COVID-19 Vaccination Adverse Events in Children: An observational Investigation with a Control Group in Tabriz Metropolitan City

Document Type : Original Articles

Authors

1 Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran

2 Department of Epidemiology & Biostatistics, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran

3 Province Health Center, Health Chancellor, Tabriz University of Medical Sciences, Tabriz, Iran

4 Department of diseases control, Tabriz District Health Center, Tabriz University of Medical Sciences, Tabriz, Iran

5 Department of Statistics and Epidemiology School of Public Health Tabriz University of Medical Sciences

10.32592/ARI.2024.79.5.1031

Abstract

Adverse events of COVID-19 Vaccination in children are somewhat unknown, and limited population-based studies have been carried out in this age group. This study aims to determine the short-term Sinopharm and Soberana (PastoCoVac) vaccination adverse events in 5- to 12-year-old children. This study is an observational study with a control group. The cluster sampling method by considering health care centers and mass vaccination centers of Tabriz as clusters were used to recruit the study samples with a ratio of 2:1 for the vaccinated and unvaccinated groups, respectively. Information was collected by telephone calls and interviews with their parents. Data were analyzed by using a mixed-effect logistic regression model. In this study, 577 (63.2%) vaccinated and 336 (36.8%) unvaccinated children were investigated. Results demonstrated that the most frequent complication among vaccinated children was injection site pain (399 (69.2%, CI 95%: 65.2% to 72.9%)). The most frequently reported systemic adverse events among vaccinated versus unvaccinated children were fever (9.0% vs. 3.6% (0.003)), fatigue (5.5% vs. 0.9% (0.002)), and headache (2.9% vs. 0.6% (0.032)). No serious adverse events including myocarditis, multisystem inflammatory syndrome (MIS), and hospitalization were reported. The odds of having any symptoms in the vaccinated group adjusted for confounders were significantly higher than in the control group (adjusted OR=4.71, CI 95%: (3.04, 7.26), p-value<.001). According to the results, it can be concluded that Sinopharm and PastoCoVac vaccines did not have serious side effects. Also, it seems that some of the reported adverse events in other studies are overestimated due to the lack of a control group.

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References

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Archives of Razi Institute
Volume 79, Issue 5
September and October 2024
Pages 1031-1038

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