Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Vaccine. 2013 Dec 9;31(51):6107-12. doi: 10.1016/j.vaccine.2013.09.066. Epub 2013 Oct 8.
BACKGROUND: Hypersensitivity disorders following vaccinations are a cause for concern. OBJECTIVE: To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines. DESIGN: A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines. SETTING/PATIENTS: US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010. MEASUREMENTS: Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event. RESULTS: Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 698 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine. LIMITATIONS: Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males. CONCLUSIONS: Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions.
背景：疫苗接种后的过敏反应是一个令人关注的问题。
目的：确定接种单价 2009 年甲型流感（H1N1）疫苗后，按年龄、性别和疫苗类型报告的过敏反应的类型和发生率。
设计：对单价 2009 年甲型流感（H1N1）疫苗接种后向疫苗不良事件报告系统（VAERS）报告的病例进行系统评价。
地点/患者：2009 年 10 月 1 日至 2010 年 5 月 31 日期间，美国接受疫苗的平民报告。
测量方法：护士和疫苗不良事件专家对年龄、性别、疫苗接种、诊断、临床体征和治疗进行了回顾。一个由 7 名过敏症专家组成的专家组审查了复杂的疾病和那些证据相互矛盾的病例，以确定事件的分类。
结果：在 1984 份报告中，1286 份与即刻过敏反应一致，698 份归因于焦虑反应、晕厥或其他疾病。20-59 岁人群中女性与男性的比例≥4:1，但10 岁以下儿童比例大致相等。111 份报告符合布莱顿合作组织过敏反应标准；仅有一半的人接受了初始治疗的肾上腺素。报告的过敏反应发生率为每百万疫苗剂量 10.7 例，活疫苗的发生率高出 2 倍。
局限性：漏报，特别是轻度事件的漏报，将导致对即刻过敏反应真实发生率的低估。仅在成年女性中选择性报告事件可能导致报告的男性发生率高于实际发生率。
结论：成年女性接种流感疫苗后发生过敏反应的风险可能高于男性。虽然 2009 年甲型流感（H1N1）疫苗接种后的过敏反应风险较低，但所有接种疫苗的诊所都应熟悉这些不良事件的治疗指南，包括在严重过敏反应早期使用肌肉内肾上腺素。
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