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Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes
Write-up: Information has been received from a Foreign Authority (reference number DK-DKMA-20090203) concerning a 15 year old female patient who was vaccinated intramuscularly with the first dose of GARDASIL (lot # 1941U, batch # NJ01850, site of administration not reported) on 23-DEC-2008. It was reported that the patient experienced rhabdomyosarcoma on 25-Dec-2008. She was diagnosed with rhabdomyosarcoma (date of diagnose not reported). The sarcoma presumably had its origin in the patient''s uterus (not confirmed). The patient was hospitalized (date not reported) and placed in coma (date not specified) at the hospital intensive unit. The patient''s abdomen was opened due to an inoperable, rapidly growing tumor which at the time of acute operation had grown rapidly to the size of a full term pregnancy (date not specified). The patient received chemotherapy (onset date not specified) and experienced complications in form of uraemia and bleeding (not further specified). The course of the disease was reported as unexpectedly fast and aggressive. Initially, before the expansion of the abdomen, the adverse event was interpreted as appendicitis. At the time of report to the Health Authorities the condition of the patient was stable and she was scheduled to be taken out of coma the next day (date not reported). It was reported that the patient was healthy and did not suffer from any known diseases at the time of vaccination. The patient received no concomitant vaccinations or medication. At the time of report the patient had not recovered. Other business partner numbers include: E2009-01070. No further information is available.
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