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Life Threatening? No
Write-up: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history or drug allergies who on 21-MAY-2007, was vaccinated IM with a 0.5ml dose of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified) ("MERCET"). On 23-MAY-2007, the patient died suddenly. The cause of death was unknown. Unspecified medical attention was sought. Laboratory diagnostic studies included an autopsy which showed no findings. No product quality complaint was involved. The reporter stated that Gardasil did not cause the patient''s death. Additional information is not expected. 7/2/08-records received-Adverse effect of drugs.Toxicology survey findings:urine positive for methadone, benzodiazepines, benzoylecgonine (from cocaine), cannabinoids, nicotine, diphenhydramine and naproxen.
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