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Life Threatening? No
Write-up: Information has been received from an investigator concerning a 12 year old male with migraine headaches who entered a study. On approx 6/16/06 and 8/16/06 and on 11/16/06 at 16:15 the pt was vaccinated with a first, second and third dose of HPV vaccine. On 11/17/06 the pt woke up at 6:40 and went to the bathroom and he reported that he had trouble walking. He returned to bed. The pts father woke him up at 7:45 and noted that he had a fever of 101.3F. the pt stated that his arms and legs were heavy feeling and he didn''t think he could walk. the pt experienced muscle weakness. The pts parents call the physician and were advised to take the pt to the ER. The pt went to the ER via ambulance. When the pt arrived the ER his temp was 99.5F (Pt was treated with Advil at home. It was noted that the pts neurosigns were normal and the pt reported to have a headache but refused Imetrex. the pt was discharged and no further tests were done. On 11/17/06 the pt recovered. The reporting investigator felt that muscle weakness was related to study therapy. Muscle weakness was considered to be an other important medical event (OMIC).
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