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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This spontaneous report as received from a pharmacist (patient''s father) via company field representative refers to a 12 years old female patient. The patient''s medical history and concurrent conditions were none. On an unspecified date in July-2015 the patient had received her second dose of GARDASIL, lot # and expiry date was not reported. The patient had received unspecified concomitant medications. On an unspecified date in July-2015, the patient experienced visual disturbances (disability) and optic neuritis (disability). Therapy with GARDASIL was discontinued on an unspecified date in July-2015. Later in December-2015, she had chronic seizures (disability). Recently, on an unspecified date, she was diagnosed with inflammation of the left hemisphere of her brain (disability) and she could not speak (disability). The GARDASIL was not reintroduced. The outcome of the events were reported as not recovered. Upon internal review the events cannot speak, chronic seizures and inflammation of the left hemisphere of her brain were considered to be medically significant. Additional information has been requested.
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