Judicial Watch Uncovers FDA Records Detailing 16 New Deaths Tied to Gardasil

Records Document 3,589 Adverse Reactions Related to Gardasil between May 2009 and September 2010, Including 213 Cases Resulting in Permanent Disability

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Washington, DC -- September 28, 2010

Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it has received new documents from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act (FOIA), detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reactions include 16 new deaths (including four suicides) between May 2009 and September 2010. The FDA also produced 789 “serious” reports, with 213 cases resulting in permanent disability and 25 resulting in a diagnosis of Guillain Barre Syndrome.

Adverse report excerpts include:

• A nineteen year old girl with no medical history except occasional cases bronchitis received Gardasil and in 53 days, had “Headache, Nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest plain, severe cramps.” She experienced an Acute Cardiac Arrhythmia. Attempts to resuscitate her resulted in a sternal fracture, but were unsuccessful and the patient died. — V. 356938
• A thirteen year old girl was vaccinated on July 17th, 2009. Ten days later, she developed a fever and was treated. However, “the patient did not recover and was admitted to the hospital on [August 8th]…She developed dyspnoea and went into a coma…she expired [that day] at around 9:00 pm. The cause of death was determined as ‘death due to viral fever.’ … This event occurred after 23 days of receiving first dose of Gardasil. — V. 380081
• Thirteen days after vaccination, a ten year old girl developed “progressive loss of strength in lower and upper extremities almost totally…Nerve conduction studies [showed Guillain Barre Syndrome].” Case was “considered to be immediately life-threatening.” — V. 339375

One mother of a 13-year old girl who died 37 days after receiving the vaccination noted in a report: “I first declined getting her the vaccination but her doctor ensured me that it was safe…” After her daughter complained of a severe headache, no feeling in her foot and a tingling feeling in her leg, a doctor’s appointment was set for October 23, 2009. “My daughter never made it to Oct[ober] 23rd, which is also her birthday,” the mother noted. “She passed on Oct[ober] 17th, I found her cold unresponsive in her room at 7am....”

“To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public health authorities may be asleep at the switch,” said Judicial Watch President Tom Fitton. “In the meantime, the public relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children.”

In 2008, Judicial Watch launched an investigation of the FDA's reporting on adverse reactions to vaccinations for HPV. All previous FDA documents uncovered by Judicial Watch, as well as a Judicial Watch special report, entitled “Examining the FDA’s HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment,” are available.