August 30, 2008
As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events.
Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of June 30, 2008, 20 deaths had been reported to VAERS. There was not a common pattern to the deaths that would suggest they were caused by the vaccine. In cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.
Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population. While FDA continues to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.
Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives which are known to increase the risk of clotting. Thromboembolic disorders as well as other medical events are being studied through the VSD in previously planned controlled studies. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.