ANALYSIS OF SERIOUS ADVERSE EVENTS FOLLOWING IMMUNIZATION IN CHILDREN BELOW THE AGE OF 5 YEARS – A BIOVIGILANCE STUDY

Background: The WHO has defined AEFI (Adverse events following immunization) as “any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the vaccine usage”. The incidence was 13.7% in our country. Vaccine safety surveillance studies are the need of the hour in developing countries to maintain public trust in vaccines since there are limited number of vaccine vigilance studies, the current study is being taken up. Materials and Methods: It was a retrospective observational study conducted in the Department of Pediatrics at Victoria Hospital attached to BMCRI. The study was conducted in November and December 2022. The data were collected from patient case records from the year 2018 to 2022. Totally 30 adverse events were reported in that time period. Results: Most of the AEFI were reported in the age group of 0-6 years (66.6%). Proportion of male was found to be more than female. Most of the AEFI were reported following Pentavalent (40%) followed by BCG (23.3%), and MR vaccine (20%). The systemic reactions were reported as a serious adverse event (56.6%) than local reactions (43.3%). Conclusion: Most common systemic reaction was fever with rashes followed by convulsions, and in local reactions, injection site abscess followed by lymphadenitis. The study shows some reactions are treated following AEFI. Identifying and treating these AEFIs is quite challenging. So, we have to create awareness about AEFIs so as to treat them as early as possible, and also helpful in preventing some product-related side effects.