Adverse Event Following Immunization (AEFI) Associated With COVID-19 Vaccine Reported In A Tertiary Hospital: A Cross-Sectional Study

Abstract

Introduction:
COVID-19 vaccine is the most effective preventive measure to curb the spread of COVID-19 infection. Monitoring of COVID-19 vaccine safety is important as no vaccine is completely risk-free and adverse events following immunization (AEFI) are possible. The aim of the study is to investigate AEFI associated with COVID-19 vaccines among adult patients visiting Hospital Kuala Lumpur (HKL). The specific objectives are to identify the types and severity of AEFI, determine the common management of AEFI and explore the associated factors that affects the severity of AEFI.
Methods:
This study was a single centre, retrospective cross-sectional study using secondary data obtained from AEFI reporting submitted to HKL. All patients who received the COVID-19 vaccine and reported AEFI were included in this study. Logistic regression analysis were used to assess associated factors that may affect the severity of AEFI.
Results:
A total of 263 AEFI reports were included in the final analysis. Majority of the patients were presented with systemic reactions (n= 207, 78.7%) and minor reactions (n = 228, 86.7%). Intravenous steroid (n=122, 46.4%) was the most common medication administered for management of AEFI. The identified factors associated with AEFI severity include the use mRNA vaccine (aOR 0.07, 95% CI 0.02-0.22, P <0.001), male gender (aOR 2.72, 95%CI 1.17-6.33, P= 0.020), presence of comorbidities (aOR 3.50, 95% CI 1.48-8.27, P= 0.004), underlying hypertension (aOR 9.88, 95% CI 1.45-67.34, P =0.019) and respiratory disease (aOR 7.73, 95% CI 1.27-47.04, P= 0.027)
Conclusion:
Majority of the reported AEFI were systemic and minor reactions. Intravenous steroid was the common drug administered for the management of AEFI. The identified factors associated with AEFI severity highlight the need for enhanced monitoring and tailored management strategies to address AEFI, particularly in individuals with known risk factors.