Information has been received from a physician concerning a 12 month old male patient with no pertinent medical history and no drug reactions/allergies who on 03-OCT-2006 was vaccinated with a dose of PROQUAD (Merck upgrade process) (lot number, route and site not reported). There was no other vaccine concomitantly. It was reported that the patient had a febrile seizure on the day of vaccination with PROQUAD (Merck upgrade process). The patient was taken to the emergency room and given phenobarbital for several months. The patient had delayed speech patterns but no seizure that day. Upon internal review, febrile seizure was determined to be an other important medical event. Follow-up information has been received from the physician concerning a 12 month old male with hay fever and no known drug allergy who on 03-OCT-2006 was vaccinated with the first 0.5ml dose of PROQUAD (Merck upgrade process) (lot # 654471/0812F) via subcutaneous route (also reported as "IM"). There was no illness at the time of vaccination, and there was family history of seizure in an uncle. On 03-OCT-2006, about 9:35pm, the patient started seizure for approximately 5 minutes. He had fever with temperature of 101.0 F (38.6 degree C) rectally in the evening. The patient went to an outside hospital. CT of the head was negative. The lab tests showed that urinalysis AMORPH MATERIAL 1+ and hematology normal. The patient was sent home where he had another seizure (lasted 1-2 minutes). The parents brought him back to same facility where repeat RBC and he was found to have acute otitis media in the right ear. The patient was given ceftriaxone and transferred to a hospital. On 04-OCT-2006, the patient was admitted. During admission process, he had a third seizure with postictal sleepiness. His temperature was 38.0 degree C, pulse 174, BP 133/78. The patient was placed on seizure precautions. He was started on ceftriaxone for the otitis media and TYLENOL and MOTRIN as need for fever. Neurology evaluated and recommended DIASTAT with the first dose given in front of this parents. A sleep EEG on 05-OCT-2006 was normal and the patient was asymptomatic, tolerating PO and voiding/stooling. On 06-OCT-2006, the patient's temperature was 36.5 degree C, pulse 120, BP 110/54, and he was in good condition. On the same day, the patient was discharged with the discharge diagnoses of febrile seizures and right otitis media. The discharge instruction was as follows: took OMNICEF 4ml twice a day for 5 days for otitis media (ear infection), DIASTAT 5mg rectally if seizure lasted greater than 4 minutes. The patient was advised to have a follow-up appointment with his primary care physician on 09-OCT-2006 or 10-OCT-2006. In February 2007, the patient had 1 seizure when he had tonsillitis. On approximately 14-OCT-2007, the patient had right lower lobe pneumonia and 1 seizure. On 04-NOV-2007, the patient was admitted to the hospital again due to 3 febrile seizures in 9 hours starting night prior to admission. It was reported that most recently he had right acute otitis media, runny nose and a fever of 100.4 before these 3 seizures. During the seizures, the patient's whole body went stiff, jerks and shakes. His eyes rolled upward and he was unresponsive. Seizures were tonic clonic in nature, which normally lasted 3-5 minutes and he was tired for 30 minutes afterwards. The seizures were always associated with a febrile illness. The patient was given TYLENOL for fever, and he had seizures when TYLENOL was wearing off and fever returned. Upon admission, his temperature was 36.6 degree C, pulse 130, BP 69/35. The patient was treated with ZITHROMAX for right lower lobe pneumonia and acute otitis media. Neurology consulted for febrile seizures vs seizure disorder. 12 Lead EKG was performed to rule out long QT and respiratory virus isola was performed (results not provided). The patient had 1 seizure at the hospital that lasted 2 minutes. It was tonic clonic. He hit his head and had some blood in his mouth. His temperature was 39.2 shortly after the seizure. Neurologist wanted him to be placed on Phenobarbital 5m/kg at night but was reduced later to 75mg PO every night. The patient tolerated treatment well. No new issues. On 05-NOV-2007, the patient was in good condition and his temperature was 37.4 degree C, pulse 124, BP 92/57, and he was discharged with the discharge diagnoses of complex febrile seizures, right lower lobe pneumonia and right otitis media. The patient was advised to have a follow-up appointment with his primary care physician in 2 to 3 days and a follow-up appointment with another physician in 2 to 3 weeks. The discharge medications included azithromycin (100mg/5l) 5ml PO daily for 2 days, phenobarbital (30mg tablet) 2 1/2 tablets PO every night and DIASTAT accudial 5mg rectum once for seizure control if seizure persisted. The follow-up visit on 21-NOV-2007 indicated that the patient was on phenobarbital (30mg tablet) 2.5 tablets PO at night, and since then, he had no seizures. The follow-up visit on 22-JAN-2008 indicated that the patient had a recent seizure due to sinus infection and temperature of 102. He was on antibiotics and has had a little bit of diarrhea. The patient was still on phenobarbital 75mg PO at night. The follow-up visit on 27-MAY-2008 indicated that the patient had a slight fever. His last seizure was in January. He had mild developmental delay in regards to speech. Development was progressing and he was speaking normally and would start preschoool. The patient was on phenobarbital 32.4mg, 2.5 tablets PO at bedtime. The follow-up physician wanted to decrease phenobarbital and would see him back in several months time. At the time of the report, the patient's outcome for febrile seizures was unknown. The reporting physician considered that febrile seizure as be disabling due to develop mild development delay in speech. Additional information has been requested.