Singleton J A, Lloyd J C, Mootrey G T, Salive M E, Chen R T
Vaccine Safety and Development Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Vaccine. 1999 Jul 16;17(22):2908-17. doi: 10.1016/s0264-410x(99)00132-2.
We evaluated the Vaccine Adverse Event Reporting System (VAERS), the spontaneous reporting system for vaccine-associated adverse events in the United States, as a public health surveillance system, using evaluation guidelines from the Centers for Disease Control and Prevention. We found that VAERS is simple for reporters to use, flexible by design and its data are available in a timely fashion. The predictive value positive for one severe event is known to be high, but for most events is unknown. The acceptability, sensitivity and representativeness of VAERS are unknown. The study of vaccine safety is complicated by underreporting, erroneous reporting, frequent multiple exposures and multiple outcomes.
我们依据美国疾病控制与预防中心的评估指南，将美国疫苗不良事件报告系统（VAERS）作为一个公共卫生监测系统，对其进行了评估。我们发现，VAERS对报告者来说使用简便，设计灵活，数据可得及时。已知其对某一严重事件的阳性预测值较高，但对大多数事件而言尚不清楚。VAERS的可接受性、敏感性和代表性均不明确。疫苗安全性研究因报告不足、错误报告、频繁的多重暴露和多种结果而变得复杂。
