Objective  To analyze characteristics of mortalities after inoculation of hepatitis B vaccine (HepB) for assess the safety of the vaccine.

  Methods  We searched for reports on mortalities after HepB vaccination published between 1993 and 2017 through China National Knowledge Infrastructure (CNKI), Wanfang Database, Chinese Scientific Journals Full-Text Database (VIP), and PubMed with the key words of HepB, adverse events following immunization (AEFI), death, and China. We extracted death cases' data on demographics, dose of inoculation, and death cause using Excel 2007 and analyzed the data with descriptive epidemiologic method.

  Results  Among the 648 literatures preliminarily searched, 59 reports for 90 dead cases were included in the study. The age of the reported deaths ranged from 2 hours to 5 years old and 85.56% (77) of the deaths were at the ages of 1 to 6 months. There were 71.11% (64) of the deaths related to the inoculation of the 2nd dose of HepB. For all the deaths based on the classification of AEFI, 82.22% (74) were coincidental events; 16.67% (15) were abnormal responses; and one case (1.11%) was of unknown cause. Autopsy was performed among 60.00% (54 cases) of all cases and the autopsy examinations attributed 18.52% (10) of the death cause to anaphylactic shock and 81.48% to coincidental events such as pneumonia, congenital diseases, vitamin K deficiency, and sudden infant death syndrome.

  Conclusion  The mortality after inoculation of hepatitis B vaccine is very rare in China and the main causes for the mortalities are coincidental events and the vaccine-related anaphylactic shock.