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Life Threatening? No
Write-up: This case was reported by a physician and consumer (subject''s father) via a regulatory authority (# ES-AGEMED-539945340) and described the occurrence of gait disturbance in a 11-year-old female subject who was vaccinated with TWINRIX pediatric, (GlaxoSmithKline) and GARDASIL, (non-GSK). On 23 January 2014, the subject received unspecified dose of TWINRIX pediatric (.5 ml, intramuscular, unknown injection site and batch number) and unspecified dose of GARDASIL (.5 ml, intramuscular, unknown injection site). On 23 January 2014, less than 1 day after vaccination with TWINRIX pediatric, the subject experienced dizziness. At about 30 minutes later, she was improved and was administered GARDASIL. The dizziness occurred again and resolved the same day. the subject was also suspected to have neurological infection. On 24 February 2014, the subject''s parents informed that she was on a wheel chair. On 25 January 2014, the electromyogram was performed and the results were normal, ruling out any form of neuromuscular pathology. On 27 January 2014, the subject was hospitalised for the study of the walking alteration and loss of force in the lower limbs was observed. The subject''s father reported that the events were disabling. On 29 January 2014, the motor nerve conduction test was conducted without any alterations in speed. On 6 March 2014, the subject was discharged and as per the discharge report, the neurological infection was changed to gait disturbance. At the time of reporting the gait disturbance was improved. No further information was expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK. Therefore the case has been closed.
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