Information has been received from an investigator concerning a child who received a 1st dose of Prevnar as part of a study. The child had a history of cerebral palsy, developmental delay, and epilepsy managed with phenobarbital. The child's mother discontinued phenobarbital in 9/00, and the child began to experience startling episodes with sudden, rapid, bilateral arm abduction and extension with arching of his upper body and throat noises. The episodes last a few seconds and occur several times daily without any precipitating event. Upon clinic follow-up on 11/14/00, a dx of "most likely seizures" was made and Tegretol therapy was initiated. This event was considered "Medically Important". As of the date of this report, the investigator and the medical monitor assessments were unknown. Follow-up information received on 14 NOV 2001 revealed the child was born prematurely at 29 weeks gestation and had a history of "probably" pediatric respiratory distress syndrome which required ventilator suppor and apnea monitoring at home. The child also had a history of gastro-esophageal reflux. The child was administered prevnar on 26 MAY 200, at the age of 12 months. Concomitant medications included phenobarbital. Within two months of the discontinuation of phenobarbital therapy, the child experienced the epileptic episode described above. The exact onset of the episode was unknown, but it was reported at a neurology clinic visit on 14 NOV 2000. Tegretol (carbamazepine) therapy was initiated and a follow up appointment was scheduled at 2 months. On 28 DEC 2000 however, the child was hospitalized for acute gastroenteritis and gastro-esophageal reflux, nine days after being diagnosed with pneumonia. See case ID# HQ7672126FEB2001 for the report on that hospitalization. In MAR 2001, the child's mother reported that she noticed an increase in the child's muscle tone with facial muscle asymmetry and increased extremity spasticity/rigidity. The mother also reported that the child cries alot during the daytime and that his "trunchal muscle tone is not good and he has difficulty supporting himself in a chair." A Tegretol level was obtained and was reported as "ok". In JUN 2001, the child's mother reported that he has been seizure free since MAY 2001. The child's mother discontinued Tegretol therapy after the family went on a trip without the child's medication and he reportedly did "fine". A follow up report received 12/03/2001 adds: Past medical history: Subject born at 29 weeks gestational age by cesarean section. Had what was probably pediatric respiratory distress syndrome and was on ventilator for approximately 2 weeks. Weaned off briefly before he had the need for further ventilation before he went home. Sent home on apnea monitor. A visit not at 7 weeks indicates that pt had approx 2-3 apnea spells per day. Also seen at 7 weeks in ER for GE reflux. Diagnosed with cerebral palsy spastic quadriparetic pattern with general tightness. Seen regularly in orthopedics and physical therapy since 10/99. Child receiving physical therapy from "spontaneous motions, activities of his hands, and what sounds like increased spine tone and neck movements." Starting in early 1/00 mother begins to describe a change in his movements and he is evalated for seizures. MD described "tonic flexion of his arms, followed by extension, followed by a cry". Episodes last about 16 seconds and happened 3-4 times per week. In mid April mother describes increased episodes of asymmetric facial grimacing (pulls to left), with the arm movements and increased frequency to maximum of 4x in 24 hours. MD suggests starting phenobarb at this time 5 mg/kg/d (starting at 30 mg/tab, crushed and fed with food once daily). Received Prevnar on 5/26/00 and 12/08/00. On 11/14/00 pt seen by neurologist for follow-up for seizure condition. At this tmie history of cerebral palsy and generalized seizures is cited. Taking phenobarbital until 2 months prior to this visit but mother discontinued it. Behind in developmental milestones. Mother describes episodes when he seems to startle without any stimulus or aggravating factor. These episodes consist of a sudden rapid bilateral arm abduction and extension with arching of his upper body and is sometimes associated with a throat noise. It lasts a few seconds, and gradually he relaxes. He has a scared look in his eyes when this happens. This happens every day, several times a day unrelated to outside factors. Assessment: History of epilepsy, new episodes of sudden arching and extension of arms are most likely seizures. He also has CP, start on Tegretol, recheck in 2 mos. Hospitalized 12/28/00 for chief complaint vomiting. Hx of present illness states: "The pt is a 19-month-old male with CP who used to vomit approx once every other day but for the last 3 weeks has been vomiting 4-5 times a day. Since 12/24 he has been "constantly vomiting." Seen on 12/19 for cough and vomiting and dx'd with pneumonia, started on oral amoxicillin. At this visit, note states the following 5 problems: 1. Noisy breathing: they state that he has been evaluated in pediatric pulmonology who told parent that he was at risk for recurrent pneumonia. Scheduled for airway endoscopy. 2. Seizures: "He first had a seizure at 6 months of life. He was initially treated with phenobarbitol, however, for the last 4 weeks he has been on Tegretol and takes 40 mg 3 times a day. Recently, he hs been having 2-4 seizures per day; the mother attributes this to the fact that he is not retaining his anticonvulsant medications. 3. Developmental delay: He is unable to sit by himself. He does not crawl or stand. Additionally, the mother states that he has had a problem with tongue thrust and hyperactive gag reflex. 4. Cerebral palsy: He is followed by physical therapy, speech therapy and occupational therapy. 5. Wheezing. He has been treated in the past with albuterol. Initial impression indictes: 1. Hx of prematurity and CP with dev delay. 2. Hx of seizures. 3. Hx of noisy breathing and report that the pt is at increased risk for aspiration. 4. Hx of bronchospasm. 5. Hx of recurrent vomiting. Must consider acute gastroenteritis with acute versus chronic gastroesophageal reflux. No discharge summary dictated for this hospitalization but online record states diagnoses of: Nonin gastroenterit nec, oth convulsions, congenital quadriplegia, esophageal reflux, development delays nec. In March 01 note in chart stating that mother called re Tegretol level: "Mother has noticed recently and in the past that his muscle tone increases and he develops facial muscle asymmetry when he gets below a therapeutic level". Note states that his Tegretol level is to be adjusted to a 3.5 cc TID. Another in 3/01 indicates "Mother reports a lot of crying during the daytime. He seems to need to entertained most of the day. Gradual increase in extremity spasticity/rigidity. Trunchal motor tone is not good and he has difficulty supporting himself in a chair. PT is working with mother. Last year was seen by MD and the issue of using Baclofen was discussed. Mother decided not to use it because of condern about decreasing trunchal tone but she would like to reconsider this now. Tegretol level was OK. Assessment: CP with severe spastic quadriplegia." Note in June 2001 indicates: (Pt) is a child with quadriparesis secondary to CP, which is secondary to prematurity. He has history of epilepsy in the past but has been seizure free recently and is off antiseizure medications at present (earlier in note states Mom discontinued Tegretol in May after she left it at home while on a trip and child did fine without).