Abstract

Objective To evaluate the safety of hepatitis B vaccine in Zhejiang Province from 2012 to 2016. Methods The data of adverse events following immunization (AEFI) for hepatitis B vaccine in Zhejiang Province during 2012 to 2016 were collected through the AEFI information system, and were analyzed by descriptive epidemiological methods. Results A total of 1 051 AEFI cases were reported in Zhejiang Province in 2012-2016, and the estimated incidence rate was 9.61 per 100 000 doses, which showed an increasing trend year by year (χ2trend=432.45, P<0.01) . A total of 110 cases had rare vaccine reactions with the incidence rate of 1.01 per 100 000 doses. Twenty-five cases had severe AEFI with the incidence rate of 0.23 per 100 000 doses, and 19 cases were coincidental diseases among whom 10 cases died. In all AEFIs, male cases were more than female ones (1.23∶1) , and most cases were under 1 year old (915 cases, 87.06%) . The cases were often reported from May to August (43.20%) and in Hangzhou (352 cases) . Hepatitis B vaccine adverse reactions mainly happened after the third dose (671 cases, 63.84%) or within 1 day (931 cases, 88.58%) after vaccination. The main symptoms of common vaccine reactions were fever, local swelling and indurations. The main diagnoses of rare vaccine reactions were anaphylactic rashes (68 cases, 0.62 per 100 000 doses) with good prognosis. Conclusions The hepatitis B vaccine in Zhejiang Province is safe. However, we should pay more attention to the incidence, diagnosis and treatment of coincidental death reaction, and improve AEFI surveillance of hepatitis B vaccine. Key words: Hepatitis B vaccines; Safety; Analysis

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