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Purpose <p>This study aimed to investigate the cumulative incidence of adverse events of special interest (AESI) among Iranians who were vaccinated with COVID-19 vaccines, including Sinopharm, Sputnik V, AZD1222, and COVIran Barekat.</p> Methods <p>Using World Health Organization guidelines, this cohort event monitoring (CEM) study was conducted to assess the adverse events of COVID-19 vaccines, in seven cities in Iran. A total of 89783 participants (31690 Sinopharm, 20195 Sputnik V, 23780 AZD1222, and 14118 CoVIran Barekat) who were 18 or older were followed up for 17&#xa0;weeks (25&#xa0;weeks for AZD1222) after receiving the first dose of vaccine by weekly phone contacts or self-reporting in a web application. Furthermore, all hospitalized cases were investigated for causes of admission by classification committees.</p> Results <p>A total of 11 cases (cumulative incidence: 12.3 per 100,000) of AESIs were recorded. All of the AESI cases were observed among 2080 hospitalized cases. The AESIs included five cases of coagulation disorders (three after AZD1222 and two after Sinopharm vaccination), and three cases of generalized seizure (one after Sputnik V, and two cases after AZD1222). In addition, two cases of Guillain–Barre syndrome, and Sub-acute Thyroiditis were detected after receiving Sputnik V, and one individual developed pericarditis after receiving COVIran Barekat.</p> Conclusion <p>We found around one AESI among every 8,000 vaccinated Iranian people. The incidence of AESIs after COVID-19 vaccines was relatively rare and the studied vaccines can be considered safe. AZD1222 had a higher incidence of AESIs. Coagulation disorders, and generalized seizure were the main and most common AESIs.</p>

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Adverse events of special interest after vaccination with COVID-19 vaccines: a cohort event monitoring study in Iran

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月18日

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  • Roqayeh Aliyari,
  • Mohammad Hassan Emamian,
  • Sepideh Mahdavi,
  • Mostafa Enayatrad,
  • Sajad Sahab-Negah,
  • Sairan Nili,
  • Mohammad Fereidouni,
  • Parvin Mangolian shahrbabaki,
  • Alireza Ansari-Moghadam,
  • Fariba Shahraki-Sanavi,
  • Mansooreh Fateh,
  • Hamidreza Khajeha,
  • Zahra Emamian,
  • Elahe Behmanesh,
  • Hamid Sharifi

摘要

Purpose

This study aimed to investigate the cumulative incidence of adverse events of special interest (AESI) among Iranians who were vaccinated with COVID-19 vaccines, including Sinopharm, Sputnik V, AZD1222, and COVIran Barekat.

Methods

Using World Health Organization guidelines, this cohort event monitoring (CEM) study was conducted to assess the adverse events of COVID-19 vaccines, in seven cities in Iran. A total of 89783 participants (31690 Sinopharm, 20195 Sputnik V, 23780 AZD1222, and 14118 CoVIran Barekat) who were 18 or older were followed up for 17 weeks (25 weeks for AZD1222) after receiving the first dose of vaccine by weekly phone contacts or self-reporting in a web application. Furthermore, all hospitalized cases were investigated for causes of admission by classification committees.

Results

A total of 11 cases (cumulative incidence: 12.3 per 100,000) of AESIs were recorded. All of the AESI cases were observed among 2080 hospitalized cases. The AESIs included five cases of coagulation disorders (three after AZD1222 and two after Sinopharm vaccination), and three cases of generalized seizure (one after Sputnik V, and two cases after AZD1222). In addition, two cases of Guillain–Barre syndrome, and Sub-acute Thyroiditis were detected after receiving Sputnik V, and one individual developed pericarditis after receiving COVIran Barekat.

Conclusion

We found around one AESI among every 8,000 vaccinated Iranian people. The incidence of AESIs after COVID-19 vaccines was relatively rare and the studied vaccines can be considered safe. AZD1222 had a higher incidence of AESIs. Coagulation disorders, and generalized seizure were the main and most common AESIs.