Age: 0.83
Sex: U
Vaccine: PNC
Symptoms: Infantile spasms
Clinical narrative: Information has been received from an investigator concerning a child who received a first dose of Prevnar as part of a trial. On an unspecified date, the child experienced infantile spasms. The event was managed with clonazepam. As of a follow up clinic visit on 07/11/00, the event had resolved. This event was considered medically important. Both the investigator's and the medical monitor's assessments were unknown. The child received a second dose of Prevnar on 08/07/00. No adverse event stemming from the subsequent vaccination has been reported. Follow up information receieved 04/19/2001 from the study investigator revealed the patient received Prevnar 06/01/2000. The investigator considered the event "outside the reportable window" and therefore, not related.   A follow up report received 12/3/2001 adds: 11/16/1999 Well care states birth weight 8lb 4oz normal exam. 01/19/2000 normal exam. 01/26/00 2d hx of SOM, 1d cough, 2d runny nose assessed UI. 01/30/00 asthma, recurring OM. 01/31/00 asthma, doing better, tolerating meds well. 2/09/00 Seizure? seen in urgent care clinic for hx of 3 possible seizures with light fever, cough congestion. 1" 14 weeks ago when using albuterol. Eyes rolling back, "crunched body". Poss seizure disorder? scheduled EEG. 02/10/00 another episode today where crunched body and eyes rolled back lasting -30 seconds. Assessed infantile spasms, admit for Rx Klonopin. 02/10/00 neuro eval. States: Infantile spasms. Previously healthy infant described as starting new activity of arm/leg flexion, coincidental with starting nebulizer medication was discontinued and he continued to have this activity.. Discussin with pediatrician this AM, I recommended an EEG to evaluate for infantile spasms. Result indicate hypearrythmia. Fam hx sister with febrile seizures. Nondysmorphic. Exam: Well appearing male, no abnormality detected. Impression: infantile spasms by hx. Recommendations: 1. MRI to r/o structural lesion (e.g. TS). 2. Start Klonopin 0.01 mg/kg 012. 3. Order ACTH 20 in/day for 2 wks when gradual taper by 5 units over every 5 days, followed by Prednisone 2mg/kg with taper over 2 wks. 4. Woods lamp evaluation. 02/10/00 Markedly abnormal EEG because of frequent, multifocal and generalized epileptiform activity and high amplitude slowing of the background. Consistent with hypsarrhythmia. Discharged 02/15/00 with dx infantile spasms. 2/21/00 urgent care appt for 2 episodes that day, also URI, w/o fever. 02/28/00 seen for an rx but continues to have seizures assessment. 02/29/00 EEG abnormal again consistent with infantile spasms. 03/20/00 well child visit states: 1. well child. 2. infantile spasm with box checked indicating normal neuro exam as part of physical. To continue Klonopin, prednisone taper. 03/28/00 neuro exam. Impression: Hx of infantile spasms, now improved, mild dev delay. Plan 1.continue Klonopin, prednisone as scheduled 2. return to clinic 2 wks. 04/07/00 second opinion neuro re infantile spasms. Impression infantile spasms, dev delay global, mild hearing deficit. 04/11/00 f/u of infantile spasms. No seizures since restarting Klonopin. Now off prednisone. Questions re hearing and left sided stiffness, mother reports poor vocalization. Exam: awake with eyes half lidded. EOM full and conjugte. Positive smile. Intermittent reactivity to sound, muscle tone good, normal/symmetric. Moving all four extremities, 0 hand preference, 0 parachute reflex. Sitting independently. Impression s/p infantile spasms, 7 hearing deficit, mild developmental delay plan continue Klonopin, referral to ophthalmology re eyes, EEG, audiology, return to clinic 1 month. 04/26/00 EEG wnl. Normal EEG for a child of this age, awake, drowsy and asleep. 05/04/00 cough. 05/09/00 f/u for inf spasms/dev delay. Repeat EEG normal. Development advances but no language. Exam: alert, playful, reacts to sound startle with good localization. 0 parachute reflex, 0 hand pref. positive taking grasp. Plan 1 decrease Klonopin to 1/2 tab in AM, 1 tab in PM. 2. RTC two months. F/U by phone. 5/17/00 Ophth exam states hx infantile spasms, pt seems to have problems focusing, slightly squinting, assessed: Pt was previously looking through eyes half-lidded but currently is not doing this-visually occurs with ptosis-had mult infantile seizures-it may be that the ptosis has improved with the seizure control plus stropine retraction. Normal ophthalmic exam. Probably pseudostrabismus return 1 year. 06/01/00 well child visit well 10 month old with h/o infantile spasms, speech delay. 06/23/00 urgent care appt for diarrhea. 07/10/00 EEG normal. 07/11/00 neuro exam: f/u for inf spasms, on Klonopin 0.1mg QD, no problems/seizures. Development continues, now cruising, moreo babbling. Exam alert playful male, squeling, muscle tone normal, no hand preference, pulling to stand with ease and stopping-pupils equal, round, reactive to light and accomodation, normal EOM. Impression resolved infantile spasms. Plan decrease Klonopin to 1/2 tab daily (0.05mg) return in 2 months. 7/17/00 cough. 08/07/00 well child, well 12 month old w/hx inf spasms, nl development (followed by regional center). 10/03/00 neuro f/u. No reports of seizures, more babbling. He has been walking for the past 6 weeks, no new issues, recurring OT, scheduled to meet with speech therapist. Exam: awake, playful male, babbling focussing on toys/faces. PERRL, ECMI, muscle tone/bulk normal. Walking well with wide based waddle, plan decrease Klonopin to 0.05 mg QD, return 7 months. 10/18/00 difficulty breathing, woke up from nap with difficult breathing, now with croupy cough. States "Dx asthma January, given med that gave him seizure. Now on Clonazapam". Dx mild tachypnea, febrile illness. 11/09/00 well child visit 15 month old w/hx of infantile spasms followed by neurologist, hitting developmental milestones. 11/10/00 eyebrow laceration. 12/05/00 neurologist: no reports of recurrent seizures, language has advanced-now babbling and having repetitive play, speech therapist is pleased with progress. Exam well appearing, no active disease. Decrease Klonopin to 0.05 mg QM, Th through 12/25/00 then 0.05 mg QM through 1/15/01, then stop. 01/04/01 tugging at ear 5-6 days. 01/23/01 neuro f/u for infantile spasms and speech delay. Off Klonopin as of 01/15/01 without recurrence in seizures. Still receives speech therapy through regional center. No new issues, family about to change insurance, f/u as needed. 01/28/01 ear pain, URI few days. 06/22/01 ophthalmology appt failed to keep/cancel.