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目的了解2009年甲型H1N1流行性感冒(甲流)大流行期间,上海市大规模接种甲流病毒裂解无佐剂疫苗的安全性。方法对2009年10～12月上海市接种甲流疫苗的情况,不良反应发生率、程度和转归等进行调查分析。结果上海市2009年10月15日～12月31日,共有1373496人接种了甲流疫苗,报告疑似预防接种异常反应(Adverse Events Folowing Immunization,AEFI)620人,AEFI报告发生率为45.14/10万人,95%可信区间:42/10万人～49/10万人。其中一般反应531人,占85%,报告发生率38.66/10万人,以发热为主要表现;异常反应37人,报告发生率2.69/10万人,临床表现主要是过敏性反应。多数不良反应于发生后48h内,可自愈消退或治疗后痊愈。无严重不良反应发生。结论接种甲流疫苗后不良反应报告发生率低,且多为症状轻微的一般反应,无严重不良反应,比较安全。
Objective To understand the safety of large-scale influenza A virus-free adjuvanted vaccine in Shanghai during the pandemic influenza A (H1N1) epidemic in 2009. Methods The case of Shanghai A flu vaccine, the incidence, degree and outcome of adverse reactions in Shanghai from October to December in 2009 were investigated. Results From October 15, 2009 to December 31, 2009, a total of 1373496 people were vaccinated with H1N1 vaccine, reporting 620 suspected AEFIs (AEFI) and the AEFI rate was 45.14 / 100 000 Person, 95% confidence interval: 42/10 million to 49/10 million. The general reaction was 531, accounting for 85%. The reported incidence was 38.66 / 100000, with fever as the main manifestation. There were 37 abnormal reactions with a reported incidence of 2.69 per 100 000. The clinical manifestations were mainly allergic reaction. The majority of adverse reactions within 48h after onset, can be self-healing subsided or cured after treatment. No serious adverse reactions occurred. Conclusion The incidence of adverse reactions after receiving Influenza A vaccines is low, and most of them are mild reactions with no obvious adverse reactions and are safe.