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Life Threatening? No
Write-up: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse and from the emergency room medical record concerning a 23 year old female hair stylist with irregular menstruation, attention deficit/hyperactivity disorder and a history of anaemia, Crohn''s disease and infectious mononucleosis who on 08-FEB-2007, at 14:15 PM was vaccinated IM in to right deltoid with a first dose of Gardasil lot #654702/0011U. She received the second dose of Gardasil on an unspecified date. Concomitant therapy included azathioprine (IMURAN (azathioprine)), ethinyl estradiol (+) levonorgestrel (SEASONALE) and balsalazide disodium (COLAZAL). On 08-FEB-2007 later that day patient experienced nausea and vomiting. She was seen in the emergency room (ER) that night. She was treated with an unnamed antinausea medication and intravenous fluids. She was sent home later. She had no adverse symptoms after the second injection. The patient recovered. The reporter felt that getting unnamed antinausea medication and intravenous fluids was to prevent patient from being serious and considered this as a serious other medical event. Additional information has been requested. In the follow up it was indicated that on 08-FEB-2007 patient began experiencing nausea and vomiting approximately 1/2 hour after receiving her first dose of GARDASIL was unable to hold down any food, fluids through the afternoon or evening. She went to the emergency room (ER) for evaluation and Intravenous (IV) fluids. ER record indicated she wen to the ER complained pain in her back, legs and abdomen. She had nausea, vomiting, fever and she was pale and weak. The pain characteristic was cramping, sharp and constant. She also had bodyache and myalgia, she was treated in the ER with TYLENOL gram by mouth, ANTIVERT 12.5 milligram intravenous (IV), TORADOL 30 milligram IV, ROCEPHIN 2 gram IV and 2 litters of normal saline solution (NSS) IV. Initially patient went to the ER her temperature measurement was 102.4 F, pulse was 135, respiration was 20 and blood pressure was 88/52. Patient''s blood pressure measurement was 88/55, heart rate was 108 and respiration was 19 at the time of discharge from the ER. Pulse Oximetry was 100% on room air (RA). On 09-FEB-2007 the patient recovered. On an unspecified day she received the second dose of GARDASIL and had no adverse symptoms. The reporter no longer considered the events to be other important medical events. Additional information is not expected.
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