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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from the Health Authorities on 13-SEP-2011 under the reference number 2011-02931 via the local site Sanofi Pasteur MSD. A 15-year-old female patient, who had been taking CONCERTA for Attention Deficit Syndrome without any problems for a long time, had received the first dose of GARDASIL, (batch number NN52070) 0.5 ml. Secondary suspect therapy included the first dose of ENGERIX B, other manufacturer (batch number, AABVB963AA) 1 ml both via intramuscular route on 25-JUN-2011. On 29-JUL-2011 the patient developed sensory disturbances over the left side of her face that extended from the hairline to the middle of the cheek. An appointment was made with a neurologist to diagnose the symptoms, but there was no explanation for the patient''s symptoms. The patient was not given any specific treatment, and the symptoms have persisted until the present time. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as unlikely concerning GARDASIL and possible concerning ENGERIX B. Sensory disturbance was considered to be disabling by the reporter. Other business partner numbers included: E2011-05553. No further information available.
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