Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test abnormal, Sudden infant death syndrome
Clinical narrative: This subject is a 3 month old male, who died while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants as a booster to toddlers, Protocol number P3T08. The subject received one dose of Pediarix vaccine, ACTHIB, PRevnar. The last dose prior to the event was given on 8/5/03. The subject died 45 days post-immunization. The event of SIDS was reported by the investigator as not related to the study vaccine. The pathology report states that the subject was pronounced dead at 2346 hours of 9/19/03. The disease or condition directly leading to death is consistent with sudden infant death syndrome. Anatomical diagnoses: 1) Petechial hemorrhages, heart, lungs. Thymus; 2) No congential anomalies; 3) Pulmonary congestion and edema and 4) Visceral organ congestion. The autopsy report states body appearing the stated age of 3 months. Evidence of medical therapy is present: 1) an interosseous needle present in the left thigh. At the time of the autopsy exam, the needle has come out of the thigh. In addition, there is a second apparent needle puncture mark in the same location; 2) an oral tracheal tube secured around the neck by tape; 3) an electrical monitoring device taped to the right big toe; and 4) multiple cardiac monitoring pads over the torso. There are no blunt injuries to the body. Fontanelles are flat. Statures are moveable. Present in the right occipital area about two inches above the ear, is a 1/2 inch red defect consistent with a hemangioma. Pupils are round. Irides are brown. Sclerae are white. No petechial hemorrhages are noted. Ears, nose and lips are non remarkable. Neck is normal. Chest is flat. The breasts are consistent with an infant male. The umbilicus is well-healed. The abdomen is flat. The external genitalia are non remarkable. Legs and feet are normal. Each foot and hand has five digits. No simian folds are present. The back is non remarkable. The anus is perforated and surrounded by yellow-brown fecal material. Internal examination: Body cavities-the pleural cavities, pericardial cavity and peritoneal cavity are lined by smooth, glistening surfaces and contain no fluid. Ribs and diaphragms are intact. No traumatic injuries are present. Oragns are in their proper locations. Heart-a small number of petechial hemorrhages are present on the epicardial surface. No areas of necrosis are present. Chambers and valves are normal. The coronary system is normal. The ventricular septum is completely formed. The foramen ovale is closed. Thymus-a small number of petechial hemorrhages are present on the surface. Trachea and bronchi-No T-E fistula is present. Lungs-a small edematous. No consolidation or infarcts are present. Airways of both lungs are normal. Liver-the parenchyma is brown and congested. Spleen-no trauma is present. Adrenal glands-normal size, no hemorrhages or tumors present. Neck-the hyoid bone and laryngeal structures are intact. Soft tissue about the larynx is normal. The larynx is free of obstructing material. The oral cavity, esophagus, stomach, intestines, gallbladder, pancreas, kidneys, bladder, prostate, musculoskeletal system and central nervous system are all normal. Microscopic examination: Lungs-sections show non remarkable airways and alveolar spaces. No inflammatory infiltrates are identified. Heart-sections show non remarkable appearing myocardial muscle cells. No inflammation or scarring is identified. Brain-sections show no histological abnormalities. Pancreases-sections show non remarkable exocrine and endocrine structures.