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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from a consumer on 18-APR-2011. Case not medically confirmed. A 15 year old female patient had received a first dose of GARDASIL (batch number not reported) on an unspecified date and following vaccination the patient developed multiple sclerosis experiencing 3 relapses in 2 months. According to the reporter, the patient''s father, the patient had serious sequelae. Additional information received from the Health Authorities on 22-APR-2011 under the reference number BX20110458. Case medically confirmed. The patient had received a first dose of GARDASIL (batch number not reported) intramuscularly on 11-OCT-2010 and experienced the first symptoms 2 to 3 weeks after vaccination. The patient had experienced 4 acute demyelinating attacks since that time. An MRI was performed resulting in suspect acute demyelinating encephalopathy with lesions, a lumbar puncture revealed oligoclonal bands and a neurological examination showed abnormal results. Visual evoked potentials were altered. The patient was diagnosed with multiple sclerosis. The patient would had been hospitalized twice (to be confirmed) and she received twice 3 days of corticosteroid bolus IV injection. The patient received a second dose of GARDASIL (batch number not reported) on 13-DEC-2010. Patient''s family medical history included her brother, father and grand father with insulin dependent diabetes mellitus and cousins with immune dysfunction disease. At then time of the reporting, the patient had not recovered and the outcome was reduced visual acuity and walking disability: wheelchair user. The Health Authorities assessed the causal relationship between the reported reaction and vaccination as doubtful (C1 S1 11) according to the method of assessment. Multiple sclerosis was considered by agency to be disabling. Other business partner numbers included: E2011-2535. No further information is available.
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