) among medical clerkship students in Jember, Indonesia. BMC Pharmacol Toxicol. 2021 Dec 1;22(1):64. doi: 10.1186/s40360-021-00528-4.
Simatupang A, Sitompul YRMB, Simanungkalit B, Kurniyanto K, Achmad LN, Sitompul F, et al. Adverse event following immunisation of adsorbed-inactivated Coronavac (Sinovac) and ChAdOx1 nCOV-19 (Astra Zeneca) of COVID-19 vaccines. Med J Malaysia. 2024 Sep;79(5):507-11. PMID: 39352150.
Ramatillah DL, Gan SH, Novarticia J, Araminda GN, Michael M, Elnaem M, et al. Side effects of CoronaVac® COVID 19 vaccination: investigation in North Jakarta district public health center communities in Indonesia. Heliyon. 2024 May 15;10(9):e30087. doi: 10.1016/j.heliyon.2024.e30087.
Benjamanukul S, Traiyan S, Yorsaeng R, Vichaiwattana P, Sudhinaraset N, Wanlapakorn N, et al. Safety and immunogenicity of inactivated COVID 19 vaccine in health care workers. J Med Virol. 2022 Apr;94(4):1442–9. PMID:34783049.
Gan LL, Zahidah AR, Hazirah T, Nabilah HK, Aisyah Z, Amin INM, et al. Adverse events following BNT162b2 mRNA COVID 19 vaccination among healthcare workers: a single centre experience in Malaysia. Med J Malaysia. 2022 May;77(3):300–5. PMID:35638485.
Tawinprai K, Siripongboonsitti T, Porntharukchareon T, Dechates B, Monprach H, Sornsamdang G, et al. Persistence of immunogenicity, contributing factors of an immune response, and reactogenicities after a single dose of the ChAdOx1 (AZD1222) COVID 19 vaccine in the Thai population. Hum Vaccin Immunother. 2022 Dec 31;18(1):2035573. doi: 10.1080/21645515.2022.2035573.
Lim SM, Chan HC, Santosa A, Quek SC, Liu EHC, Somani J. Safety and side effect profile of Pfizer BioNTech COVID 19 vaccination among healthcare workers: a tertiary hospital experience in Singapore. Ann Acad Med Singap. 2021 Sep;50(9):703–11. doi: 10.47102/annals-acadmedsg.2021160.
Rahmat H, Leelavathi M, Wan Ismail WF. Adverse events following immunisation of COVID 19 vaccine among health care workers in the first phase of vaccination. Med J Malaysia. 2022 Nov;77(6):637–42. PMID:36448378.
Tamin S, Bashiruddin J, Zachreini I, Priyono H, Mayangsari ID, Ranakusuma R, et al. Factors affecting SARS CoV 2 vaccine’s adverse events. eJKI (eJ Kedokt Indones). 2022 Aug;10(2):xx. doi: 10.23886/ejki.10.165.129.
Tanriover MD, Doğanay HL, Akova M, Güner HR, Azap A, Akhan S, et al. Efficacy and safety of an inactivated whole virion SARS CoV 2 vaccine (CoronaVac): interim results of a double blind, randomised, placebo controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213–22. doi: 10.1016/S0140-6736(21)02787-2.
Taş BG, Demir İ, Basanmay M, Öztürk GZ, Akyol BÇ, Tektaş MH, et al. Frequency and factors associated with adverse reactions after administration of inactivated COVID 19 vaccine among health workers. Rev Soc Bras Med Trop. 2023 Sep 22;56:e01522023. doi: 10.1590/0037-8682-0152-2023.
Jiesisibieke ZL, Liu WY, Yang YP, Chien CW, Tung TH. Effectiveness and safety of COVID 19 vaccinations: an umbrella meta analysis. Int J Public Health. 2023;68:1605526. doi: 10.3389/ijph.2023.1605526. PMID:37485047.
Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, et al. Vaccine side effects and SARS CoV 2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis. 2021 Jul;21(7):939-949. doi: 10.1016/S1473-3099(21)00224-3.
Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, et al. Safety and immunogenicity of ChAdOx1 nCoV 19 vaccine administered in a prime boost regimen in young and old adults (COV002): a single blind, randomised, controlled, phase 2/3 trial. Lancet. 2020 Dec 19;396(10267):1979–93. doi: 10.1016/S0140-6736(20)32466-1.
Alghamdi AN, Alotaibi MI, Alqahtani AS, Al Aboud D, Abdel Moneim AS. BNT162b2 and ChAdOx1 SARS CoV 2 post vaccination side effects among Saudi vaccinees. Front Med (Lausanne). 2021 Oct 8;8:760047. doi: 10.3389/fmed.2021.760047.
Al Bahrani S, Albarrak A, Alghamdi OA, Alghamdi MA, Hakami FH, Al Abaadi AK, et al. Safety and reactogenicity of the ChAdOx1 (AZD1222) COVID 19 vaccine in Saudi Arabia. Int J Infect Dis. 2021 Sep;110:359–62. doi: 10.1016/j.ijid.2021.07.052.
Park C, Sakong J, Jo S, Kim M, Baek K. Adverse effects on work and daily life interference among healthcare workers after the first and second ChAdOx1 and BNT162b2 COVID 19 vaccine doses. Vaccines (Basel). 2021 Aug 19;9(8):926. doi: 10.3390/vaccines9080926.
Falsey AR, Sobieszczyk ME, Hirsch I, Sproule S, Robb ML, Corey L, et al. Phase 3 safety and efficacy of AZD1222 (ChAdOx1 nCoV 19) Covid 19 vaccine. N Engl J Med. 2021 Dec 16;385(25):2348–60. doi: 10.1056/NEJMoa2105290.
Amer SA, Al Zahrani A, Imam EA, Ishteiwy EM, Djelleb IF, Abdullh LR, et al. Exploring the reported adverse effects of COVID 19 vaccines among vaccinated Arab populations: a multi national survey study. Sci Rep. 2024 Feb 27;14(1):4785. doi: 10.1038/s41598-024-54886-0.
Babamahmoodi F, Saeedi M, Alizadeh Navaei R, Hedayatizadeh Omran A, Mousavi SA, Ovaise G, et al. Side effects and immunogenicity following administration of the Sputnik V COVID 19 vaccine in health care workers in Iran. Sci Rep. 2021 Nov 2;11(1):21464. doi: 10.1038/s41598-021-00963-7.
Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector based heterologous prime boost COVID 19 vaccine: interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671–81. doi: 10.1016/S0140-6736(21)00234-8.
Montalti M, Soldà G, Di Valerio Z, Salussolia A, Lenzi J, Forcellini M, et al. ROCCA observational study: early results on safety of Sputnik V vaccine (Gam COVID Vac) in the Republic of San Marino using active surveillance. EClinicalMedicine. 2021 Aug;38:101027. doi: 10.1016/j.eclinm.2021.101027.
Zare H, Rezapour H, Mahmoodzadeh S, Fereidouni M. Prevalence of COVID 19 vaccine (Sputnik V, AZD 1222, and Covaxin) side effects among healthcare workers in Birjand city, Iran. Int Immunopharmacol. 2021 Dec;101:108351. doi: 10.1016/j.intimp.2021.108351.
Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. Safety and efficacy of single dose Ad26.COV2.S vaccine against Covid 19. N Engl J Med. 2021 Jun 10;384(23):2187–201. doi: 10.1056/NEJMoa2101544.
Tsuchiya Y, Tamura H, Fujii K, Numaguchi H, Toyoizumi K, Liu T, et al. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: results of a phase 1, randomized, double blind, placebo controlled COVID 19 vaccine trial in Japan. Vaccine. 2023 Feb;41(9):1602–10. doi: 10.1016/j.vaccine.2023.01.006.
Woo EJ, Gee J, Marquez P, Baggs J, Abara WE, McNeil MM, et al. Post authorization safety surveillance of Ad.26.COV2.S vaccine: reports to VAERS and v safe, February 2021–February 2022. Vaccine. 2023 Jul;41(30):4422–30. doi: 10.1016/j.vaccine.2023.06.023.
Hanson KE, Goddard K, Lewis N, Fireman B, Myers TR, Bakshi N, et al. Incidence of Guillain Barré syndrome after COVID 19 vaccination in the Vaccine Safety Datalink. JAMA Netw Open. 2022 Apr 26;5(4):e228879. doi: 10.1001/jamanetworkopen.2022.8879.
U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document [Internet]. 2020 Dec. [Cited:22-Jun-2025]. Available from: https://www.fda.gov/.
Ab Rahman N, Lim MT, Lee FY, Lee SC, Ramli A, Saharudin SN, et al. Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: a self controlled case series study. Vaccine. 2022 Jul;40(32):4394–402. doi: 10.1016/j.vaccine.2022.05.075.
Barda N, Dagan N, Ben Shlomo Y, Kepten E, Waxman J, Ohana R, et al. Safety of the BNT162b2 mRNA Covid 19 vaccine in a nationwide setting. N Engl J Med. 2021 Sep 16;385(12):1078–90. doi: 10.1056/NEJMoa2110475.
García Grimshaw M, Ceballos Liceaga SE, Hernández Vanegas LE, Núñez I, Hernández Valdivia N, Carrillo García DA, et al. Neurologic adverse events among 704,003 first dose recipients of the BNT162b2 mRNA COVID 19 vaccine in Mexico: a nationwide descriptive study. Clin Immunol. 2021 Aug;229:108786. doi: 10.1016/j.clim.2021.108786.
Santi Laurini G, Montanaro N, Broccoli M, Bonaldo G, Motola D. Real life safety profile of mRNA vaccines for COVID 19: an analysis of the VAERS database. Vaccine. 2023 May;41(18):2879–86. doi: 10.1016/j.vaccine.2023.03.054.
Ito S, Tsuchida N, Kusunoki S, Kaneko Y, Naito T, Hori S, et al. Safety comparison between Pfizer BNT162b2, Moderna mRNA 1273, and AstraZeneca AZD1222 in a nationwide prospective cohort survey at the beginning of SARS CoV 2 vaccination in Japan. Vaccine. 2025 Mar;49:126754. doi: 10.1016/j.vaccine.2025.126754.
Sinovac Life Sciences Co., Ltd. COVID 19 Vaccine (Vero Cell), Inactivated — CoronaVac®: Product Information Leaflet [Internet]. 2022 Mar [Cited:30-May-2025]. Available from: internal product leaflet (COR Philippines 40 vials insert EN D03.pdf).
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).