Age: 0.15
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Unresponsive to stimuli, Urinary casts present, Urine leukocyte esterase positive, Urine output decreased, Urobilinogen urine increased
Clinical narrative: Information has been received from an investigator concerning a 57 day old male with no medical history or concurrent conditions who entered a study. The subject was reported to be the product of full term pregnancy, all prenatals were negative as reported by subject's mother and there were no complications post delivery. On 25-JAN-2012 the subject was randomized to be vaccinated with DTaP-HepB-Hib-IPV at 2, 4 and 6 months of age. On 25-JAN-2012, the subject was vaccinated with the first 0.5 IM dose of DTaP-HepB-Hib-IPV (injection site were not reported), other study vaccine therapy included the first 2 ml po dose of ROTATEQ and the first 0.5 ml IM dose of PREVNAR 13 (injection site not were not reported) to complete the childhood immunization series. There was no concomitant medication. Past drug therapy included the first dose of RECOMBIVAX HB on 01-DEC-2011. On 26-JAN-2012 the patient experienced fever (intensity severe) and sepsis (intensity severe) and was hospitalized. On 25-JAN-2012, prior to the first dose of study vaccination, the subject's vital signs were temperature of 98.4 (unit of measurement not reported), HR was 126, RR was 26. A thorough physical exam was done and the subject's parents reported no symptoms or complaints of any "issues or concerns". On 27-JAN-2012 at 02:00 (previously reported as 14:00), the subject was admitted to the PICU in cardiac arrest with fever (temperatures not reported), questionable seizures. The subject was intubated on ventilator, placed on vasopressors, dopamine and epinephrine (dose, route and duration not reported) and was reported to be severely acidotic. The subject had the following lab results on 27-JAN-2012 at 03:24 WBC 18.5, RBC 2.82, Hgb 8.7, Hct 27, Platelets 242, MCV 95.5, MCH 30.7, MCHC 32.1, MPV 10.7, Man Segs 8, Man Bands 41, Man Lymphs 38, Atyp lymph Man 2, Man Metas 6. On 27-JAN-2012 at 03:30 Urinalysis blood large, protein greater than 300, protein sulfosal 4 plus, urobilinogen 0.2 leukocyte esterase small, WBC 10 to 25, bacteria few, amorphous urate crystals few, granular casts rare. On 27-JAN-2012 at 04:20 WBC 12.4, RBC, 2.63, HGB 8.1, HCT 24.1, Plts 131, MCV 91.9, MCH 30.9, MCHC 33.6, MPV 10.4, man Segs 11, man Bands 44, man Lymphs, 37, man metas 4, burr cell few, sodium 140, potassium 7.5, CO2 9, glucose 14, BUN 38, creatinine 1.43, calcium 6.5, albumin 1.8, globulin 2.6, ALT 192, AST 494, lactic acid 10.2. On 27-JAN-2012 at 11:30 sodium 140, potassium 9.2, CO2 7, glucose 24, BUN 41, creatinine 1.61 and calcium 6.1. On 27-JAN-2012 at 14:00 lactic acid greater than 22.2. On 27-JAN-2012 at 15:30; WBC 1.1, RBC 1.86, Hgb 5.7, Hct 17.2, Plt 49, MCV 92.8, MCH 30.7, MCHC 33.1, MPC 9, ABS Neut 0.6, ABS lymphs 0.5, neutrophils percentage 53, man segs 20, man lymphs 80, Burr cells moderate, sodium 152, potassium 5.8, CO2 11, glucose 67, BUN 42, creatinine 1.8, calcium 4.9, phosphorus 15.1, magnesium 3. On 27-JAN-2012, the preliminary blood cultures were reported as positive for group A streptococcal bacteremia (not reported as SAE, NSAE or symptom), respiratory culture was normal oropharyngeal flora and gram stain no organisms seen, influenza A/B antigen no virus detected, RSV direct antigen was negative. On 27-JAN-2012 at 19:15 pm, the subject died (previously reported as approximately 16:00). The reporting investigator reported that the clinical picture of seizures, acidosis, cardiac and respiratory arrest were considered to be a "by product" with either or both fever and/or sepsis. The cause of death was reported as sepsis, the investigator no longer considered fever as a cause of death, as previously reported. An autopsy was performed on 29-JAN-2012 at 0800 (previously reported as unknown) by the county coroner. Final report on 08-MAR-2012 reported the immediate cause of death was sepsis due to or as a consequence of bacteremia due to or as a consequence of streptococcus pyogenes Group A. The autopsy report revealed the following information: The subject presented to the emergency room (ER) on 27-JAN-2012 at 0309, the subject had been febrile during the evening and one hour prior to arriving at the ER, and the subject's temperature was 101.6 degrees. While at home, the subject's mother witnessed the subject's eyes roll back in the head, had poor color and agonal respiratory effort. The subject's parents drove the subject to the hospital because they had not been responding well. There were no sick family members at home. The subject's mother reported the subject was vaccinated on 26-JAN-2012 (investigator confirmed date of vaccination was 25-JAN-2012). The subject was in cardiac arrest when brought into the ER. The subject's father stated the subject had shallow breaths and stopped breathing in the hospital parking lot. At 0312, the subject had a pulse of 140, respiratory rate was being assisted at 17 and a rectal temperature was 102.3F. At 0320, subject was intubated, at 0341, blood and urine cultures were obtained. The physician documented that the subject had purpuric injury to the skin probably related to perfusion. The initial diagnoses were severe anoxic injury, multiple organ damage and anoxic encephalopathy. At 0423, the subject left the ER. The subject was admitted to the pediatric intensive care unit and remained comatose. Vasopressors were required, the subject had minimal to no urine output and became coagulopathic. The subject's condition was discussed with the parents and they agreed to allow a "natural death". The subject was removed from the ventilator and died at 1915 on 27-JAN-2012. Physical findings noted the following: weight 6500g (97 percentile), crown-heel measurement 59cm (75 percentile), abrasions on knees (not an SAE), generalized ecchymosis on chest (related to sepsis), generalized red rash/mottling on entire body (related to sepsis), small umbilical hernia (not an SAE), erythematous on labial frenulum (not an SAE), mainstem bronchi noted to have inflammation, pleural cavities noted to have scant fluid, lungs noted to have moderate diffuse congestion and moderate edema, pituitary reported as abnormal (not further specified). Final anatomic diagnoses were generalized purpuric rash probably related to perfusion (related to sepsis), focally crusted, no significant trauma and bilateral pneumonia-cultures positive for streptococcus pyogenes group A. Slides dated 30-JAN-2012, sections of lungs, liver, spleen and kidneys showed collections of polymorphs consistent with septic state, frank pneumonia was not recognized. Slides dated 13-FEB-2012 sections of brain and meninges were unremarkable. Toxicology report collected on 21-FEB-2012, cardiac blood, was positive for acetaminophen 9.1 mcg/ml. The investigator considered fever and sepsis to be immediately life-threatening and to be disabling. There was no action taken with study vaccine therapy. The reporting investigator felt that fever was possibly (previously reported as probably) related to study therapy and that the sepsis was probably not related to study therapy. Follow-up information was received from the investigator on 30-JAN-2012, the following fields were updated: therapy, AE/Therapy information and the narrative. Follow-up information was received on 01-FEB-2012 from the investigator, the following fields were updated: AE information, labs/diagnostics and narrative.  Follow-up information was received on 03-FEB-2012 from the investigator, the following field was updated: narrative. Follow-up information was received on 28-MAR-2012 from the investigator, the following fields were updated: demographics and narrative. Follow-up information was received on 10-APR-2012 from the investigator, the following fields were updated, labs/diagnostics and narrative. Follow-up information was received on 04-MAY-2012 from the investigator, the following field was updated: narrative. Additional information is not expected. This is an amended report it was requested to remove Disability from SAE of sepsis; Relationship to ROTATEQ and PREVNAR 13 for Fever as related; Relationship to ROTATEQ and PREVNAR 13 for sepsis as not related.