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Gardasil Side Effect Reports Included 28 Deaths, Group Says

Jun 25, 2009 | Parker Waichman Alonso LLP

A conservative advocacy group is charging that more than 2 dozen women and girls died in 2008 after receiving Gardasil injections.   According to a press release issued by Judicial Watch, there have been a total of 47 deaths linked to Gardasil since it was brought to market in 2006.

Gardasil is a vaccination that  prevents some forms of the Human Papillomavirus (HPV) that cause  cervical cancer.  Gardasil has been controversial because of attempts by Merck & Co. to make it mandatory, and because of continuing questions about its safety.

Earlier this month, the Food & Drug Administration (FDA) announced that the Gardasil label  had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to   roughly 13% of Gardasil side effects reported to Vaccine Adverse Event Reporting System (VAERS) describe fainting.

Judicial Watch says it  has obtained records from the FDA documenting 28 deaths in 2008 associated with Gardasil, up from 19 deaths in 2007. Of the 47  deaths reported since 2006,  Judicial Watch said 41 occurred within a month of receiving the vaccine, and of those 17 were within two weeks of receiving the vaccine. In most of the deaths the cause is still unknown.

According to the group,  the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening,"  Judicial Watch said.  The group said it obtained the data from  VAERS.

Since last June, 235 cases detailed permanent disability. There were also 29 new cases of Guillain-Barre Syndrome, and 147 cases of "spontaneous abortions," or miscarriages, when the vaccine was given to pregnant women, Judicial Watch said.

Judicial Watch also documented 62 cases of Gardasil recipients who developed warts after receiving the vaccine.  In additional to reports of genital warts, there were 21 reports of girls developing warts on other areas of the body, including face, hands and feet, and in one case, "all over her body."