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ORIGINAL RESEARCH article
Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 16 - 2025 |
doi: 10.3389/fimmu.2025.1504973
Report on Adverse Events of COVID-19 Vaccines in Iran: A Comprehensive National Prospective Longitudinal Analysis
Provisionally accepted
Hamid Reza Jamaati 1
Saeed Karimi 2* Shahnam Arshi 3*
Seyed Mohsen Zahraei 3 Yunes Panahi 4* Fatemeh Nouri 5*
Maryam Hajimoradi 5
Arman Hasanzade 6
Majid Mokhtari 7 Katayoun Tayeri 3*
Atefeh Abedini 1 Abdolreza Mohamadnia 1*
Payam Tabarsi 8 Babak Sharif-Kashani 9*
Majid Marjani 8 Farin Rashid Farokhi 10*
Seyed Mohammad Reza Hashemian 1 Fatemeh Sadat Hosseini-Baharanchi 11*
Mostafa Noorizadeh 12 Bahamin Astani 5* Sima Noorali 5* Farnaz Ahmadi 5* Shadi Shafaghi 5*
Fariba Ghorbani 6*- 1 Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Tehran, Alborz, Iran
- 2 Department of Ophthalmology, Torfeh Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran
- 3 Center for Communicable Disease Control, Ministry of Health and Medical Education, Tehran, Iran, Tehran, Iran
- 4 Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran, Tehran, Iran
- 5 Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Alborz, Iran
- 6 Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases , Shahid Beheshti University of Medical Sciences, Tehran, Iran., Tehran, Alborz, Iran
- 7 Department of Pulmonary and Critical Care Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran
- 8 Clinical Tuberculosis and Epidemiology Research Center, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran., Tehran, Iran
- 9 Department of Cardiology, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
- 10 Chronic Kidney Disease Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
- 11 Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran
- 12 Department of Biotechnology, Islamic Azad University of Medical Science, Tehran, Iran
The global coronavirus disease 2019 (COVID-19) pandemic necessitated urgent vaccine development, raising concerns about potential vaccine adverse events (AEs). In this prospective cohort study, conducted from February 2021 to December 2022, all individuals across Iran who received any COVID-19 vaccine dose and reported adverse events were investigated. Our aim was to evaluate these AEs based on the vaccine types, patients' age and types of AES, and provide a comprehensive analysis. In Iran, 155 million COVID-19 vaccine doses were administered, with Covilo (Sinopharm) being the most commonly vaccine administered (80.35%). Adverse events predominantly affected individuals aged 40-70 (45%). A total of 86,275 adverse events were recorded, with 92.7% classified as non-serious and 6 299 (7.3%) serious and among the serious cases, 279 were confirmed to be vaccine-related, with 46 resulting in fatalities and 233 requiring hospitalizations. The incidence of serious AEs was 0.41 per 10,000 doses. Serious AEs were more frequently associated with Sputnik V and Vaxzevria (AstraZeneca), with 0.73 and 0.64 cases per 10,000 injections, respectively. Coagulation and thrombosis disorders were the most common serious AEs (29%), followed by neurological (24.7%) and cardiovascular AEs (15.8%). In conclusion, the AEs of COVID-19 vaccination were primarily mild and transient, while serious AEs remained exceptionally rare.
Keywords: SARS-CoV-2: Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Vaccination, Iran, adverse events, complication, Safety, Vaccination Font: (Default) +Headings CS (Times New Roman), 12 pt, Complex Script Font: +Headings CS (Times New Roman)
Received: 01 Oct 2024; Accepted: 27 Jan 2025.
Copyright: © 2025 Jamaati, Karimi, Arshi, Zahraei, Panahi, Nouri, Hajimoradi, Hasanzade, Mokhtari, Tayeri, Abedini, Mohamadnia, Tabarsi, Sharif-Kashani, Marjani, Rashid Farokhi, Hashemian, Hosseini-Baharanchi, Noorizadeh, Astani, Noorali, Ahmadi, Shafaghi and Ghorbani. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Saeed Karimi, Department of Ophthalmology, Torfeh Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran
Shahnam Arshi, Center for Communicable Disease Control, Ministry of Health and Medical Education, Tehran, Iran, Tehran, Iran
Yunes Panahi, Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran, Tehran, Iran
Fatemeh Nouri, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Alborz, Iran
Katayoun Tayeri, Center for Communicable Disease Control, Ministry of Health and Medical Education, Tehran, Iran, Tehran, Iran
Abdolreza Mohamadnia, Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Tehran, Alborz, Iran
Babak Sharif-Kashani, Department of Cardiology, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Farin Rashid Farokhi, Chronic Kidney Disease Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Fatemeh Sadat Hosseini-Baharanchi, Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran
Bahamin Astani, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Alborz, Iran
Sima Noorali, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Alborz, Iran
Farnaz Ahmadi, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Alborz, Iran
Shadi Shafaghi, Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Alborz, Iran
Fariba Ghorbani, Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases , Shahid Beheshti University of Medical Sciences, Tehran, Iran., Tehran, Alborz, Iran
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