Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Electroencephalogram abnormal, Lumbar puncture normal, Myoclonic epilepsy, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination normal
Clinical narrative: Initial report received on 13 May 2009 from a physician. Subject identification number: 1-08-06459. This subject is participating in a study. A 14-year-old previously healthy male subject, who has concurrent medical condition of mild asthma, for which he uses XOPENEX on an as needed basis, had received on 30 November 2008 a dose of FLUZONE, lot number U2803AA. The route and site of administration was not reported. The subject presented with prolonged, generalized new onset of seizure and status epilepticus (onset date not reported) and was hospitalized from 30 November 2008 to 02 December 2008. There was no history of trauma, or substance abuse. Urine drug screen was negative. An MRI with/without contrast on 01 December 2008 revealed no intracranial abnormalities and with abnormal signal in the left middle ear cavity and mastoid region. An EEG was normal without epileptiform discharges. Cerebral spinal fluid Polymerase Chain Reaction was negative for enterovirus and herpes simplex virus. Blood culture was sterile. It was elected to observe the subject without anti-epileptic medication. The subject was discharged on hospital day three. The subject was re-admitted two days later from 04 December 2008 to 06 December 2008 for seizures (onset date not reported). The subject was loaded with fosphenytoin and ATIVAN. Urine drug screen was negative. Head CAT scan did not reveal hemorrhage or other intracranial pathology. A soft tissue density in the left mastoid was observed consistent with cholesteatoma. The subject was discharged home on hospital day three with KEPPRA 300 mg twice a day for prevention of seizures. The subject was re-admitted three days later from 09 December 2008 to 24 December 2008 for seizures (onset not reported). A lumbar puncture test was performed that revealing CSF protein of 50.9 mg/dL and glucose of 71mg/dL, both are within normal values. Urine drug screen was negative, repeat CAT scan of the head did not reveal any new findings, respiratory virus panel was negative and an EEG revealed marked slowing of the background consistent with persistent encephalopathy without accompanying seizure activity. A repeat EEG on 15 December 2008 revealed discharge events indicative of myoclonic seizures. The subject had an EKG that had ventricular tachycardia; however an echocardiogram of the heart was normal. Muscle and skin biopsy of the left thigh was performed to evaluate for progressive myoclonic epilepsy of the Lafora type; however, results of pathology test demonstrated no globules consistent with Lafora. Ophthalmologic examination was unremarkable. The subject was sent home on hospital day 16 on DEPAKOTE 1500 mg twice a day and rectal DIASTAT 17.5 mg for seizures lasting greater than five minutes. The subject's final diagnosis was new onset seizure, status epilepticus, myoclonic epilepsy. Recovery dates were not reported. Per the reporter, "none of the three serious adverse events were related to the he FLUZONE, and the SAEs not going to be reported to the IRB, or to VAERS." Documents held by sender: None.