Ball R, Braun M M, Mootrey G T
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852, USA.
Clin Infect Dis. 2001 May 1;32(9):1273-80. doi: 10.1086/319982. Epub 2001 Apr 3.
Recent recommendations by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may lead to the increased use of the meningococcal polysaccharide vaccine. The Vaccine Adverse Event Reporting System (VAERS) is useful for the detection of previously unrecognized reactions and for the monitoring of known reactions. Limitations of VAERS include underreporting and the inability to establish a causal relationship between vaccination and adverse events in most cases. From July 1990 through 31 October 1999, 110 adverse events were reported after receipt of meningococcal vaccine alone. Thirteen (12%) were serious, including 6 injection site reactions, 3 allergic reactions, 1 case of Guillain-Barré syndrome, and 3 miscellaneous events. Fever (30%), headache (17%), dizziness (15%), injection site hypersensitivity (13%), urticaria (12%), and paresthesia (10%) were among the most common events reported. Fever and injection site and allergic reactions are most likely causally linked to the vaccine. That there were few reports of serious adverse events, with >6 million doses having been distributed, and no clear signal of a previously unrecognized serious reaction is reassuring with regard to the safety of meningococcal vaccine.
美国疾病控制与预防中心免疫实践咨询委员会最近的建议可能会导致脑膜炎球菌多糖疫苗的使用增加。疫苗不良事件报告系统（VAERS）有助于发现以前未被认识的反应，并监测已知反应。VAERS的局限性包括报告不足，以及在大多数情况下无法确定疫苗接种与不良事件之间的因果关系。从1990年7月到1999年10月31日，仅在接种脑膜炎球菌疫苗后报告了110起不良事件。其中13起（12%）为严重事件，包括6起注射部位反应、3起过敏反应、1例格林-巴利综合征和3起其他事件。报告的最常见事件包括发热（30%）、头痛（17%）、头晕（15%）、注射部位超敏反应（13%）、荨麻疹（12%）和感觉异常（10%）。发热以及注射部位和过敏反应很可能与疫苗存在因果关系。已分发了超过600万剂疫苗，但严重不良事件报告很少，且没有之前未被认识的严重反应的明确迹象，这让人对脑膜炎球菌疫苗的安全性感到放心。
