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Life Threatening? Yes
Write-up: Information has been received from a Physician Assistant concerning a 12 year old female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on 15-JUL-2008 was vaccinated with a first dose of GARDASIL (lot # 660387/1967U) 0.5ml (also reported mg) intramuscularly. Concomitant therapy included prednisone and PRILOSEC. In March 2009 the patient experienced difficulty breathing. She was taken to the hospital and "as per mom she was given an adult dose of morphine and went into respiratory failure". She later was unable to smile or move her face. Her cranial nerves were affected and she was seen by neurology. Later she was sent to a hospital for myasthenia gravis crisis. She had been hospitalized 3-4 times and she had received rehabilitation therapy. Most recently approximately on 16-JUN-2009, she had a "thymomectomy", secondary to myasthenia. The Physician Assistant and Physician did not feel the events were connected with GARDASIL. At the time of the report on 07-JUL-2009 the patient was recovering. There were many unspecified laboratories and diagnostics tests performed results not reported. She had not received any additional doses of GARDASIL. Difficulty breathing, respiratory failure, cranial nerves affected, given adult dose of morphine, and myasthenia gravis crisis were considered to be immediately life-threatening, disabling and other important medical events. "Given adult dose of morphine" was considered to be an overdose. Additional information has been requested. Medical records received DOS 7/15/08 to 7/7/09. Assessment: Myasthenia Gravis. Patient presents with continued fainting. Can''t raise arms, not able to cough, laugh, very weak. Falls, drops things. Redness and inflammation where spinal tap was done. Facial weakness. PMH: /ksk
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