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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a consumer (patient''s mother) and the physician concerning a 15 year old female patient with allergy to BENADRYL, with heavy menses and no medical history who on 25-AUG-2011 (not 16 or 17 days prior to 28-SEP-2011 as reported by consumer), was vaccinated with the first dose of GARDASIL (lot number: 668262/0841AA, route not reported). There was no concomitant medication. Consumer reported that one week after her daughter was vaccinated, she experienced shortness of breath and 14 days after vaccination, she also started to experience "seizures" every 45 minutes. Consumer described the seizures as, "she jumps up and down and her chest hurts". Consumer reported that the seizures lasted for 30 seconds. Consumer also reported that while her daughter was sleeping, she experienced tremors in the legs, arms and head, and that in addition to the seizures, her daughter also felt weak, and she could "barely stand up or hold a pencil". Consumer and the physician reported that the patient went to two different emergency rooms before seeing the reporting physician, and, "the bloodwork is all normal". Physician reported that the patient did not receive any treatment for the adverse events. On 26-SEP-2011, the patient was seen by the reporting physician for the events and it was reported that the physician saw no seizure activity but could confirm tremors and weakness. A computed axial tomography (CT) and magnetic resonance imaging (MRI) were negative. The patient was referred to a pediatric neurologist. Consumer reported that her daughter had an appointment today to see a pediatric neurologist. The reporting physician could not address the life threatening criterion, but did not feel the events were disabling. No inpatient hospital confinement. The physician reported that, the patient had not recovered. Additional information has been requested.
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