Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Brain oedema, Clonus, Convulsion, Drooling, Dysphonia
Clinical narrative: Initial report was received 20 May 2008 from a health care professional. Additional information was received 22 May 2008 from the same health care provider. A two-year-old male patient, who was an identical twin born at 32 weeks gestation, had received a third dose, left thigh intramuscular injection of FLUZONE 2007-2008, lot number UT2474CA, on 13 November 2007 and two days later, on 15 November 2007, he was admitted to the hospital with an admitting diagnosis of seizures. The patient had previously received a second dose intramuscular right thigh injection of FLUZONE, lot number U2504AA on 10 October 2007 with no reported adverse events. According to the reporter, patient had a past medical history which included chronic development delay NOS, blindness/low vision with CVI and extropia (the patient wears glasses), primary cardiomyopathy NEC and gastroesophageal reflux disease which required a "gastrotomy" tube placement on 18 May 2006. The patient was also noted to have been stable and no longer taking any cardiac medications (Captopril and Carvedilol); both of these medications had been discontinued prior to 12 September 2006. The patient had been receiving concomitant medications which included OCUFLOX 0.3% SOLN, TAMIFLU 12 mg/ml SUSR, PROTONIX 20 mg TBEC, and REGLAN 5mg/mL SOLN (start and stop dates not reported). According to a patient admission notification report, the patient was admitted to the hospital on 15 November 2007 with an admitting diagnosis of seizures. According to a VAERS report filled by the reporter on 19 November 2007, the patient was admitted on 17 November 2007 for acute loss of consciousness; however, the patient has a twin sibling (case 2008-01661) who had been hospitalized on 17 November 2007 with an admitting diagnosis of acute loss of consciousness. The following information will include information obtained from medical records received from the reporter. The patient had been seen by his neurologist for a follow-up evaluation on 22 April 2008 with a chief complaint of nonconvulsive epilepsy. According to the patient's history recorded in the neurologist's clinic notes, the patient experienced an episode of nonconvulsive status epilepticus in November 2007 which occurred one to three days following vaccination. Follow-up EEG showed no electrographic seizures and essentially normal background with some slowing in the left temporal and frontal central regions. MRI showed right temporal lobe atrophic changes. Focal edema was also seen in the left thalamus. A comparison MRI In May 2006 suggested atrophic changes in the right temporal lobe also existed at that time. The thalamus, however, was normal. The patient's family history noted the patient had a twin sibling with the same condition, although that twin required a heart transplant. Multiple testing had been performed when the diagnosis was made (diagnosis not specified). Metabolic and mitochondrial abnormalities were considered, however a definite diagnosis had not been made. Current prescribed treatments included valproic acid 150 mg t.i.d. and according to the patient's mother, the patient had not experienced any seizures and no evidence of trance like behaviors. The patient was described as doing well and progressing, but was significantly delayed and functioned at a level between 6 months and one year of age. He had a G-tube and was only able to take small feeds orally. Physical examination findings noted during the patient's follow-up neurological assessment on 22 April 2008 indicated the patient was hypotonic, nonverbal, but made expressive vocalizations with different sounds, but no distinct consonants. He had significant drooling, occasional ocular flutter and poor visual fixation with no following observed. His right eye was patched for strabismus. Facial movements were full and symmetric. He had very low tone in his axial and proximal musculature, brisk reflexes, particularly in the lower extremities where clonus was elicited. The patient could not strongly plantar flex his toes. He sat in a tripod position only briefly and his arms extended fully in a prone position. The neurologist impression was nonconvulsive status epilepticus, global developmental delay, hypotonia, and cardiomyopathy. The recovery status of the patient pertaining to the event of seizure and nonconvulsive status epilepticus was not reported. Documents held by sender: clinical records, neurology consult. The reporter for this case is the same as for case 2008-01661.