Evaluation of short-term COVID-19 vaccines adverse events following immunization severity as reported by Iraqi consumers

Abstract

Introduction: Consumer-generated Adverse Events Following Immunization (AEFI) reports are a major source of vaccine safety information in pharmacovigilance, which was unprecedented within the Iraqi settings. Methods: A self-assessment form was developed to be accessed by the consumers country-wide via the Iraqi pharmacovigilance center’s (IPvC) WhatsApp number. A retrospective analysis was then performed on the responses submitted from April 2021 until April 2022. Different independent variables were analyzed for their influence on subjective AEFI severity. Results: 2843 responses were finally included. The average number of reported AEFI was 4.03 (S.D. ± 2.58) per response and significantly different among vaccine types. Both Comirnaty and Vaxzevria-associated AEFIs were reported to affect daily life similarly (~59 %), while Sinopharm was 42.4 %. Treatment-seeking was highest in Vaxzervria reports (22.8 %). Factors associated with higher reported severity include; younger people, females, and previous COVID-19 infection. Also, for the Comirnaty vaccine, the second dose. Fever, body rash, and difficulty breathing were the most significantly associated with treatment-seeking. A very small number of serious AEFIs were also detected. Conclusion: Consumer reporting is valuable for generating data regarding COVID-19 vaccines’ AEFIs within the Iraqi spontaneous surveillance system and their engagement is recommended in the future for other medicinal products as well.