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Life Threatening? No
Write-up: Information has been received from a physician, concerning a 14 year old female with no pertinent medical history, who on 22-NOV-2007 was vaccinated IM with the first dose, 0.5 ml, of GARDASIL (lot # 659435/1265U). Concomitant therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 11-JAN-2008, the patient had a physical, and had no symptoms. On 15-FEB-2008, she was seen in the office by another physician, with complaints of 2 weeks (onset 01-FEB-2008) of vomiting, diarrhea, low grade fevers and abdominal pain; the reporting physician also noted the patient had tiredness, and fainting spells. On 19-FEB-2008, an ultrasound of the abdomen and upper right quadrant to rule out gallstones, was negative. A computed axial tomography (CAT) scan to rule out a cyst. A complete blood count (CBC), and a urinalysis were normal. A laparoscopy of the pelvis was also normal. On 01-MAR-2008, the patient was hospitalized for severe abdominal pain and vomiting, and also complained of nausea and diarrhea. At discharge, on 07-MAR-2008, she was diagnosed with increased blood pressure, and was started on therapy with propanolol (not specified). An ultrasound indicated that both kidneys were enlarged. Although the CBC was normal, IV ROCEPHIN was started as a precautionary measure, and the patient was discharged on SUPRAX. On 10-MAR-2008 the patient was seen by the reporting physician and normal blood pressure, tender right and left flanks, and "on and off" flushing of the face. On 12-MAR-2008, she was seen again and flushing of the face was present, with blood pressure of 140/90 mmHg; a urine culture was negative. The patient was also seen by a nephrologist (date not specified), and "everything was normal, including blood pressure of 125/82." On 28-MAR-2008 the patient was lightheaded with a fever, and the wound from the laparoscopy was found to be infected; AUGMENTIN was initiated. On 02-APR-2008, the patient was pale and was admitted to the hospital with severe abdominal pain of the left flank with persistent vomiting. Intravenous (IV) fluids were started, and morphine injections for pain. A CBC, urinalysis, blood pressure and chest x-ray results were normal. There was tenderness at the left mid-abdominal area, but no enlargement of the kidneys. The pelvic ultrasound was normal. Although the peak and flow were normal, the physician felt that the patient had mild bronchospasms. On 07-APR-2008, the patient was ordered TYLENOL-CODEINE for abdominal pain, and nebulizer treatments for the mild bronchospasms. These symptoms were improving, and the patient was no longer vomiting. No further information was available. The physician considered the events to be significantly disabling. Additional information has been requested. 4/28/08-records received for DOS 4/3-4/4/08-DC DX: Abdominal pain of unknown etilogy. Presented to ED with servere abdominal pain which has been on and off since 4/1/08.
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