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Life Threatening? No
Write-up: Information has been received from a physician concerning a female who developed "duodenal ulcer" after receiving GARDASIL (lot # not available). The patient had spoken to physician. At the time of the report, the patient''s status was unknown. Follow up information received from a physician concerning a 14 year old female with urinary tract infection. Exercise-induced asthma and no known drug allergies, who on 08-SEP-2009 was vaccinated with a dose of GARDASIL (lot # 662404/0312Y, IM) in the left arm at 2:15 p.m. Concomitant therapy included BACTRIM started on 08-SEP-2009 after GARDASIL vaccine was given for urinary tract infection. On 08-SEP-2009 the patient experienced nausea, myalgia, headache, dizziness lasting 6-8 weeks (especially the nausea), the patient was treated with zofran, ranitiding without relief. The patient was seen by gastroenterologist and had EGD done on 15-OCT-2009 which showed duodenal ulcer. Currently she continued to have nausea, headache despite being on NEXIUM. It was reported on 28-SEP-2009 from a medical record that she was in her normal state of health until three and a half weeks ago. Within hours of receiving GARDASIL, the patient began to have abdominal pain, nausea, dizziness, headaches, and body aches. The problems with abdominal pain and nausea had been constant for the past three and a half weeks. The patient stated that the nausea was constant, but she had had no vomiting. Her appetite had also been significantly less, she denies vertigo. The patient stated that her abdominal pain was worse after eating. She tried ZANTAC, which did not help with her pain or nausea. ZANTAC made her more dizzy. The patient also had persisting intermittent headaches and dizziness. Her body aches had resolved. The patient reported that her stools were soft and daily. She denied any history of constipation. Current medications included ALBUTEROL as needed. The patient would undergo a colon clean-out, start daily stool softener therapy, bowel retraining, and increased dietary fiber. For her colon clean-out she would start DULCOLAX. She would take one DULCOLAX 5 mg tablet followed by ten capfuls of MIRALAX and 32 ounces of GATORADE, then another DULCOLAX tablet. Following a successful clean-out, she would start one capful of MIRALAX daily, she would began retraining by sitting on the toilet following breakfast and dinner each day and follow a handout to help add fiber to her diet. It was reported on 31-MAR-2010 from a medical record that the patient was seen in office for functional dyspepsia and functional abdominal pain. EGD was repeated which showed a normal esophagus, stomach, and 2nd portion duodenum. Biopsy from the Bulb of duodenum showed some inflammation still in area where previous erosion was seen. The inflammation was non specific, so a Food allergy panel and Celiac panel were done, which were normal. She treated empically for SBBO with FLAGYL 250mg BID for 7 days. She got no better. She remained on NEXIUM 40mg twice a day. For Abdominal Pain, the patient would start MSD tabs at bedtime for 2 weeks, then increased by 1 tablet once a week to maximum 5 tablets at bedtime. The patient would continue NEXIUM twice a day. She would continue to follow up with the physician. "Duodenal ulcer", headache, myalgia, nausea, body ache and dizziness were considered to be disabling and other important medical events by the reporter. Additional information has been requested.
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