Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Unknown. Died in sleep. The autopsy report received on 3/9/04 states SIDS. This report was received from the Center for Disease Control (CDC) in response to a request by GSK. This case was reported by the Center for Disease Control (VAERS number 211047) and described the occurrence of sudden death in a 4-month-old female patient who had received PEDIARIX. Medical history included premature birth at 32 weeks three days gestation to a 33-year-old gravida 4 para 4 female. The mother had a previous premature delivery and used tobacco. During this pregnancy, there was no prenatal care until three days prior to delivery. Pregnancy was complicated by twin gestation, premature onset labor, had untreated group B streptococcal infection. The patient was a twin delivered by urgent cesarean section with a birth weight of 1.835 kilograms. The patient's first cry was at 23 seconds and was followed by apnea; the "initial heartrate was less than or equal to 60 beats per minute. The apnea and bradycardia responded immediately to positive pressure ventilation and supplemental oxygen, which were discontinued within two minutes thirty seconds. Apgar scores were 4 and 9 at 1 and 5 minutes, respectively. The patient was admitted to the neonatal intensive care unit (NICU) with diagnoses of prematurity and possible sepsis. The 13-day NICU course was complicated by: 1) blood cultures that grew coagulase negative Staphylococci; this was treated with ampicillin and gentamicin; sepsis was subsequently ruled out. 2) hyperbilirubinemia (maximum serum total bilirubin 10.3 mg/dL) which was treated with two days of phototherapy. 3) Hypoglycemia, treated with intravenous fluids (04 through 08 June 2003), and gavage feedings (08 through 13 June 2003). The infant was discharged home on 16 June 2003. The infant was reported healthy when seen by the pediatrician for well-child care on 23 June 2003. On 25 July 2003, the neonate was examined for cough and several nasal congestion that had persisted for three days duration, and had improved following nasal suctioning. It was noted that both parents smoked and that the patient's symptoms were attributed to second-hand smoke. On 01 August 2003, the patient was reportedly improved. It was noted that, during the previous visit on 25 July 2003, the physical examination revealed tachycardia (heart rate of 212 without color changes) and decreased oxygen saturation (pulse oximetry in the "low eighties"), with subsequent improvement (heart rate to 180's and pulse oximetry of 100). It was noted that the parents had been counselled about not smoking in the house or car, and the importance of back sleeping was discussed "as babies have several risk factors for SIDS". The patient received initial vaccinations with PEDIARIX, PRENAR, and haemophilus influenza type b vaccination. Assessment included prematurity, passive smoking, and tachycardia with referral to cardiology for first available appointment for evaluation. On the afternoon of 09 October 2003, the patient received her second dose of PEDIARIX (lot number 21893B9). At the time of vaccination, the patient's heartrate was 136 beats per minute, respiratory rate of 32 per minute, temperature 97.3 degrees Fahrenheit, weight 15.88 pounds. The patient was noted to be "smiling, playful, no distress". Co-administered vaccinations on that date included PREVNAR (Lederle Labs) and PEDVAXHIB (Merck). One day after vaccination, on the morning of 10 October 2003, the patient died in her sleep. Autopsy reported the cause of death as Sudden Infant Death Syndrome. (report not available). Further information about the circumstances of death are not available.