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Life Threatening? No
Write-up: Information has been received from a physician, concerning a 14 year old female patient, with anxiety and depression and no known drug allergies, who was vaccinated IM with the first, second and third doses of Gardasil, 0.5 ml, as follows: dose one on 29-MAR-2007, (lot #653736/0014U), dose 2 on 04-JUN-2007 (lot #656371/0181U), and dose 3 on 05-OCT-2007 (lot #659435/1265U). Concomitant therapy included sertraline HCl (ZOLOFT), mirtazapine (REMERON) and topiramate (TOPAMAX). In mid-April, following the first dose, the patient experienced a seizure. The seizures have occurred weekly. The patient was seen in the emergency room 4 or 5 times, and was examined by a neurologist (details not provided). A 24 hour electroencephalogram showed no epileptic activity, and imaging of the head showed no mass or tumors. The seizures were further described as tonic clonic, with aura. It was not known if the patient was actually hospitalized. At the present time, the patient was not being treated with anti-seizure medications, and the source of the seizures had not been identified. At the time of this report, the seizures were ongoing. The physician considered the events to be serious, as an other important medical event, and as disabling/incapacitating. Additional information has been requested. 3/23/09 Received hospital medical records of 3/29/07-12/11/2007. FINAL DX: no d/c summary dictated & neuro consult dx non-epileptic events, possible panic attacks. Records reveal patient experienced possible seizures since 4/2007. Right anterior ilias spne tenderness & difficulty walking 8/3/07, hip x-rays neg. Admitted on 11/14-15/07 for video EEG. Symptoms included falls, shaking lasting 1-10 min, fatigue, dizziness, metal tast, unable to speak, heart fluttering, nausea/vomiting, anorexia. Neuro examination WNL. Returned to hospital 12/11-12/12/2007 for continued possible partial seizure/syncope episodes. Neuro examination WNL. When 48hr video EEG neg, referred to psych. 4/29/08 Received Neuro consult of 11/8/2007. FINAL DX: Seizure, possible complex partial seizure. Psychogenic nonepileptic events cannot be entirely ruled out. Syncope. Records reveal patient experienced increasingly frequent episodes of fatigue, dizziness, metallic taste & disorientation. Was currently on antiseizure meds & had normal EEGs & CT scan. Antiseizure meds were d/c & pt scheduled for video EEG.
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