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Life Threatening? No
Write-up: This spontaneous report was received from a medical assistant (patient''s mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she''d have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn''t know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn''t gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor''s office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren''t allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient''s condition got deteriorated and they couldn''t tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.
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