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This is VAERS ID 517115

Case Details

VAERS ID: 517115 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:237
Submitted: 2013-12-18
   Days after onset:170
Entered: 2013-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Eye pain, Immunology test abnormal, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination abnormal, Optic neuritis, Optic neuropathy, Scotoma, Vision blurred, Visual acuity reduced, Visual evoked potentials abnormal
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular infections (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Migraine
Diagnostic Lab Data: Ophthamological examination: vision: 3/10 on right, central scomtoma.; Visual evoked potentials: consistent with optic neuropathy.; MRI: consistent with multiple sclerosis.; Neurological examination: right haze vision, no sensorimotor deficiency and no pyramidal nor cerebellar syndrome.
CDC Split Type: WAES1312FRA007615

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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