It took a Freedom of Information Act request for Judicial Watch to acquire documents showing that the Food and Drug Administration (FDA) had produced 789 reports of "serious" adverse reactions -- including 16 deaths and 213 permanent disabilities - among young girls who had received Gardasil, the vaccine for human papillomavirus (HPV).
FDA adverse reaction reports acquired by Judicial Watch include:
- A 19-year-old girl with no serious medical history who suffered headache, nausea, dizziness, chilling, tiredness, shortness of breath, chest plain and severe cramps, and died of Acute Cardiac Arrhythmia within 53 days of receiving Gardasil.
- A 13-year-old girl who died of "viral fever" 23 days after receiving her first dose of Gardasil.
"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 a press release. "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."
The FDA approved Gardasil on June 8, 2006 for use as a vaccine against certain types of human papillomavirus (HPV) which is believed to be the primary cause of cervical cancer in women and genital warts in men.