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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on 11-JAN-2007 was vaccinated with the first dose, 0.5ml, of Gardasil, with no adverse events reported, and on 08-MAR-2007 was vaccinated with the second dose, 0.5ml, of Gardasil. There was no concomitant medication. On 08-APR-2007, the patient had experienced "extreme leg and back pain" and was diagnosed with acute transverse myelitis; she was hospitalized. The duration of hospitalization was not known. At the time of this report, the patient had not recovered from the acute transverse myelitis. Additional information has been requested. 6/19/07 Received PCP medical records which included vax records w/lot & dose #s. VAERS database updated w/same. ALso included was hospital d/c summary which reveals patient admitted 4/17-4/20/07 with severe LE pain which had progressively worsened. Seen by PCP who sent to neurologist prior to admit . Admitted for high dose steroids & close observation. Improved dramatically & d/c to home w/PCP & neuro f/u. Seen by neuro in f/u on 4/23/07 being transported by ambulance on a gurney due to total paralysis of both LEs. Also had severe depression. 5/18/07 w/only partial recovery. Continued to have severe low back & LE pain despite fentanyl patch & PT. Was unable to ambulate & was w/c bound. Exam revealed severe flaccid hypotonic muscle weakness of LEs w/hyperreflexia. Bladder & bowel function were intact. Patch increased & was to continue PT. 7/3/07 Received hospital medical records which reveal patient experienced severe LE pain which had progressively worsened. Admitted 4/17-4/20/07 for IV steroids & pain management. Patient had URI w/sore throat & fever approx 3-4 wks prior to admit treated w/antibiotics. Then developed back pain which worsened & LEs also became numb. Seen by PCP who consulted neurosurgeon & MRI was done which was neg. Patient continued to worsen & was seen by neurologist who dx w/transverse myelitis & admitted to hospital. FINAL DX: Transverse Myelitis.
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