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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from a physician on 24-OCT-2011 and medically confirmed. A 15-year-old female patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in the arm on 25-OCT-2010. On 03-NOV-2010, the patient was seen due to pain in calf and purpuric spots on both legs. The patient was not athletic and had been participating orienterring race the day before, and the physician thought it was a muscle strain. Blood count and differential white count was prescribed. On 04-NOV-2010, the patient experienced headaches and felt drowsy while being in classroom. Her mother picked her up and she remained at home. In the afternoon, her mother had difficulties waking her up. The patient was slow and had difficulties moving. EMU (Emergency Mobile Unit) was called and the patient was led to hospital on 04-NOV-2010. On admission diffuse hemorrhage cerebral and acute leukemia were discovered. White blood cells count was at 500 000. Hemoglobin was at 9, 5 and platelets at 51000. The patient was transferred to intensive care unit where her Glasgow coma scale quickly fell down from 13 to 8. Hemoglobin was at 7, platelets at 45000, white blood cells count at 426000. There was no adenopathy, no tumor. Liver and spleen were normal. CT scan showed numerous effusions. During the night, she experienced an episode of hypertension treated with EUPRESSYL and then hypotension and mydriasis. The patient died on 06-NOV-2010. To be noted that no clinical sign or symptom had been noticed prior to this episode. The patient used to be in good health and was not very often sick. She had received the first dose of GARDASIL via intramuscular route in the arm on 25-AUG-2010 which had been well tolerated. To be noted that the patient''s mother felt guilty and needed to "hold onto" something, including the vaccine. The hospital staff told her that there was no link between the vaccine and the events. Psychological follow-up was still ongoing. It was noteworthy that the general practitioner did not report any link with vaccination. Other business partner numbers included: E2011-06493. No further information is available.
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