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Life Threatening? No
Write-up: Case received from the Health Authorities in a foreign country on 12-Dec-2013 under the reference number TO20132233. Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # FR-1577272925-E2013-10696) on 17-DEC-2013. A 15-year-old female patient with a medical history of migraines had received the three doses of GARDASIL (batch number not reported) via intramuscular route on 10-Jul-2012, 24-Sep-2012 and 06-NOv-2012. In the middle of Jul-2013, the patient presented with visual disorders associated with retro orbital pain in the right eye. Retrobulbar optic neuritis was diagnosed. Indeed, right vision had decreased to 3/10 P4, which confirmed the presence of central scotoma and visual evoked potentials were consistent with optic neuropathy. SOLUMEDROL 1g led to a regression of the retrobulbar optic neuritis. MRI and autoimmune work-up were consistent with multiple sclerosis. Non drug-induced etiologies ruled out: Neurological examination was unremarkable except for right haze vision. There was no sensorimotor deficiency, no pyramidal nor cerebellar syndrome. Treatment with BETAFERON was initiated, and repeat encephalic and medullar MRI was recommended at 3 months. At the time of reporting, the patient had not recovered from multiple sclerosis, and had recovered with sequelae from retrobullar optic neuritis. To be noted that the patient''s father had a medical history diabetes. The patient was not taking any disease-modifying treatment. Upon medical review the company judged relevant to code the adverse event retrobulbar optic neuritis which was mentioned by the Health Authorities in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C2 S1 I1) according to the Foreign method of assessment.
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