Age: 0.43
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Faeces discoloured, Injury, Irritability, Lethargy, Lung disorder
Clinical narrative: Initial report received from a consumer's parent on 10 December 2010. A 5-month-old female infant received on 10 November 2010 at 11:00 AM an intramuscular right thigh injection of INFLUENZA VACCINE, manufacturer provided as sanofi pasteur (lot number not reported) and died eight days later. The patient had no medical history, took no concomitant medications, no previous illness and had no illness at the time of vaccination. On 10 November 2010 in the evening, the patient developed a fever which was as high as 102 (units not provided). Over the next few days, the patient developed irritability, lethargy, diarrhea and loss of appetite. The patient was seen by a physician four days after the vaccination. The patient died on 18 November 2010. The outcome was reported as fatal. Follow-up information was received from a health care professional on 18 January 2011. The patient was seen in the physician's office on 15 November 2010 for the symptoms of irritability, lethargy, diarrhea, appetite loss and fever. The physician felt the patient had right otitis media and viral diarrhea. The patient had stool study done (unknown date) which was negative. The patient had received the following vaccinations on 19 October 2010: oral ROTATEQ (dose 2) Merck lot number 05192, a left thigh intramuscular injection (dose 2) of DAPTACEL, lot number C3514BA, a left thigh intramuscular injection (dose 2) of ACTHIB, lot number UH163AB (Foreign lot number E0893-1) and a right thigh intramuscular injection (dose 2) of IPOL, lot number E0204. On 10 November 2010, the patient received a left thigh intramuscular injection (dose 1) of FLUZONE, lot number U3788AA and a left thigh intramuscular injection (dose 2) of PREVNAR 13, Wyeth lot number 914513. The patient's birth weight was reported as 8 pounds. The outcome remained fatal. Follow-up information was received from a health care professional on 23 February 2011. The lot number of the ROTATEQ vaccine was corrected to 0519Z (previously reported as 05192). The outcome remained fatal. Follow-up information was received from a health care professional on 23 March 2011. The patient had received treatment and was given prescriptions at the physician's office on 15 November 2010 (exact treatments were not reported). The patient did not require hospitalization for the event. According to the reporter the patient was at a daycare facility and had been put down for a nap at 1330 pm on 19 November 2010. At 1510, the patient was checked on and was found to be gray in color and not breathing. CPR was initiated and the patient was transported to the emergency department. The patient was pronounced dead at 1609 pm on 19 November 2010 (also reported as 18 November 2010). Follow-up information was received from a health care professional on 01 April 2011. The reporter provided contact information for obtaining a copy of the patient's autopsy report. No further information was provided at the time of the report. Follow-up information received from a health care professional on 09 May 2011 provided the patient's chart note for the 15 November 2010. The patient was seen by a physician on 15 November 2010 with the complaint of a temperature on and off since getting the influenza vaccine 6 days ago. The patient's temperature was 100.1 rectally and her body weight was 14.1 (units not reported) at the time of the visit. The patient had been sleeping terrible, had been cranky, had diarrhea for 6 days and had a decreased appetite. The temperature maximum (Tmax) was to 101 degrees since last week. The patient had daily temperatures that reduced with TYLENOL. The patient attended daycare. It was unsure if the patient's wets were within stools. The patient had diarrhea 2 every change approximately 6 green, watery loose stools with no blood in the stools. The patient was alert with the following being reported as normal: head, eyes, nose, throat, neck (supple), heart/pulses, lungs (clear to auscultation (CTA)), skin (warm, turgor, elastic, pink, well profused), ears (TM right red, dim and TM left gray). The patient was treatment included with amoxicillin 400/5 - 3 milliliter (ml) oral (po) twice a day (BID) x 10 days, fluids (1-2 ounces PEDIALYTE) for clear watery stool, and CULTURELLE one capsule 2-3 times a day. The patient's mother was to bring stools for culture, ovum and parasite, rotavirus, salmonella, shigella, cryptosporidium, and giardia. The patient was diagnosed with diarrhea viral and right tympanic otitis media (TOM). On 16 November 2010, the mother was called for a progress call and reported that the patient had no fever today. Supportive care by phone was given. The outcome remained fatal. Follow-up information was received 17 May 2011 from the medical examiner which consisted of an autopsy report. Additional follow-up information was received 18 May 2011 from the patient's physician, and from the medical examiner's office confirming the patient died on 18 November 2010 (noted as 10 November 2010 in the autopsy report). According to new information received, the patient was a five month old female who had no medical history except for a recent ear infection and diarrhea, and recent flu shot and strep-pneumo vaccine on 10 November 2010. The patient was at day care on 18 November 2010 at approximately 1330 to 1400 hours when she was found last seen alive and put down for a nap in a car seat lying on a bed with a blanket covered over her head. She arrived at daycare at approximately 8 to 9 AM, and was put down to sleep at 1330 hours. She was checked on because of her history of diarrhea and her diaper was checked. She seemed to be fine. At 1510 hours, she was checked again and was discovered to be gray in color and not breathing according to the day care provider. CPR was started and emergency personnel arrived at the scene and she was transported to the hospital at 1545 hours and was pronounced at 1609 hours. Reportedly, the care facility was not licensed and appeared unclean to the investigator. In addition, there were three other children in the home at the time of the incident. The external examination was performed on 19 November 2010 at 0830 hours. The patient was well developed and well nourished; body weight 6540 grams (at 25th percentile) and she had a crown heel length of 25 inches (at 75th percentile). A 3/4 x 1/16 inch horizontal linear abrasion on the posterior left thigh was noted. All other external findings were normal with no evidence of injury to the head, neck, thorax, abdomen or upper extremities. Internal examination findings were noted for the following systems. The head (central nervous system) noted slight diffuse cerebral edema; cerebral spinal fluid was clear. Remainder of findings for the head were not unusual and noted as unremarkable and intact. Cardiovascular system revealed petechial hemorrhages over the heart surface. The ductus arteriosus was anatomically and functionally closed. The remainder of cardiovascular findings were noted as unremarkable, not unusual, patent and intact. Respiratory system: right and left lungs weight 39 (38) and 36 (35) grams, respectively. There were large air-filled sacs measuring up to 6x4x4 cm in greatest dimension, probably secondary to CPR. Upper and lower airways were clear of debris and foreign material. The pulmonary parenchyma was dark red-purple, exuding slight to moderate amounts of blood and frothy fluid, with no focal lesions noted. Mucosal surfaces were smooth, yellow-tan and unremarkable. The pleural surfaces were smooth, glistening and unremarkable. Pulmonary arteries were normally developed and patent. Lower airway was unremarkable. Alimentary tract had normal findings; but also noted the gastric mucosa was arranged in the usual rugal folds, and the lumen contained 3 ml of white curdles liquid. Genitourinary Tract: the right and left kidneys weigh 22 (25) and 25 (25) grams, respectively. The cortical surfaces were smooth, red-brown and lobulated. The cortex was sharply delineated from the medullary pyramids. There were petechial hemorrhages and congestion of the cortical surfaces. Calyces, pelvis and ureters were unremarkable. Urinary bladder was empty. The mucosa was gray-tan and smooth. The Rediculoendothelial System noted spleen weight of 33 (16) grams with a smooth, intact capsule covering red-purple, moderately firm parenchyma. Lymphoid follicles were unremarkable. Regional lymph nodes were prominent, but not unusual for age. Bone marrow was red-purple and homogenous, without evidence of focal abnormality. Thymus was unremarkable weight 27 (13) grams. There were air-filled sacs present in the inferior surface up to 3 cm in greatest dimension. Internal examination did not reveal any abnormal findings for the neck, liver and biliary, endocrine and musculoskeletal systems. No evidence was collected or preserved. Total body radiographs showed no evidence of injury or natural disease. Initial radiology report indicated left frontal fracture; however, there was no craniocerebral injury seen at autopsy. Following autopsy, additional x-rays were performed showing no fractures. Microscopic Description: Liver - extramedullary hematopoiesis, Lungs - focal infiltrates of acute and chronic inflammatory cells, Esophagus - submucosal lymphocytic infiltrates, Stomach - lymphocytic infiltrates in lamina propria, and Cerebellum - persistence of the external granular layer. Heart, Kidneys, Spleen, Thymus, Pancreas, Adrenals, Trachea and Brain were negative, Thyroid - none. It was the opinion of the medical examiner that the patient died as a result of positional asphyxia. She had a recent history of diarrhea and ear infections. She was found dead seated in an infant car seat with her face pressed into the cushion and her head covered by a blanket. Autopsy revealed no evidence of trauma and microscopic sections showed bronchopneumonia. Toxicology results were negative. Vitreous electrolytes were unremarkable. X-rays were negative. Lung cultures were positive for Staphylococcus and Streptococcus. The right middle ear culture grew Streptococcus and the left middle ear culture grew Neisseris and Moraxella. Blood cultures were positive for Streptococcus. Viral cultures were negative. Pathologic diagnosis were as follows: 1. Positional asphyxia a. History of face turned into cushion of car seat with blanket over head - unsafe sleeping environment. b. Petechial hemorrhages of heart epicardium and bilateral kidney cortices. c. Diffuse cerebral edema. 2. Otitis media a. See ear culture report. b. History of 9 day ear infection and diarrhea since 15 November 2010. 3. Bronchopneumonia with possible sepsis a. See lung and blood culture. b. Splenomegaly. 4. Flu shot and strep-pneumo vaccine received on 10 November 2010. 5. No craniocerebral injury. Cause of death: Positional asphyxia. Other significant conditions: Bronchopneumonia and otitis media. Manner of death: Accident. Documents held by sender: Autopsy report.