Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal distension, Abdominal tenderness, Acute hepatic failure, Adenovirus test positive, Ammonia increased
Clinical narrative: This report was received from the Centers for Disease Control via healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of liver failure in a 3-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR (non-GSK) (Wyeth) and ROTATEQ (non-GSK) (Merck). On 12 November 2008 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of PREVNAR (unknown), unspecified dose of ROTATEQ (unknown). On 14 November 2008, 1 day after vaccination with PEDIARIX, PREVNAR and ROTATEQ, the subject experienced vomiting and, irritability. Two days after vaccination with PEDIARIX, the subject experienced seizure. At an unspecified time after vaccination with PEDIARIX, the subject experienced liver failure, trisomy 21, vomiting, dehydrated, lethargy, glucose abnormal, metabolic syndrome, renal failure, coagulopathy, cerebral edema, fulminant enzymes, anemia, respiratory failure, anasarca, jaundice, elevated ammonia, abdominal distension and tender abdominal area. The subject was hospitalized. The subject was treated with TYLENOL, intravenous fluid(s), insulin (Insulin drip), red blood cells (PRBC), blood products, intubation, hemodialysis and parenteral nutrition. The subject died on 8 December 2008 from liver failure and trisomy 21. It was unknown whether an autopsy was performed. It was reported that the subject was taken to local clinic on 14 November 2008 and seen by a private physician. It was reported the subject had been vomiting and wad dehydrated, no fever. The subject was treated and sent home. The subject returned to local emergency room (ER) on 15 November 2008 and was transferred to hospital. From there subject was transferred to another hospital. 12 January 2009: Death certificated stated cause of death was liver failure and trisomy 21. Hospital medical records were reviewed for 03 to 08 December 2008 final diagnosis was severe metabolic syndrome including trisomy 21, renal failure, kidney failure, coagulopathy and cerebral edema. Records reveal the subject had steady down hill course after transfer and expired on 08 December 2008. Death certificate was included with medical records. 07 January 2009: medical records from 16 November 2008 to 02 December 2008 were reviewed. Final diagnosis was idiopathic fulminant hepatic failure; multiorgan failure including liver and kidneys, encephalopathy, coagulopathy. Records reveal subject experienced vomiting day after vaccination then irritable and continued vomiting next day and became lethargic. Family treated the subject with TYLENOL in correct dosing regime. The subject was unable to tolerate feedings and taken to outlying hospital emergency room on 14 November 2008. Diagnosed with seizure and glucose of 15. Treated and transferred to outlying hospital. Glucose and liver enzyme remained high. Diagnosed with fulminant hepatic failure, anemia and coagulopathy. Treated with intravenous fluids (IVF), insulin drip, packed red blood cells (PRBCs) and blood products. Developed respiratory failure and was intubated. Transferred to higher level of care. On admission had anasarca, jaundice and elevated ammonia. Total parental nutrition and continuous venovenous hemodialysis was started. Gastrointestinal, metabolic, and neuro consults done. Mitochondrial disorder suspected. Liver and right thigh muscle biopsy revealed metabolic disorder and necrosis. Deemed not to candidate for transplant. Dialysis stopped, extubated and transferred as do not resuscitate (DNR) to hospital closer to family. 05 December 2008: received hospital medical records of 16 November 2008 to 02 December 2008, which consisted only of operative report and labs. Operative report indicates subject with fulminant hepatic failure, coagulopathy, and renal failure.