Adverse event reporting following immunization of hepatitis B vaccine: A 13-year review.

Abstract

Hepatitis B vaccination is the most effective means of interrupting HBV transmission. Although the hepatitis B vaccine is very effective and safe, adverse events following immunization do occur and need to be reported so that problems can be identified and appropriate corrective action can be taken. Most of the research on AEFI focuses on the safety observation of newly used vaccines, and there are few long-term studies on AEFI of the hepatitis B vaccine. This study retrospectively analyzes the reporting rate, clinical symptoms, and onset time of AEFI of the hepatitis B vaccine in Quzhou from 2011 to 2023, and compares the differences in AEFI reporting rates between different types of hepatitis B vaccines, different vaccination ages, and different doses. The surveillance results show that from 2011 to 2023, the AEFI reporting rate of hepatitis B Vaccines in Quzhou was 17.55/100,000 doses. 98.73% of reported AEFI were non-serious. The types of AEFI reported were vaccine product-related reactions, immunization anxiety-related reactions, and coincidental events. 94.12% of vaccine product-related reactions occurred within 3 days, and the main symptoms were fever, local reactions at the injection site, and rash. The AEFI reporting rate of the CHO vaccine was higher than that of the yeast vaccines, and the probability of AEFI in children under 1 year of age receiving the hepatitis B vaccine was higher in the latter dose than in the previous dose. The 13-year-long AEFI surveillance provides reliable evidence of the safety of the hepatitis B vaccine.