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Life Threatening? No
Write-up: Information has been received from a registered nurse concerning her 16 year old daughter with no known drug allergies and no medical history reported, who on 04-SEP-2007 was vaccinated intramuscularly with the second dose of Gardasil. Concomitant therapy included ACCUTANE. On 05-SEP-2007, the patient developed acute abdominal pain "within 24 hours of the vaccination," and was hospitalized for three days. The patient was diagnosed with mesenteric lymphadenitis and was treated with antibiotics and pain medications. Diagnostic laboratory studies performed, with no results reported, included: complete blood cell count, urine test, x-ray and computed axial tomography. On 09-SEP-2007 the patient recovered and was released from the hospital. No product quality complaint was involved. Mesenteric lymphadenitis was considered to be disabling and an other important medical event. Additional information has been requested. 5/2/08 Reviewed hospital medical records of 9/7-9/8/07. FINAL DX: non provided, no d/c summary available. Records reveal patient experienced fever, generalized body aches & achy abdominal pain x 1 day, worse on deep inspiration, better if lying down. Exam revealed tenderness RUQ & RLQ. Admitted for observation. GYN & surgical consults done. D/C to home.
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