Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPIPVHIB, HEP, PNC
Symptoms: Electroencephalogram abnormal, Encephalopathy, Full blood count normal, Gaze palsy, Hyperreflexia
Clinical narrative: Initial report received on 02 June 2010 from an investigator participating in the above-mentioned epidemiological study under the reference number M5A11. A 6-month-old male subject experienced a seizure 5 days after receiving the following vaccines on 07 December 2009; a third injection of PENTACEL (lot number C3481AA); a third injection of RECOMBIVAX HB (Merck, lot number 1251Y); and a third dose of PREVNAR (Wyeth, lot number D92436). The subject had a history of static encephalopathy following hypoxic ischemic injury in the perinatal period. He had previously suffered from neonatal seizures, and had been weaned off of KEPPRA in July 2009. Since that time, the subject had continued to have daily episodes of shaking, although this was thought to be "normal jitteriness of an infant". Musculoskeletal hypertonia was noted on 19 November 2009. A physical exam conducted on 03 December 2009, 4 days prior to vaccination, noted reasonable tone during sleep. However upon awakening, he was hypertonic in all extremities with bilateral lower hyperreflexia and some tremoring noted in his face and arms with a right-sided gaze preference. Five days post-vaccination on 12 December 2009, the subject's parents reported seeing episodes of shaking or jerking movements of either the upper or lower extremities in conjunction with lip smacking or eyelid fluttering; these episodes occurred every hour and lasted for a few seconds each. The infant was brought to the emergency department, where a similar episode was witnessed. In consultation with pediatric neurology, the subject was started on a 20 mg/kg load of levetiracetam and admitted for overnight observation. Electrolytes and CBC were within normal limits. Overnight the subject experienced one brief episode of twitching in the left arm, possibly due to location of his IV and arm board. His parents noted a "drastic improvement" following initiation of levetiracetam, and the subject was discharged on 13 December 2009 with orders for levetiracetam 10 mg/kg twice daily. An outpatient EEG, recorded in wake, sleep, and drowsy states, was performed on 04 January 2010. The neurologist's impression was that the test was abnormal, due to generalized slowing, focal spike discharges and focal sharp wave activity suggestive of generalized encephalopathy. Recommendations were clinical correlation, neuroimaging study, and referral for neurological consultation. A pediatric follow-up visit on 07 January 2010 noted a history of neonatal seizures with global hypoxic/ischemic injury, suggestive of global hypoperfusion. Examination revealed hypertonia in all 4 limbs, and slightly asymmetric hyperreflexia in the legs. He was found to be at high risk for developmental delays, and noted to have renewed seizures, partially controlled. The plan at that time was to increase levetiracetam to 1.5 mL twice daily and call if seizures continued. He was also to follow-up with the neurologist in 2-3 months. Per the investigator, "symptoms (seizures and hypertonia) continue and likely are permanent due to global hypoxic/ischemic injury". The event was considered to be ongoing. According to the investigator, the event was related to the study vaccine. Follow-up information was received from the investigator on 01 July 2010. The subject had been examined several days prior to vaccination, and had been weaned off KEPPRA several months prior without apparent problems. Per the investigator, the term seizure was an accurate diagnosis, however "this is a renewed seizure in a child with a previous history of seizures." Outcome remained ongoing. Documents held by sender: Physician notes, hospital records.