Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Coma, Sudden infant death syndrome
Clinical narrative: Information has been received from an investigator concerning a 11 week old male with a recent history of an upper respiratory tract infection who entered a phase IV study. The child was born by c-sectino without complication one and one half weeks overdue. He was the second child, the older sibling is a 4 year old who suffers from asthma but is otherwise healthy. The child was seen by his pediatrician at two weeks and again at two months, on 11/18/02. His diet consisted of breast milk and ProSobee formula. He was described as having a very healthy appetite. He usually slept on his stomach and occasionally on his back and was able to lift his head and turn it from side to side. He was placed in residential day care on 11/13/02 at 8 weeks. There is a 4.5 month old at the day care and two other part time children, ages unknown. It was reported that the day care was unlicensed. On 11/18/02 was vaccinated with a dose of hepatitis B vaccine recombinant. This report was part of a post-marketing surveillance program. Concomitant therapy included a dose of HIB conjugate vaccine, a dose of pneumococcal vaccine 23 polyvalent, a dose of poliovirus vaccine, and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. ON 12/7/02 the patient suffered from a cold and congestion and was given acetaminophen cold drops for infants every eight hours. The patient's last dose was on the evening of 12/8/02. On 12/9/02 the patient was taken to the day care center at about 08:00AM (also reported as approximately 8:30). Four children total were being cared for by the day care operator. The child was given approximately 4/10 of a cc of infant acetaminophen (TYLENOL) due to his cold. He reportedly was placed face down for a nap per the mom's request at 9:30AM with a blanket covering him (also reported as on his side/stomach). He was stirring around 11:00am. The day care provider checked on him again at 11:30am (also reported as 11:45) and observed the decedent unresponsive. She called the emergency sevices and the decedent was transported to a medical center. A physician pronounced the death at 12:57PM. The decedent was brought to the coroner's office for examination and an autopsy was done on 12/10/02 at 10:00AM. At 1:40PM the coroner was contacted at the office by the investigator regarding the death of this 11 week old patient. The coroner contacted the investigator via telephone and informed him of the circumstances and agreed to meet him at the hospital. He arrived at the hospital at approximately 2:05PM and met the detective of the police department. The coroner was escorted to the examining room where the family was holding the baby. After the family was escorted out of the room the detective informed him the circumstances of the day. It was reported that the child was a well developed, well nourished appearing male infant. Rigidity was fully developed in the bilateral lower extremities and the right upper extremity, but appears to have been broken in the left upper extremity. It was fully developed at the jaw. Lividity is in a somewhat mixed distribution but somewhat heavier over his back with clearing over the pressure points. It blanches with pressure. The hands were clenched. Evidence of medical therapy is present including a left intraosseous pretibial catheter, a hospital identification bag at the right ankle, multiple EKG pads and defibrillator pads and an endotracheal tube present in the mouth. No signs of injury are noted on the child. The child is wrapped in a blanket and there is a clean appearing disposable diaper appropriately positioned. The genitals were unremarkable. No intraoral or ocular petechiae were noted. The fundi are examined with the ophthalmoscope present in the room and there is some haziness present but the vessels are seen in both eyes and no evidence of retinal hemorrhage is appreciated. The anterior fontanel is flat and non bulging. The head is normocephalic and shows no evidence of trauma. There are also a pair of socks present on the bilateral feet. Photographs are taken and the infant is undressed and the majority of the medical instrumentation is taken off and additional photographs are obtained. Following his examination he leaves the baby in the custody of the investigator, waiting for the arrival of another investigator. The coroner then departs the hospital for the scene at 2:40 PM. He arrives at the scene at approximately 2:55 PM. The scene is a single family dwelling which houses a residential day care. He is met by the day care operator and a member of the police department. He is showed to a back bedroom where there is a playpen with a single blanket on the bottom. Photographs are taken. The home contains several adults and children and is cluttered with numerous decorations, but is relatively clean. He is given the bottle which the day care operator said the infant consumed approximately 6 out of 7 ounces of ProSobee formula at approximately 8:30 AM. She subsequently had washed the bottle. An additional bottle of identical formula was provided along with the container of acetaminophen drops. These were turned over to the police department and the coroner departed the scene at approximately 3:10 PM. No evidence of injury or congenital malformation was found. Postmortem microbiology, toxicology, bacteriology, virology, biochemical testing, RSV test and genetic testing were negative. The prone sleeping condition was considered a significant condition and the manner of death was natural. The cause of death was reported as sudden infant death syndrome. The investigator causality is unknown at this time. Additional information has been requested.