Age: 1.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Tonsillar disorder, Tonsillar hypertrophy, Tympanic membrane hyperaemia, Urine analysis normal, Viral infection
Clinical narrative: Information has been received from an investigator concerning a 1 year old female who entered a study. On 21-MAY-2007 the patient was vaccinated with a (5 ml dose ProQuad). It was unknown whether the patient received Prevnar or PedvaxHib. Concomitant medication included Zantac for reflux. On 29-MAY-2007 the patient experience a seizure. Medications used to treat the fever accompanying the seizure were Motrin (dose unknown) and Tylenol (dose unknown). The patient was hospitalized on an unknown date for the seizure. At the time of the report, the patient had not yet recovered from the seizure. The investigator considered the event to be related to study drug. Follow-up information was received on 04-JUN-2007. The patient also received Prevnar 0.5 ml on 21-MAY-2007. She did not receive PedvaxHib. The patient's history included acid reflux, apnea and mother was cocaine positive. Medications used to treat the fever were Motrin 100 mg and Tylenol prn (dose unknown). On 29-MAY-2007, the patient had a seizure at home lasting 4-5 minutes with altered mental status and prolonged "fixed stare." She had been  experiencing a fever for the last two days, with no vomiting, diarrhea or coughing. It was reported that she had been tugging on her left ear. On 29-MAY-2007, the patient arrived at  01.33 AM to the emergency department via ambulance. Admission physical examination showed appropriate breathing, circulation and mental status. The patient was not reported to be in pain. Temperature was 103.8 F, and oxygen saturation 100% room air. Her right tympanic membrane was erythematous with fluid and pus behind ear. She had no rhinorrhea, pharynx was without erythema or lesions and there was no tonsillar hypertrophy. On 29-MAY-2007, urinalysis was normal. Blood analysis revealed the following: glucose 106 mg/dL, blood urea nitrogen 11 mg/dL, creatinine 0.4 mg/dL, sodium 136 mmol, potassium 3.9 mmol, chloride 103 mmol, CO2 21 mmol, total  calcium 9.7 mg/dL, anion gap 11, osmolality calculation 272 MSMK, WBC count 13.5 K/uL, RBC count 4.45 M/uL, hemoglobin 13.2 g/dL, hematocrit 38.5, platelet count 347 K/uL, polynuclear neutrophils 67%, lymphocytes 25%, monocytes 7%, eosinophils 0% and basophils 1%, CRP 8.29 mg/dL, AST 46 IU/L, ALT 19 IU/L, total bilirubin 0.5 mg/dL, albumin 4.1 g/dL, total proteins 7.4 g/dL. The patient was discharged at 07:00 AM on 29-MAY-2007. The clinical impression was probable febrile seizure vs. syndrome; CNS process very unlikely. Discharge care instructions included Tylenol and Motrin PRN for fever and instruction to follow-up with primary care physician (PCP) immediately. On 29-MAY-2007 the patient followed up with her PCP where her temperature was 100.8. She had another witnessed seizure and again presented to the emergency department at 11:35 AM. Temperature on arrival was 105.2. Oxygen saturation was 100% room air. Tympanic membranes were without erythema, no rhinorrhea, pharynx had bilateral tonsillar erythema, lesions were noted on both tonsils and tonsillar hypertrophy was noted. She was given Tylenol, Motrin and ceftriaxone, and placed on a cardiac monitor and oxygen saturation monitor. A lumbar puncture was performed to rule out meningitis. Cerebrospinal fluid was drawn, no organisms were seen. The CSF protein was 11; results were otherwise unremarkable. Other lab results were normal. On 29-MAY-2007, EEG was performed and during the EEG the patient had a generalized tonic-clonic seizure lasting approximately 1 minute. She was treated with Cerebyx 200 mg. An EEG was performed the following day with unremarkable results. On 30-MAY-2007, a CT of head without contrast was normal. The patient was discharged from the hospital on 31-MAY-2007. She was alert, afebrile and ambulating well. Discharge diagnosis was febrile seizures secondary to viral illness. On 04-JUN-2007, the patient was seen in the clinic. She appeared alert, afebrile and ambulated well. EEG X 2 was unremarkable and MRI was negative. The patient has not yet recovered from the febrile seizure. The investigator feels that the febrile seizure is possibly related to study medication. The patient's febrile seizure was considered disabling and serious for hospitalization. Additional information has been requested.