Iskander John K, Miller Elaine R, Chen Robert T
Centers for Disease Control and Prevention, National Immunization Program, Epidemiology and Surveillance Division, Immunization Safety Branch, Atlanta, GA 30333, USA.
Pediatr Ann. 2004 Sep;33(9):599-606. doi: 10.3928/0090-4481-20040901-11.
The role of the health professional in supporting the national passive surveillance system is essential, as the first hint of a potential problem usually originates with the astute clinician who reports a case to the appropriate source. The investigation that resulted in the voluntary withdrawal of rotavirus vaccine was triggered by nine reports to VAERS of intussuception, eight of which had occurred within 1 week of the first dose of this vaccine. Health professionals have access to the most complete information related to adverse events experienced by their patients. Any index of suspicion that a serious event or death may be related to vaccination is reason for the health professional to submit a VAERS report. Determination of whether an event was caused by the vaccine is not a prerequisite for filing a VAERS report. When in doubt, providers should report to VAERS. VAERS solicits reports for all events temporally related to vaccination, some of which may be coincidental and some of which may merely indicate a change in the frequency of expected events. Post-marketing surveillance relies on health professionals to report suspicious events, thus improving the quality of reported data and contributing significantly to safeguarding public health. Recommendations for healthcare professionals to report to VAERS recently have been incorporated into the Standards for Pediatric Immunization Practices, which are endorsed by multiple professional organizations. Despite the limitations of spontaneous reports, VAERS provides vital information of clinical importance. The identification of signals in adverse event surveillance may initiate further investigation of potential problems in vaccine safety or efficacy, and facilitate subsequent dissemination of safety-related information to the scientific community and the public. This process begins with voluntary submission of reports of possible vaccine-associated events to VAERS by the informed and conscientious health professional.
卫生专业人员在支持国家被动监测系统方面的作用至关重要，因为潜在问题的首个线索通常源于敏锐的临床医生，他们会向适当的机构报告病例。导致轮状病毒疫苗自愿退市的调查是由向疫苗不良事件报告系统（VAERS）提交的9例肠套叠报告引发的，其中8例发生在首剂该疫苗接种后的1周内。卫生专业人员能够获取与患者所经历的不良事件相关的最完整信息。任何怀疑严重事件或死亡可能与疫苗接种有关的迹象，都是卫生专业人员提交VAERS报告的理由。确定事件是否由疫苗引起并非提交VAERS报告的先决条件。如有疑问，医疗服务提供者应向VAERS报告。VAERS征集所有与疫苗接种在时间上相关的事件报告，其中一些可能是巧合，一些可能仅仅表明预期事件发生频率的变化。上市后监测依赖卫生专业人员报告可疑事件，从而提高报告数据的质量，并为保障公众健康做出重大贡献。最近，针对医疗保健专业人员向VAERS报告的建议已纳入《儿科免疫实践标准》，该标准得到多个专业组织的认可。尽管自发报告存在局限性，但VAERS提供了具有临床重要性的关键信息。在不良事件监测中识别信号可能会启动对疫苗安全性或有效性潜在问题的进一步调查，并促进随后将与安全性相关的信息传播给科学界和公众。这个过程始于知情且尽责的卫生专业人员自愿向VAERS提交可能与疫苗相关事件的报告。
