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Vaccine Safety Forum: Summaries of Two Workshops
A consumer representative suggested that, as part of the legal requirement for physicians to report serious adverse events following vaccination, failing to report such events should result in penalties. Parallel to mandatory vaccination laws that keep children out of school if they are not vaccinated, such laws could prevent physicians from administering vaccines if they neglect to report hospitalizations, deaths, and injuries following vaccination.
Improving the Quality of Information in VAERS
A frequent problem encountered with VAERS is misclassification. An FDA representative pointed out that serious events can be misclassified as nonserious if the reporter does not recognize the seriousness of the event or if a serious event is treated on an outpatient basis. (The current definition of a ''serious" event requires that the individual be hospitalized.) He indicated that he has seen reports of paralyzing disorders such as Guillain-Barré syndrome and Bell's palsy incorrectly labeled as nonserious.
Another criticism of VAERS is that the description of the adverse event is often inaccurate—that is, the reporter inaccurately labels the adverse event. An FDA study found that for nearly one-quarter of the fatalities reported to VAERS, the final cause of death was significantly different from the cause initially reported (Wise, 1994). A CDC study, however, found that nearly 90 percent of the reports of Guillain-Barré syndrome in VAERS were accurate (Haber et al., 1994).
To improve the accuracy of the information reported to VAERS, several speakers or participants suggested developing more standardized case definitions for evaluating the adverse events reported. Under the direction of CDC and FDA, the VAERS staff is currently undertaking several efforts to improve the quality of the data. Among these are improving the automated screening procedures designed to detect reporting or transcribing errors in VAERS data; improving-the consistency in entering, tracking, and analyzing VAERS data; and improving the detection of duplicate VAERS reports entered into the database. CDC, FDA, and Health Resources and Services Administration Division of Vaccine Injury Compensation are establishing a panel of medical experts to provide advice on analyses of difficult cases and are continuing to conduct studies to evaluate the biases present in the system, examining such issues as reporting delays and how they affect the analysis and validity of the data.
To facilitate the VAERS reporting process and to increase the likelihood that physicians will complete VAERS forms, a vaccine manufacturer's representative suggested that the form might be made more specific. Rather than