[Literature review of adverse events following immunization of Bacillus Calemtte-Guerin vaccine].

Objective: This article is to analyze the features of adverse events following immunization (AEFI) in BCG Literatures, and to provide information for AEFI surveillance and diagnosis.

Methods: The literatures were collected from CHKD and WANFANG databases, then the information from qualified publications were analysed.

Results: 100 cases from 90 publications were involved. >10 literatures were published every year in 2000-2007. 65% cases occurred < or =1 day and > or =15 days after vaccination. 54% cases occurred in the first dose. 21 cases were local redness and swelling, 16 cases were local indurations. 15 cases were suppurative lymphadenitis. 66% cases were cured. Of 100 cases, 40 were program error events, 40 cases were rare, serious vaccine reactions and 18 were coincidental illnesses. In all practice error events, 28 were using BCG as other vaccines and 12 were vaccination error. 71 of 100 cases were diagnosed by author, 17 by hospital, 9 by CDC and 3 by the expert group for AEFI diagnosis.

Conclusions: Overall, the mainly reason of BCG AEFI was operational error event. The serious cases, such as death, were related to immunological deficiency. The training of vaccination conductors and the clinical physicians should be strengthened in order to standardize the vaccination. The standardized immunization services and diagnosis of AEFI will reduce AEFI occurrence and the disputations about AEFI.