Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Hypotonia, Ileus, Intensive care, International normalised ratio increased, Mechanical ventilation
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 360138) in response to a Freedom-of-Information request by GSK" and described the occurrence of trouble breathing in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX, (non-gsk) ACTHIB and (non-gsk) PREVNAR. Concurrent medical conditions included inguinal hernia and pneumonia. On 2 September 2009 the subject received unspecified dose of PEDIARIX (unknown), unspecified dose of ROTARIX (unknown), unspecified dose of ACTHIB (unknown), unspecified dose of PREVNAR (unknown). On 3 September 2009, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTARIX, the subject experienced trouble breathing, seizure, status epilepticus, white matter abnormality, gliosis, bladder hemorrhage, hemosiderosis, bronchopneumonia, tracheitis, mrsa, citrobacter infection, abdominal compartment syndrome. peritonitis, respiratory failure, intractable epilepsy, anoxic brain injury, encephalopathy, hypotension, urinary tract infection, hiccups, abnormal movement, sunken fontanelle, tachycardia, hypotonia, erythema, coma, breakthrough seizure, metabolic acidosis, ileus, csf test abnormal, cytogenetic analysis abnormal, international normalized ratio increased, cerebrospinal fluid protein and death nos. A 3-month old subject received multiple vaccines including PEDIARIX, ACTHIB, PREVNAR, and ROTARIX during well child visit on 02 September 2009. On 03 September 2009, he was brought to clinic by his mother with complaints of "trouble breathing". When the physician came into the room, the infant was noted to be seizing. A complete blood count, complete metabolic panel, atrial blood gas and urine samples were collected. He was diagnosed with Status Epilepticus and taken to a hospital where he was admitted to intensive care unit (ICU). A computed tomography (CT) and magnetic resonance image (MRI) were completed. Electroencephalogram  (EEG) demonstrated left temporal focus; herpes simplex virus (HSV) PCS and culture were negative; the initial screen was insufficient, repeat infant screen, ID and genetic consults were pending. On 25 January 2010, autopsy report was stated: "date of death 05 October 2009. Final anatomic diagnosis: 1) four-month old male infant without external anomalies. 2) Extensive white and gray matter loss with gliosis; most severe in the cerebral cortex. 3) Bladder hemorrhages with hemosiderin. 4) Bronchopneumonia. Additional information abstracted: subject was admitted to hospital approximately one month before death with intractable seizures, status epilepticus. Developed MRSA tracheitis, citrobacter urinary tract infection (UTI), abdominal compartment syndrome and peritonitis. On 25 January 2010, hospital records, discharge summary and multiple consultations reported service dates 03 September 2009 to 05 October 2009. Discharge diagnoses: 1) Respiratory failure secondary to status epilepticus. 2) Intractable epilepsy (uncertain etiology) 3) Anoxic brain injury causing encephalopathy. 4) Hypotension requires vasopressors. 5) Abdominal compartment syndrome. 6) Ileus. 7) MRSA tracheitis. 8) Citrobacter UTI. Parents noted abnormal leg movements, hiccups, diffuse abnormal jerking so infant was brought to emergency room, transferred from local emergency room to this facility with status epilepticus. Anterior fontanelle sunken, tachycardia with thread pulses. Generalized hypotonic, erythematous scaling yellow patch on right neck. Placed in phenobarbital coma, breakthrough seizures, intubated, mechanical ventilation. Metabolic acidosis. Ileus, abdomi". A computed tomography (CT) was abnormal; magnetic resonance image (MRI) was abnormal; electroencephalogram (EEG) was abnormal with left temporal focus; chest x-ray was abnormal; abnormal x-ray was abnormal. The subject was hospitalised. The subject was treated with vasopressor, phenobarbitone, intubation and mechanical ventilation. The subject died on 5 October 2009 from death nos. An autopsy was performed, A computed tomography (CT) abnormal; magnetic resonance image (MRI) abnormal; electroencephalogram. (EEG) - abnormal with left temporal focus; chest x-ray abnormal; abdominal x-ray abnormal. Herpes simplex virus (HSV) PCS negative.