Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Coma, Convulsion, Dyspnoea, Eye disorder, Fontanelle bulging
Clinical narrative: Information has been received from a physician concerning a 9 month old male who on 07/01/00 was vaccinated with a third dose of Hepatitis B vaccine recombinant (yeast) (lot#008K [invalid lot number]) in the left thigh (route unspecified). On 07/03/00, the patient was vaccinated with a first dose of Streptococcus Pneumonae vaccine (Prevnar) (lot number unknown) intramuscularly in the left thigh. On 07/18/00 the infant developed a fever of 102F. He was treated with Ibuprofen (Motrin) and cool baths. On 07/21/00, in the AM, he had decreased activity and difficulty breathing; his fever was 103.4F and he vomited twice. He was seen by the physician who noted that the infant had a "blown pupil'. He was sent to the emergency room where he was "unresponsive, pupils were dilated and a seizure occurred." His heart rate and respirations were decreased. He was intubated; CSF (cerebrospinal fluid) cultures and blood cultures were drawn. Epinephrine and Norepinephrine were given with some recovery. He was transferred to the Ped's ICU where he again dropped his blood pressure and heart rate. He required CPR, followed by code drugs and defibrillation x 2. On 07/22/00 the child coded and died. Post-mortem tests revealed Streptococcus Pneumonae in the blood and CSF cultures. The cause of death was not reported. The reporter indicated that the "specimen was sent to the CDC (Center For Disease Control) where type 14 was present as in Prevnar." Additional information has been requested. This episode was previously sent to the FDA by Wyeth-Ayerst Research. Their manufacturer control number is HQ3264306Nov2000. Additional info received from the Center for Biologics Evaluation and Research on 1/22/01, indicated that on 7/20/00, the infant developed a facial rash. When the infant was seen by the physician on 7/21/00, he was noted to have forced respirations and a bulging fontanelle. EMS were called to transport the child to an ER. Follow-up: This report is being re-submitted because the code was changed to capture a more specific event event. A physician reported that a 9 month old male received an injection of Prevnar on 7/3/00. On 7/18/00, the infant developed a fever of 102 deg F. He was treated with Motrin and cool baths. On 7/21/00,his fever was 103.4 deg F and he vomited twice. He was seen by the physician who noted that the infant had a "blown pupil." He was sent to an ER where he was "unresponsive, pupils were dilated and a seizure occurred." His heart rate and respirations were decreased. He was intubated. On 7/22/00, the child coded and died. Post-mortem tests revealed Streptococcus pneumoniae in blood and CSF cultures. The reporter indicated that the "specimen as sent to the CDC where type 14 was present as in Prevnar." A copy of this report has been forwarded to manufacturer of Recombivax-HB. Additional info received from the Center for Biologics Evaluation and Research on 1/22/01 indicated that on 7/20/00, the infant developed a facial rash. When the infant was seen by the physician on 7/21/00, he was noted to have forced respirations, and a bulging fontanelle. Emergency services were called to transport the child to an ER. Follow-up info received from the Center for Biologics Evaluation and Research on 8/3/01 provided lot number 471/2149 for Prevnar. The lot number for Prevnar was reported as 471/2149; however, this is not a valid manufacturer lot number.