When reporting and evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established. Such data are subject to limitations of under-reporting, simultaneous administration of multiple vaccine antigens, reporting bias, and lack of incidence rates in unvaccinated comparison groups. VAERS data are from a passive surveillance system and represent unverified reports of adverse events temporally associated with one or more vaccines. form and mail the completed form with copies of supporting documents to New Hampshire Immunization Program, 29 Hazen Drive Concord, NH 03301, attn.: Registry. However, a comprehensive picture of vaccine-induced immune factors and pathways have not been systematically collected and analyzed. The incidence rate (how often events occur) cannot be calculated from VAERS data, because not all events are reported and the exact number of administered doses cannot be known. Vaccines stimulate various immune factors critical to protective immune responses. In addition, the National Childhood Vaccine Injury Act of 1986 (NCVIA) requires health care providers and vaccine manufacturers to report to the DHHS specific adverse events following the administration of those vaccines outlined in the Act.Ī balance must be struck in reducing the burden on voluntary reporters while providing enough data to produce necessary "signal flags" to trigger analysis of potential significant events and trends. The primary purpose for maintaining the database is to serve as an early warning or signaling system for adverse events not detected during pre-market testing. Although complete information greatly enhances the analysis of vaccine safety, in order to capture as many reports as possible, reports with less complete information will be included in the database. The information collected into the VAERS database comes from a wide array of sources, including patients and parents, state health agencies, pharmacies, health care providers, and the makers of the vaccines.
0 kommentar(er)
