Last week, a Texas woman named Michelle Kimzey made headlines when she suggested that Gardasil, the Merck vaccine for human papillomavirus (HPV), had caused her 14-year-old daughter to develop epilepsy. Kimzey claimed that she found some 5,000 other reports of adverse side effects in the federal government’s vaccine safety surveillance database, the Vaccine Adverse Event Reporting System (VAERS).
This is not the first time VAERS has been invoked in news stories about the safety of the HPV vaccine. Last year, the National Vaccine Information Center published an analysis of VAERS data suggesting that Gardasil could cause serious side-effects including the development of an autoimmune disorder, Guillain-Barre Syndrome (GBS). While VAERS is a valuable tool for monitoring vaccine safety—both the Centers for Disease control and Prevention (CDC) and the Food and Drug Administration (FDA) analyze information in the database—the reports can cause alarm when taken out of context.
The public should know that VAERS collects only unverified reports of health events. The CDC and FDA encourage parents, vaccine manufactures, health care providers and others to report all adverse events following vaccinations, regardless of whether the vaccination is the suspected cause. Thus some of the purported vaccine side-effects actually reflect underlying diseases or conditions completely unrelated to the vaccination. VAERS does not keep tabs on groups who have not received vaccinations, so there are no control groups to compare incidence rates of various health events.
Given these issues perhaps the government should revamp the database to prevent the VAERS reports from being misconstrued as verified cases of vaccine deaths and complications. What do you think?