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An Albuquerque mother has filed a lawsuit against the federal government alleging that her daughter was injured by the human papillomavirus vaccine Gardasil, according to the Albuquerque Journal. The suit was filed April 14 in the U.S. Court of Federal Claims in Washington.
Tracy Wolf said her daughter received the three-shot Gardasil series in 2007-08. Since then, Wolf said her daughter -- who was previously diagnosed with mild cerebral palsy and type-1 diabetes -- has been diagnosed with a seizure disorder, encephalitis, and other health problems. She also reported "significant, negative changes" in the behavior of her daughter, who is now 16 years old.
Wolf's suit lists as a defendant Kathleen Sebelius, secretary of the US Department of Health and Human Services. An HHS spokesperson could not say immediately whether the agency has received a copy of the lawsuit.
The Food and Drug Administration considers Gardasil safe and effective, and it says on its Web site that the vaccine's "benefits continue to outweigh its risks."
Last August, a report by FDA and CDC researchers used information from a federal database of adverse reactions to vaccines to further evaluate Gardasil. There were 12,424 reports of adverse events -- for 53.9 reports per 100,000 doses distributed. Of the events, 772 (6.2 percent) were described as serious, including 32 reports of death. Among cases where an autopsy was performed or death certificate existed, the deaths were attributed to factors other than the vaccine.
The complete report, "Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine," was published in the Journal of the American Medical Association.
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