Division of Pediatric Infectious Diseases, Stanford University Medical Center, Stanford, CA, USA.
Pediatr Infect Dis J. 2013 Feb;32(2):163-8. doi: 10.1097/INF.0b013e318271b90a.
BACKGROUND: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013. METHODS: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination. Selected reports were referred to the Centers for Disease Control and Prevention's Clinical Immunization Safety Assessment network for additional review. We assessed causality using modified World Health Organization criteria. RESULTS: There were 3,928 reports of AEFI in children younger than age 18 years after 2009 H1N1 vaccination received by January 31, 2010. Of these, 214 (5.4%) were classified as serious nonfatal and 109 were referred to Clinical Immunization Safety Assessment for further evaluation. Ninety-nine (91%) had sufficient initial information to begin investigation and are described here. The mean age was 8 years (range, 6 months-17 years) and 38% were female. Median number of days between vaccination and symptom onset was 2 (range, -11 days to +41 days). Receipt of inactivated, live attenuated, or unknown type of 2009 H1N1 vaccines was reported by 68, 26 and 5 cases, respectively. Serious AEFI were categorized as neurologic events in 47 cases, as hypersensitivity in 15 cases and as respiratory events in 10 cases. At the time of evaluation, recovery was described as complete (61), partial (16), no improvement (1), or unknown (21). Causality assessment yielded the following likelihood of association with 2009 H1N1 vaccination: 8 definitely; 8 probably; 21 possibly; 43 unlikely; 17 unrelated; and 2 unclassifiable. CONCLUSIONS: Most AEFI in children evaluated were not causally related to vaccine and resolved without sequelae. Detailed clinical assessment of individual serious AEFI can provide reassurance of vaccine safety.
背景：2009 年至 2013 年 H1N1 流感大流行期间，美国批准并使用了单价 2009 年 H1N1 流感疫苗。
方法：疫苗不良事件报告系统（VAERS）收到了接种 H1N1 疫苗后的不良事件（AEFI）报告。选择的报告被提交给疾病控制与预防中心的临床免疫安全评估网络进行进一步审查。我们使用改良的世界卫生组织标准评估因果关系。
结果：截至 2010 年 1 月 31 日，VAERS 收到了 3928 例年龄在 18 岁以下儿童接种 2009 年 H1N1 疫苗后的 AEFI 报告。其中，214 例（5.4%）被归类为非致命严重病例，109 例被提交给临床免疫安全评估以进一步评估。99 例（91%）有足够的初始信息开始调查，现对此进行描述。平均年龄为 8 岁（范围：6 个月至 17 岁），女性占 38%。接种疫苗和症状出现之间的中位数天数为 2 天（范围：-11 天至+41 天）。分别有 68、26 和 5 例报告接种了灭活、减毒活或未知类型的 2009 年 H1N1 疫苗。严重 AEFI 分为 47 例神经事件、15 例过敏反应和 10 例呼吸事件。在评估时，恢复情况描述为完全（61 例）、部分（16 例）、无改善（1 例）或未知（21 例）。因果关系评估得出以下与 2009 年 H1N1 疫苗接种的关联可能性：8 例肯定；8 例很可能；21 例可能；43 例不太可能；17 例无关；2 例无法分类。
结论：评估的大多数儿童 AEFI 与疫苗无因果关系，并在没有后遗症的情况下痊愈。对个别严重 AEFI 的详细临床评估可以提供疫苗安全性的保证。
Pediatr Infect Dis J. 2013-2
Commun Dis Intell Q Rep. 2010-9
MMWR Morb Mortal Wkly Rep. 2009-12-11
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