By: Marci Greenstein
Emily Tarsell thought she had enough information about Gardasil — a new vaccine marketed to girls to prevent certain types of cervical cancer — when she agreed to have her daughter receive the vaccine. But after her third and last injection of Gardasil, in 2008, Christina Tarsell, a previously healthy 21-year old, was dead.The depth of this family’s anguish at the death of their daughter can’t be conveyed. But after some time, and after realizing the possible link between Gardasil and her daughter’s death, Emily Tarsell decided she must try to find out if the vaccine was responsible. Thus began a real-life, real-time case study of how the Food and Drug Administration responds to citizens’ inquiries about possibly dangerous vaccines. Unfortunately, Tarsell would discover that the Food and Drug Administration’s system for monitoring adverse reactions to vaccines and informing the public about them was woefully inadequate.
The Tarsells are not the only family that has tried to navigate the FDA’s reporting system for vaccines, known as the Vaccine Adverse Event Reporting System or VAERS. The FDA has called VAERS the “front line of defense” in vaccine safety, while admitting that the system has serious limitations. First and foremost among these limitations is that VAERS is a “passive,” or voluntary, reporting system – which may explain why, according to FDA estimates, only 10% of adverse reactions to vaccines are reported. In addition, anyone can file a report with VAERS, from patients to pharmacists to physicians to vaccine manufacturers.
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