Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hyperbilirubinaemia, Hypoglycaemia, Premature labour, Sudden infant death syndrome
Clinical narrative: Information has been received concerning a 9 week old male infant who on 10/10/01 was vaccinated with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). On 10/13/01, the infant was found dead in his crib. This was originally reported by a physician. Additional information has been requested. Follow-up info was received from a health professional who reported that the infant was premature at 34-35 weeks gestation. The patietn had hypoglycemia and hyperbilirubinemia in the nursery after birth which resolved by day 3 of age. The infant was reported to be healthy. The infant received haemophilus b conjugate vaccine hepatitis b vaccine recombinant. The infant also received a dose of Streptococcus pneumoniae vaccine and was found dead in his crib. The cause of death was not indicated. The pt's twin sibling received the same vaccines and at the time of the report, did not experience any problems. It was also reported that another infant also received both vaccines and died of sudden infant death syndrome. The physician's office reported that they did not believe there was any association with haemophilus b conjugate vaccine hepatitis b vaccine, but that both infants received the same lot of prevnar. No further info is available. A 15-day follow up report received 10/15/2003 adds: It was reported that a 2-month-old male pt was vaccinated with Tripedia and IPV (IPOL) on 10/10/2001. On 10/13/2001 the pt was found dead in his crib. From mailed correspondence received at the manufacturer on 06/20/2002 it was reported that the autopsy and cultures were all negative, cause of death reported as Sudden Infant Death Syndrome. From additional info from the Autopsy Report received on 10/01/2003 from the medical examiner, it was reported that the final diagnosis was consistent with Sudden Infant Death Syndrome, manner of death was reported as natural. The pt was found dead at 9:00 on 10/13/2001, the autopsy was done the following day at 11:50. The pt was a fraternal twin gestation. Reportedly, there were no witnesses at the time of death, the pt was in, apparent, good health and found dead in his car seat covered with a blanket. Postmortem findings are provided in the secion "Relevant Diagnostic tests/Laboratory data". Case file #U2002-00176 was received from the same reporter as case file #U2002-00029. After reviewing both case files, it was noticed that the original VAERS report update concerning case #U2002-00029 received on 12/30/2002 with handwritten additions and changes to the report referring to pt M.W. was mistaken for case #U2002-00029 instead of U2002-00176. The following is the info received at manufacturer on 12/30/2002: "The pt's birth weight (4 pounds, 15 ounces) was provided as well as the pt's medical history of "2nd twin, hyperglycemia, hyoerbilirubinemia, premature 35 weeks", number of siblings (1 twin brother, 1-half brother, 1-half sister), pt's address and the name of the vaccine administrator. Additionally, the pt's age at the time of the adverse event onset was corrected to 2 months." No further info is anticipated, this case is considered closed. A 15-day follow up report received 10/20/2003 adds: Follow-up on 10/01/2003, toxicology reports revealed "the blood (heart) screen-ABN = no drugs identified", blood (heart) screen GC volatiles = negative". Postmortem findings showed growth parameters appropriate for postnatal age, no congenital anomalies. Immature pulmonary and lymphoid development. Postmortem polymicrobial contamination of the lungs by enteric bacteria. No natural disease process identified, no electrolyte abnormalities identified and no traumatic injuries identified, no intoxicating drugs identified. Solid tissue mass in the right cheek - tissue diagnosis not attempted. The opinion of the medical examiner was that the 2 month and 5 day old male pt had no disease processes, developmental anomalies, injuries or drug intoxications that would be sufficient to cause cardioplumonary arrest. These findings were consistent with Sudden Infant Death Syndrome". External examination revealed that the body was that of a symmetrically developed, well nourished male whose appearance was consistent with the stated age of 2 months and 5 days. The body was a 54.0 cm long (75th percentile, adjusted) for birth at 35 6/7 weeks gestation) and weighs 4700 grams (50th percentile, adjusted). The crown rump length was 37.5 cm, the head circumference was 39.0 cm (75th percentile-90th percentile adjusted), the chest circumference was 38.5 cm, and the abdominal circumference was 39.5 cm. The anterior fontanel was prominent and incorporated the metopic suture. It was a 7 cm long, from front to back, and was maximally 2 cm wide at the coronal suture. The fontanel was slightly sunken. In the right cheek was a palpable firm indurated fixed mass. Oral mucosal injuries were not identified. The skull and facial skeleton were intact to palpation. The chest and abdomen were symmetrically formed. The chest was a normal diameter and had a normal infantile habitus. The internal examination revealed that there was no accumulation of fluid in either pleural cavity. The thoracic viscera had their normal anatomic locations and relationships. The pericardial sac contains approximately 2 cc of clear yellow fluid. The great vessells and chambers of the heart appear to have their normal anatomic configuration and relationships. There was no accumulation of fluid within the peritoneal cavity. The abdominal viscera had their normal shapes, locations and relationships. After removal of the organs from the body, inspection of the cavities revealed no evidence of fractures of the ribs, sternum, clavicles, vertebral column or pelvic bones. The subcutaneous fat on the anterior abdominal wall was 0.8 cm thick. Gross examination of the Organs: Organs of the neck: The tongue is atraumatic. There is no hemorrhage present in the soft tissues of the neck. The hyoid bone and laryngeal cartileges are not fractured. No obstruction of the upper respiratory tract is found. No fractures and or dislocations of the cervical vertebrae are detected. Heart: the organ has its normal arrangement of chambers and great vessels. The right ventricle is dilated. The coronary arteries have normal origins and anatomic distributions. No abnormalities are found in the leaflets, chordae or endocardium. There are no interatrial or interventricular septal defects. The foramen ovale is closed. Aorta: the aorta and its main branches are normally formed, the ductus arteriosus is closed. Lungs: The lungs have their normal anatomic shape and lobation. On cut section, the parenchyma is well-aerated and very congested. No obstruction of the tracheobronchial tree is found. No thrombi and or emboli are found within the pulmonary vessels. Liver: The organ has its normal anatomic shape, no traumatic lesions are found. Gall bladder and bile ducts: The gall bladder contains less than 1 cc of green viscid bile; the bile ducts are not obstructed. Spleen and lymph nodes: The organ has its normal anatomic shape, the sizes are unremarkable. Pancreas: The organ has its normal anatomic shape. Alimentary tract: No mucosal or mural lesions are found in the alimentary tract. Urinary tract: They have their normal anatomic shape. Abnormalities are found in the calcyces, pelves and ureters. The urinary bladder is normally formed and unremarkable. Central distribution. No atherosclerosis is present within the arteries. Venous vessels and sinuses contain only postmortem clot. On multiple coronal sections, no internal hemorrhage or other abnormality is found within the brain or brainstem. Microscopic description: The heart was found to be within normal limits. Lungs: The alveolar structures are focally immature, with wide hypercellular septa and remnants of hyaline membranes. They are irregularly ventilated. The lymphoid elements are very immature. Red blood cells are present in the alveolar spaces. Liver: no pathologic processes are identified. Kidney: Immature glomeruli are present in the superficial cortex. No pathological processes are identified. Lymphoid tissues: The pulmonary lymphoid elements are very immature. Microscopic examination of the larynx, pharynx, gastroesophageal junction, stomach, duodenum, terminal ileum, cecum, pancreas, prostate gland, parathyroid gland, thyroid gland, adrenal glands, diaphragm and brain (frontal cortex, basal ganglia, hippocampus, cerebellum, pons, medulla), confirmed the gross impression of tissues appropriate for chronological age. Pathologic processes are not identified. Toxicology results showed the blood (heart) screen-ABN = no drugs identified. Blood (heart) screen QC-Volatiles = negative. It was also reported that another infant (WAES #0201USA00430) also received Haemophilus B conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot #639444/0776L) and Streptococcus pneumoniae vaccine (Prevnar) and died of sudden infant death syndrome. The physician's office reported that they did not believe there was any association with Haemophilus B conjugate vaccine (+) hepatitis b vaccine recombinant (yeast), but that both infants received the same lot of Streptococcus pneumoniae vaccine (Prevnar) (lot #476-385). No further info is available. 15-day follow up reports received 10/22/2003 and 10/24/2003 add no new info.