SOURCE: Judicial Watch

June 30, 2008 12:53 ET

Judicial Watch Uncovers New FDA Records Detailing 10 New Deaths & 140 "Serious" Adverse Events Related to Gardasil

Watchdog Publishes New Special Report Examining 8,864 Adverse Event Reports Detailing Safety Concerns

WASHINGTON, DC--(Marketwire - June 30, 2008) - Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released a report based on new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reactions include 10 deaths since September, 2007. (The total number of death reports is at least 18 and as many as 20.) The FDA also produced 140 "serious" reports (27 of which were categorized as "life threatening"), 10 spontaneous abortions and six cases of Guillain-Barre Syndrome -- all since January 2008. Adverse reports excerpts include:

--  Information has been received... concerning a 20 year old female with
    no medical history reported, who on 01-APR-2008 was vaccinated with a dose
    of Gardasil... The patient died four days after... patient sought
    unspecified medical attention.  An autopsy was performed which ruled out
    suicide and anything suspicious. The cause of death is currently unknown.
    VAERS ID: 310262-1 (D)
    
--  Information has been received... concerning a 23-year-old female...
    who on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil... the
    patient experienced anaphylactic shock 2 minutes after vaccination
    characterized by a brief loss of consciousness... respiratory arrest, eyes
    rolled upwards, blurred vision and greyish skin tone... Anaphylactic shock
    was considered to be immediately life-threatening. VAERS ID: 304739-1 (S)
    
--  Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate
    post-injection reaction... Pt [patient, 14-year-old female] received
    vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec
    grand mal seizure then regained consciousness. [Blood pressure] after
    seizure 60/40 pale clammy skin. [Patient] had bit her tongue and had foam
    around her mouth. VAERS ID: 305259-1 (S)
    
--  Information has been received from a physician concerning a female
    patient who on an unknown date was vaccinated with a dose of Gardasil.
    Subsequently, the patient experienced a coma and is now paralyzed.  At the
    time of this report, the patient's outcome was unknown. VAERS ID: 303188-1
    

"Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children," stated Judicial Watch President Tom Fitton.

Judicial Watch had previously obtained 3,461 reports relating to Gardasil. On June 10, 2008, Judicial Watch received a compact disk from the FDA with a new total of 8,864 Vaccine Adverse Event Reporting System (VAERS) records. These documents and the new Judicial Watch report, titled "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 at www.judicialwatch.org.

Contact Information

  • Contact:
    Judicial Watch
    Jill Farrell
    202-646-5188