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Front Immunol . Report on adverse events of COVID-19 vaccines in Iran: a comprehensive national prospective longitudinal analysis

tetano

Editor, Senior Moderator
Front Immunol


. 2025 Feb 14:16:1504973.
doi: 10.3389/fimmu.2025.1504973. eCollection 2025. Report on adverse events of COVID-19 vaccines in Iran: a comprehensive national prospective longitudinal analysis

Hamidreza Jamaati[SUP] 1 [/SUP], Saeed Karimi[SUP] 2 [/SUP], Shahnam Arshi[SUP] 3 [/SUP], Seyed Mohsen Zahraei[SUP] 3 [/SUP], Yunes Panahi[SUP] 4 [/SUP], Fatemeh Nouri[SUP] 5 [/SUP], Maryam Hajimoradi[SUP] 5 [/SUP], Arman Hasanzade[SUP] 6 [/SUP], Majid Mokhtari[SUP] 7 [/SUP], Katayoun Tayeri[SUP] 3 [/SUP], Atefeh Abedini[SUP] 1 [/SUP], Abdolreza Mohamadnia[SUP] 1 [/SUP], Payam Tabarsi[SUP] 8 [/SUP], Babak Sharif-Kashani[SUP] 9 [/SUP], Majid Marjani[SUP] 8 [/SUP], Farin Rashid Farokhi[SUP] 10 [/SUP], Seyed Mohammad Reza Hashemian[SUP] 1 [/SUP], Fatemeh Sadat Hosseini-Baharanchi[SUP] 11 [/SUP], Mostafa Norizadeh[SUP] 12 [/SUP], Bahamin Astani[SUP] 5 [/SUP], Sima Noorali[SUP] 5 [/SUP], Farnaz Ahmadi[SUP] 5 [/SUP], Shadi Shafaghi[SUP] #[/SUP][SUP] 5 [/SUP], Fariba Ghorbani[SUP] #[/SUP][SUP] 6 [/SUP]



Affiliations
Abstract

Introduction: The global coronavirus disease 2019 (COVID-19) pandemic necessitated urgent vaccine development, raising concerns about potential vaccine adverse events (AEs).
Methods: 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.
Results: 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%).
Discussion: In conclusion, the AEs of COVID-19 vaccination were primarily mild and transient, while serious AEs remained exceptionally rare.

Keywords: COVID-19 vaccination; Iran; adverse events; complication; safety; vaccination.

 
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