Monitoring the adverse events following immunization of Bacillus Calmette-Guérin vaccine in Changning District of Shanghai, 2005-2016

ObjectiveTo analyze characteristics of adverse events following immunization (AEFIs) with Bacillus Calmette-Guérin vaccine (BCG) during 2005－2016 in Changning District, Shanghai, and to evaluate the safety of BCG vaccination and the AEFI, providing reference for its monitoring, diagnosis, identification and management.

MethodsThe AEFI case data related to BCG immunization from Shanghai AEFI reporting registry and the National AEFI Surveillance System during 2005－2016 were collected for descriptive epidemiological analyses.

ResultsA total of 34 BCG AEFIs were reported during 2005－2016 in Changning District, incidence rate being 20.02 per 100 000 doses.Among the AEFIs reported, 30 (17.67 per 100 000 doses) were rare adverse reactions.Among rare adverse reactions, 18 (60.00%, 10.60 per 100 000 doses) were BCG lymphadenitis, and 11 (36.67%, 6.48 per 100 000 doses) were local abscess.One case was identified as disseminated BCG infection.

ConclusionThe BCG safety profile is consistent with expectations.The incidence of BCG AEFIs do not change significantly during 2005-2016.The most common rare adverse reactions are BCG lymphadenitis and local abscess.