Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Autoimmune disorder, Biopsy brain normal, Borrelia test negative, CSF oligoclonal band present
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient Information Act. This spontaneous report as received from a regulatory authority refers to a 21 years old female patient with condyloma. The patient was vaccinated with dose 1 GARDASIL on 16-JUL-2009. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2009 the patient experienced dysarthria (hospitalization, disability and life threatening), 18 days after onset of therapy, visual impairment (hospitalization, disability and life threatening), vasculitis cerebral (hospitalization, disability and life threatening), vaccination complication (hospitalization, disability and life threatening), tremor (hospitalization, disability and life threatening), thinking abnormal (hospitalization, disability and life threatening), substance induced psychotic disorder (hospitalization, disability and life threatening), speech disorder (hospitalization, disability and life threatening), screaming (hospitalization, disability and life threatening), plasmapheresis (hospitalization, disability and life threatening), peroneal nerve palsy (hospitalization, medically significant, disability and life threatening), pain (hospitalization, disability and life threatening), orthosis user (hospitalization, disability and life threatening), muscle spasms (hospitalization, disability and life threatening), monoplegia (hospitalization, medically significant, disability and life threatening), memory impairment (hospitalization, disability and life threatening), leukoencephalopathy (hospitalization, medically significant, disability and life threatening), intensive care (hospitalization, disability and life threatening), hypoaesthesia (hospitalization, disability and life threatening), hemiplegia (hospitalization, medically significant, disability and life threatening), hemiparesis (hospitalization, medically significant, disability and life threatening), headache (hospitalization, disability and life threatening), gait disturbance (hospitalization, disability and life threatening), emotional distress (hospitalization, disability and life threatening), dystonia (hospitalization, disability and life threatening), depression (hospitalization, disability and life threatening), confusional state (hospitalization, disability and life threatening), central nervous system lesion (hospitalization, disability and life threatening), cardiorespiratory arrest (hospitalization, medically significant, disability and life threatening), autoimmune disorder (hospitalization, disability and life threatening) and activities if daily living impaired (hospitalization, disability, and life threatening). No treatment information was reported. The outcome of dysarthria, visual impairment, vaccination complication, tremor, thinking abnormal, substance induced psychotic disorder, speech disorder, screaming, plasmapheresis, peroneal nerve palsy, pain, orthosis user, muscle spasms, monoplegia, memory impairment, leukoencephalopathy, intensive care, hypoaesthesia, hemiplegia, hemiparesis, headache, gait disturbance, emotional distress, dystonia, depression, confusional state, central nervous system lesion, cardiorespiratory arrest, autoimmune disorder and activities if daily living impaired is unknown. The relatedness of dysarthria, visual impairment, vasculitis cerebral, vaccination complication, tremor, thinking abnormal, substance induced psychotic disorder, speech disorder, screaming, plasmapheresis, peroneal nerve palsy, pain, orthosis user, muscle spasms, monoplegia, memory impairment, leukoencephalopathy, intensive care, hypoaesthesia, hemiplegia, hemiparesis, headache, gait disturbance, emotional distress, dystonia, depression, confusional state, central nervous system lesion, cardiorespiratory arrest, autoimmune disorder and activities if daily living impaired is unknown fro GARDASIL. Additional information is not expected.