Information has been received from an investigator concerning a 3 month old infant who received the 1st dose of Prevnar as part of a trial. On 07/28/00, the infant developed increasing episodes of "on and off" muscle spasms. On 07/29/00, the infant developed a single episode of muscle spasm with "one cry", and was seen in a clinic for evaluation. A diagnosis of benign infantile myoclonus was made. An EEG was performed, and the results were found to be normal. Myoclonic jerks is considered medically important. As of the date of this report, both the investigator's and the medical monitor's assessments are unknown. Follow up information on 04/19/2001 indicated that both the investigator and the medical monitor agreed that this event was not related to study vaccine administration.  A follow up report received 12/03/2001 adds: No complications at birth. Gest age-40 weeks normal heart rate, resp rate, voiding, sucking, etc., breastfeeding well. Baby did well in course at home. On 4/11/00, at 12 days of age parents bring child in for concern re congestion, concerns re strained breathing. Good general exam with dx URI, healthy newborn. 04/17/00 normal exam, mild nasal congestion. 4/28/00 seen for nasal congestion, mostly at night. 4/29/00 diaper rash. 5/17/00 congestion, well (vaccinated). 5/22/00 seen for 1. diaper rash, dx'd candida 2. concern re "jerking" movements of neck and extremities, no cries or change in behavior. Development appropriate, no neonatal hx of significance. Description consistent with benign myoclonic seizures. Mother to videotape. Consider neuro referral. 5/15/00 concern re arm/leg movements. Mother brought in video: observed-normal flexion-extension movements, unlikely to be myoclonic spasms. Neuro exam normal. 5/31/00 Neuro referral made. States: 2 mo old male, unremarkable preg, labor and delivery. Normal neonats. Parents have noticed intermittent jerking of arms, legs, head. (Parent) brought a video but (provider) could appreciate spasms. Parents now concerned re increase in spasmatic jerks. She will re-video. Could this be benign myoclonus infantile? Please eval. 6/8/00 Seen for f/u. States: Prior concerns re "jerking" movements. Mom states now decreased. Developmentally: smiling, active. Assessed probable benign movements. 6/22/00: Parent concerned re muscle spasms. Presumed benign myoclonus. Occurring on and off with increase of episodes last night then 1 cry while occurring. Was able to feed. Occurred again this AM with ability to feed. Positive tears. Myoclonus occurs while sleepy. Assessed benign infantile myoclonus. Plan: "Reassured infant +dehydrte +normal causes of d/o to f/u ..call if activity significantly increases." 6/29/00 Neuro clinic: "This is a beautiful almost 3 month old baby who presented with 2 1/2 month history of recurrent episodes of abrupt jerky movements. According to the parents, both of whom were present today, the baby has been having this activity primarily when he is falling asleep or through the night. Sometimes it is so severe that it wakes him up. The parents had to hold the arms. There has not been sustained tonic clonic activity. The baby otherwise has been developing quite well, thriving and feding without difficulties. There has not been any episode of arching. No episodes of nausea, vomiting. "History: Pt was the 6lb 13oz product of a full term pregnancy. At 32 weeks of gestation the mother had some per-term labor that was controlled with Nifepdipine. The mother took prenatal vitamins. Significant history has been negative other than the above. Circumcision was uneventful. The father is 36, the mother is 31. The father is caucasian. The mother is african american. The mother has a maternal cousin with a history of "muscular dystrophy". He is 33 years of age. He ambulates "with braces." Reportedly he also has seizures. The exact type of muscle disorder is not known by pt's mother.  "Physical exam: normal. "Neuro exam: the baby was quite awake and alert, smiling, nicely fixating. Some simple cooing was noted. The cranial nerves appear equal and reactive. There was ophthalmoparesis. No nystagmus. The face was symmetric. Lower cranial nerves were normal. "Motor exam: The axial and perpendicular tone were normal. There was no evidence of tremors. No evidence of polyminiclonus. "Sensory exam: There was sensory recognition to pain. Deep tendon reflexes were 2+ in both arms and both legs. Plantar responses were down going. "Impression: Recurrent marked clonic activity during sleep. This clinical pattern is consistent with benign asleep myoclonus of early infancy. The examination today did not reveal the presence of any findings that suggest motor sensory deficits. The later on probability of that needs to be considered and followed, although not likely." "Recommendations: Obtain EEG. No medication indicated. If the EEG is normal certainly the symptom is consistent with benign asleep myoclonus. Unless he becomes more symptomatic or there is evidence of potential seizures or any significant abnormalities in the EEG, I do not think that neuroimaging is indicated at the present time. 7/23/00 exam for ear problem, no mention of jerking. 7/28/00: well care, states "recent appt with neurology-concerns that movements are benign myoclonus". Neuro exam at this visit states strong, reflexes normal, attempting to roll over, smiling. 8/2/00 EEG normal EEG recording in wakefulness for age. 9/13/00 well care visit w/o mention of concern other than statement of hx of benign infantile myoclonus. Imms delayed to URI symptoms. 9/29/00 OK for shots, immunized. Dx'd possible murmur, innocent vs. VSD. 10/04/00 ER for vomiting "likely reflux vs early gastro". 10/11/00 urgent care for rash on hand and face, vomiting, thrush. 10/27/00 f/u for murmur. Dx innocent murmur. 11/10/00 facial rash dx mild trauma vs bite. 11/22/00 URI. 12/04/00 URI. 12/20/00 well care mentions prior hx benign myoclonic movements and innocent murmur, normal child.