Abstract

Introduction: The COVID-19 pandemic has significantly impacted Yemen, a country already facing severe humanitarian challenges. The introduction of COVID-19 vaccines prompted the need to monitor adverse events following immunization (AEFIs) to ensure safety and efficacy. Therefore, this study aimed to identify the types and outcomes of adverse events that the Yemeni National Pharmacovigilance Center received after the COVID-19 immunization during 2022.

Methods: This observational descriptive cross-sectional study analyzed the secondary data from the Yemeni National Pharmacovigilance Center of reported AEFIs during 2022. By using AEFI reporting form, data about AEFIs types and outcomes were collected and entered into the Vigibase database. Data were categorized as serious or non-serious based on World Health Organization (WHO) criteria.

Results: A total of 205AEFIs reports were received. Two thirds (66.8%) of reports of male recipients and 77.0% of the received reports for vaccine recipients aged between 18-44 years. The majority (73.2%) of reported AEFIs related to Janssen COVID-19 vaccine NRVV Ad26 (JNJ 78436735) and the most commonly reported adverse events were fever (69.6%), headache (30.4%), and arthralgia (23.0%). Serious adverse events were rare, comprising only 3.4% of total reports.

Conclusion: The number of reported AEFI post COVID-19 vaccinations was very low related to the total vaccinated population and the identified adverse events are more or less similar to the typical symptoms of most previous vaccines, and most of them were tolerated. Ongoing efforts to improve surveillance and reporting mechanisms are essential to enhance the understanding and management of vaccine-related adverse events.

Keywords: COVID-19, Vaccination, Adverse Events, Yemen, Pharmacovigilance.

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