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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a physician via a regulatory authority (# 2011-02931) and described the occurrence of sensory disturbances in a 15-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), GARDASIL (non-gsk). Concurrent medical conditions included attention deficit hyperactivity disorder. Concurrent medications included CONCERTA since a long time, due to attention deficit hyperactivity disorder. On 25 June 2011, the subject received 1st dose of ENGERIX B (1 ml, intramuscular, unknown site of injection) and 1st dose of GARDASIL (.5 ml, intramuscular, unknown site of injection). On 29 July 2011, 34 days after vaccination with ENGERIX B and GARDASIL, the subject experienced sensory disturbances at the left side of the face, which ranged from the hair line to the middle of the cheek. For clarification of the complaints, a consultation of a neurologist was arranged; however no explanation for the complaints of the subject was found. The patient did not received specific therapy. The regulatory authority reported that the event was disabling. At the time of reporting, the event was unresolved. The regulatory authority reported that the event was possibly related to vaccination with ENGERIX B and was unlikely related to vaccination with GARDASIL. Further details will be provided by the Regulatory Authority whenever available.
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