Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Choking, Convulsion, Cyanosis, Electroencephalogram normal
Clinical narrative: Pediatric medical records were received an reviewed concerning an 4 month old male baby patient with a history of mild respiratory distress syndrome, apgar score low, hyperbilirubinaemia neonatal, premature baby (reported as 31 weeks gestation, weighed 1675 grams), intubated after birth and small for dates baby (WAES # 0807USA01664) who on 28-AUG-2008 was vaccinated orally with the first dose of ROTATEQ vaccine (lot # 660877/0305X) and on 31-OCT-2008 was vaccinated orally with the second dose of ROTATEQ vaccine (lot # 661429/0594X), on the same day the patient was vaccinated intramuscularly with the first dose of PEDIARIX (lot # AC21B150AA), intramuscularly with the first dose of ACTHIB (Lot # UF442AA) and intramuscularly with the first dose of PREVNAR (lot #C45152). On 22-SEP-2008, baby's mother called because she was concerned due to baby turned head only one way. On 26-OCT-2008 a 4 month old male baby was examined. The baby who at 11:15 A.M., approximately 15 minutes after a feed, was noted to have milk incoming out of his nose. His face and his lips were purple and he had some stiffening and his eyes rolled back. This lasted less that a minute and then became a little bit sleepy afterwards. He vomited x1. When EMS arrived, he was awake and alert. this is the first episode like this, according to the parents. There is no other past medical history of significance except that he was a preemie that was hospitalized for difficulty with growing only. During review of symptoms was found that patient had rhinorrhea. Before physical examination the physician assessment was suspected seizure. On 31-OCT-2008 a 4 month old male baby was examined. The weight was 12 pounds and 6 ounces, the length 24.5 inches, head circumference 34 inches, temperature 98 F grades. The diagnosis reported was nasal congestion. On the same day the patient was vaccinated intramuscularly with the second dose of PEDIARIX (lot #AC21B150AA), intramuscularly with the second dose of PREVNAR (lot # C57963). Upon internal review, suspected seizure was considered to be an other important medical event. This is one of two reports received from the same source. Additional information is not expected. All medical records are provided upon request. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow-up information has been received from a medical assistant (pediatric office) concerning the results on an electroencephalography (EEG) that was scheduled for 05-DEC-2008, after a "suspected seizure" was noted on 26-OCT-2008, in the medical record of an emergency room visit for the baby. The medical assistant checked the chart and computer system and stated the baby did not have the EEG done on 05-DEC-2008, and it was scheduled for 14-JAN-2009. Follow up information received on 05-FEB-2009 stated that a phone call was placed to the physician's office; the certified medical assistant confirmed that the baby had the EKG, they received the results and it was a normal study. Follow-up information received from another physician who reported that on 14-JAN-2008, a 21 channel EEG was performed. No sedation was used for the EEG. The patient had a single episode of apnea and choking while feeding. The EEG began in the awake state with a background rhythm characterized by a mixture of low to medium amplitude theta and beta potentials, as well as significant (electromyogram) EMG artifact. An occipital rhythm was noted at 4-5 Hz. In the sleep state the background rhythm was characterized by a general attenuation with predominant rhythms of low to medium amplitude theta and delta potentials. Vertex waves and spindles were present. There were no epileptiform discharges noted. There was no focal of generalized slowing, and no symmetries were appreciated a convincing phobic driving response. The EKG revealed a regular rate and rhythm. Impression: "This was a normal awake and asleep EEG". Upon internal review, suspected seizure was considered to be an other important medical event. This is one of two reports received from the same source. This is an amended report. The information regarding the EEG that was received on 07-JAN-2009 was previously reported to the FDA on 09-JAN-2009 and 09-FEB-2009 in WAES#0807USA01664. The Batch number for PREVNAR was changed to C45152 in the therapy screen. Batch # for ACTHIB was also deleted. Additional information is not expected.