Identification and reporting of adverse events following immunization – A prospective and observational study

Universal immunization programme monitors the efficacy and safety data related to vaccines via Adverse Events Following Immunization Secretariat and Immunization Technical Support Unit. Despite, there is a large data about AEFI; there exists a least data regarding the assessment of observed AEFIs. The objective of the study is to identify, report and assess the AEFIs for causality, severity, predictability and preventability. The prospective and observational study enrolled eligible subjects of age 0-14 weeks receiving vaccination from the immunization center at NRI general and multi-specialty hospital, Guntur, Andhra Pradesh. The study participants were monitored for 30 minutes post-vaccination and a telephonic survey was conducted after one week to identify AEFIs. All the AEFIs were assessed for causality, severity, predictability, preventability using appropriate scales. The incidence rate of observed AEFIs after Pentavalent-I dose was found to be 92.26. The most frequently observed AEFI was fever (26.62%) followed by Erythema (28.08%), swelling (25.21%), crying for 24 hrs (19.33%) and crying for 48 hr (3.33%). Upon causality assessment all the AEFIs were found to be consistent and vaccine product related reactions. 51.23% of AEFIs were found to be mild and rest was moderate in their severity. All the AEFIs were found to be predictable and 26.62% of AEFIs were preventable. Incidence rates of AEFIs were much higher than similar, previous studies. There existsno immunization-error related, vaccine-quality related, immunization-anxiety related reactions in our study. AEFI identification and reporting should be made mandatory at all clinics to know the incidence rates and severity among different population and to predict and prevent the severe AEFIs.