Overview of COVID-19 Vaccine Adverse Events Following Immunization in Bali

Abstract

Adverse event following immunization (AEFI) is undesired medical events that occur post-vaccination without considering whether there is a cause-and-effect relationship with the use of the vaccine or not. COVID-19 vaccination is an ongoing vaccination but the AEFI research is still limited, especially in Bali. This study aimed to report the overview of COVID-19 vaccine AEFI in Bali during January 2021 – December 2022. This was a descriptive study with cross-sectional approach by using the recapitulation data of the COVID-19 vaccine AEFI reports from the Bali Provincial Health Service. Of 958 cases, AEFI cases of COVID-19 vaccine were dominated by females (61.38%), age group of 18 – 29 years (38.73%), and domiciled in Denpasar (38.62%). The majority of adverse reaction reports were obtained from the hospital (53.34%), post vaccination of Sinovac (41.34%), and after the first dose (68.72%). The most frequently reported COVID-19 vaccine AEFI cases were non-serious AEFI (94.57%) with the most common symptoms in the local reaction group was pain at the injection site (9.65%), in the systemic reaction group was fever (17.77%), and in the other reaction group was shortness of breath (1.79%). In conclusion, AEFI of COVID-19 vaccine in Bali was dominated by females, age 18 – 29 years, and domiciled in Denpasar with most reports obtained from hospitals, post-vaccination of Sinovac, and after the first dose. The most reported AEFI cases were non-serious AEFIs where the most common symptoms were pain at the injection site for local reactions, fever for systemic reactions, and breathing difficulty for other reactions. Keywords: COVID-19 vaccine, AEFI, side effect, adverse event