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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a physician concerning a 17 year old female patient with Gilbert''s syndrome (benign syndrome with normal variance) and no known drug allergies who received GARDASIL series (first dose on 10-Sep-2007, lot # 658554/0928U; second dose on 26-Nov-2007, lot # 659439/1267U; third dose on 29-Apr-2008, lot # 659964/1978U). There was no concomitant medication. In approximately February 2011 ("about 1 1/2 months before diagnosis date of 31-MAR-2011"), the patient experienced weakness, trembling and pain in her legs. So she went to the emergency department at a hospital. The symptoms had been processing to her arms. Blood tests were ordered at the emergency department but the results were not available for him to review. Lab work performed (unknown which tests were done) was normal according to the patient''s mother. It was believed that no cerebrospinal fluid (CSF) analysis was performed. ON 31-MAR-2011 the patient was diagnosed with Guillain-Barre syndrome by the reporting physician. The physician referred the patient to a neurologist on 31-MAR-2011 who confirmed his diagnosis of Guillain-Barre syndrome. At the time of reporting, the patient had not recovered from Guillain-Barre syndrome. Follow up information has been received from the neurologist who reported that no vaccine was given to the student patient at his office. The patient was seen in office for neurological evaluation secondary to lower extremity weakness and was diagnosed with idiopathic cryptogenic neuromuscular disorder. There was no history of vaccine exposure given at that time related/unrelated. No evidence vaccine. Electromyography (EMG) and nerve conduction velocity (NCV) were performed and both were normal. On 13-APR-2011, the patient recovered from the adverse event. Guillain-Barre syndrome was not life threatening, but was disabling in the fact that the patient needed assistance with walking. Additional information has been requested.
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