活体减弱型流感疫苗后昏迷:向疫苗不良事件报告系统 (2003-2024) 报告
Emily Jane Woo1, Elaine R Miller2, Erin Stroud2
1Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20903, United States of America.
Vaccine
|September 6, 2024
概括
鼻内流感疫苗 (LAIV) 接种后的血管是罕见的,每百万剂量约为0.4次. 大多数病例涉及青少年,有些人导致伤害,突出了疫苗接种后观察的必要性.
科学领域:
- 免疫学 免疫学 免疫学
- 公共卫生 公共卫生
- 神经学 神经学
背景情况:
- 血管 (昏) 可能是由各种刺激引发的,包括像疫苗接种这样的医疗程序.
- 在接种疫苗后,特别是在青少年中,有报告说过昏,并可能导致伤害.
研究的目的:
- 总结了使用疫苗不良事件报告系统 (VAERS) 接种活体减弱型流感疫苗,鼻内 (LAIV) 后昏的报告.
- 评估LAIV后昏迷的发生率和特征,并确定潜在的受伤风险因素.
主要方法:
- 对VAERS数据的回顾性审查,对与美国作为唯一疫苗的LAIV相关的昏迷报告.
- 对人口统计数据,昏迷时间,受伤报告和医疗结果的分析.
主要成果:
- 在2003年6月至2024年5月期间,LAIV后有50起昏迷报告,其中46%在10-19岁的人群中.
- 30%的病例导致伤害,主要是跌倒造成的头部或面部创伤.
- 昏迷通常发生在接种疫苗后15分钟内,52%的患者没有等待推的15分钟观察.
结论:
- 在LAIV后出现昏迷是罕见的,报告率约为每百万剂量0.4个.
- 青少年受到了不成比例的影响,疫苗接种后不充分的观察可能会增加受伤风险.
- 关于LAIV的管理和疫苗接种后护理的知情决策对于预防昏睡相关的伤害至关重要.
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