Bleeding as Coincidental Adverse Event in Expanded Program of Immunization in Indonesia

Background. Indonesia has high prevalence of Hepatitis B infection; therefore the Expanded Program of Immunization includes Hepatitis B. Bleeding may occur as coincidental adverse event following immunization (AEFI). Vitamin K deficiency is one of bleeding causes in newborns in first months of life. Ministry of Health (MOH) implements the vitamin K administration shortly after birth prior to first Hepatitis B injection. Not all infants receive vitamin K, particularly if delivery occurs at home. Objective. To determine the prevalence and possible causes of bleeding as AEFI. Methods. We collected and analyzed AEFI data reported by Provincial AEFI Committee to the National AEFI Committee, from 1998 until 2008. Results. Of 1100 AEFI cases reported, there were 65 bleeding cases which all proven as coincidental events. Bleeding occurred between one day to 4 months age, as earliest 2 hours and latest 8th day after Hepatitis B, DPT or BCG vaccination. The common bleeding locations were at injection site and intracranial,mostly recovered by administering vitamin K. Of 192 AEFI death cases, 38 patients died due to bleeding and case fatality rate was 58.46%. Death cases were those who were late or not seeking medical treatment or reported from verbal autopsy. Conclusions. Bleeding occurred after immunization revealed to be coincidental AEFI. A complete and detailed AEFI case report is needed to define the category and cause of AEFI. Vitamin K1 should be given prior the first intramuscular Hepatitis B vaccination to prevent some causes of bleeding. The MOH needs to take further evaluation and action.