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Background: Safety of vaccines is more critical because they are used for immunization in children and Hepatitis-B vaccination is included in national immunization schedule for neonates and infants in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) monitors the adverse drug reactions/Adverse events (ADR/AE) associated with the drugs used in the country through WHO reporting system, VigiFlow. Objective of the study is to analyse ADR/AEs associated with Hepatitis B vaccination reported to NCC-PvPI through Vigi- Flow database. Methods: Retrospective analysis of the VigiFlow data were extracted and analysed with respect to patient demography, profession of reporter, system organ class (SOC) affected, causality assessment, seriousness of adverse event and year wise analysis of reported ADRs. Results: During the study period 295 ADR/AEs were reported following Hepatitis B vaccination. The adverse reactions following Hepatitis B immunization were primarily reported in infants (55.2 %) in age group 1-2 years. The causality assessment showed that 42.7% of the adverse events are probable/likely associated with Hepatitis B vaccination. Most of the cases were reported by the physician. The two main ADRs were fever 58.9% and injection site pain 11.5%. Conclusion: Data analyzed in our study showed only non-serious reactions were reported due to hepatitis B vaccination. Data also clearly showed that there is a need for reporting ADR/AEs associated with quality of vaccines that may affect safety of the vaccine, which may be possible by amending the suspected adverse drug reaction reporting form of NCC-PvPI. Key words: NCC-PvPI, Hepatitis B vaccine, ADR/AE, VigiFlow, System organ class (SOC)

Adverse Reactions after Hepatitis B Vaccination: A Retrospective Analysis Using Spontaneous Reports