Gardasil: Post-marketing study data

CDC and FDA published in the Journal of the American Medical Association data from the federal Vaccine Adverse Event Reporting System (VAERS) between June 1, 2006, and Dec. 31, 2008 that showed disproportional reporting of syncope and venous thromboembolism (VTE) associated with Gardasil. The authors noted that the significance of these findings should be tempered with the limitations of a passive reporting system, such as possible underreporting. The agencies also issued a joint statement saying that they "continue to find that Gardasil is a safe and effective vaccine" and they will continue to monitor its safety. During the timeframe, there were >23 million doses distributed in the U.S. and 12,424 reports of adverse events following immunization (AEFIs). Of those reports, 772 (6.2%) described serious AEFIs. ...