Adverse Events of Vaccination against Hepatitis B Virus in Post-Marketing Surveillance from 2005 to 2017 in Guangdong Province, China.

Abstract

The present study focused on the adverse events following the vaccination against hepatitis B virus (HBV) in the Guangdong Province of China between 2005 and 2017. In total, more than 88 million doses of HBV vaccine were administered in the Guangdong Province during the study period. A total of 3115 adverse events following immunization (AEFI) related to HBV vaccination occurred, with an overall incidence of 35.39 per million doses. Of these, 1801 cases were male, and 1314 were female; 74.01% (2376/3115) of the cases occurred in children aged less than 2 years; 56.05% (1746/3115) of the cases were classified as common vaccine reactions; and 30.37% (946/3115) of the cases were grouped into rare vaccine reactions. Additionally, 27.74% (864/3115) of the cases were classified as allergic reactions, 0.10% (3/3115) were temporary neurological events, and 1.28% (36/3115) were diagnosed as severe adverse events. This study suggested that the HBV vaccine posed a reasonable profile because most adverse events remained relatively mild, and the neurological events were relatively rare. This study concluded that the incidence of severe vaccine reactions related to HBV vaccination are extremely low.