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Life Threatening? No
Write-up: Information has been received from a physician concerning a 23 year old female with a sulfonamide and penicillin allergy and no other pertinent medical history who on an unspecified date received her second dose of Gardasil. Subsequently, she had joint pain. She was seen by a rheumatologist, but unspecified tests came back negative. Subsequently, she recovered. on 28-AUG-2007 the patient was vaccinated with her third dose of Gardasil, 0.5 mL (Lot # 658556/1060U). Concomitant therapy included lamotrigine (LAMICTAL) and varenicline tartrate (CHANTIX). On 29-AUG-2007 after receiving her third dose of Gardasil, the patient complained of generalized joint and muscle pain. The pain was so strong that she could not walk. She had to stay in bed and was not able to go to work. The physician noted the patient had no problems with the first dose of Gardasil and only had joint pain after second dose and after the third dose, pain reappeared all over her body. The patient called the physician and sought medical attention. Patient Quality Complaints (PQC) were not involved. The physician considered generalized joint and muscle pain to be disabling because the patient could not walk. Additional information has been requested. In follow-up it was reported by the physician, that the patient a 23 year old, female with a sulfonamide and penicillin allergy and no pertinent medical history and no illness at the time of vaccination who on 28-AUG-2007 was vaccinated intramuscularly into the left arm with the third dose of GARDASIL, (Lot # 658556/1060U). It was reported that on 29-AUG-2007, the patient at first had joint pain in both hands and then generalized muscle pain and joint pain throughout the whole body. It was reported that the patient felt better and recovered on 31-AUG-2007. Additional information has been requested.
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