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This is VAERS ID 845458

Case Details

VAERS ID: 845458 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-05
Onset:2017-10-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A21CC953A ? / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15112 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ammonia increased, Anion gap increased, Bacterial test negative, Biopsy liver abnormal, Blood bicarbonate decreased, Blood calcium normal, Blood creatine phosphokinase increased, Blood culture negative, Blood glucose increased, Blood lactic acid increased, Blood pH normal, Blood phosphorus normal, Blood potassium increased, Blood pyruvic acid increased, Blood sodium decreased, Blood uric acid increased, C-reactive protein increased, CSF glucose, CSF lactate, CSF protein, CSF virus no organisms observed, Coagulation factor V level normal, Death, Glucose urine absent, Hepatic failure, Hepatocellular injury, Metabolic acidosis, Nervous system disorder, Nitrite urine absent, PCO2, Platelet count increased, Polymerase chain reaction, Procalcitonin increased, Prothrombin level decreased, Transaminases, Urine ketone body absent, White blood cells urine negative, pH urine normal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-09
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20171008; Test Name: Anion gap; Result Unstructured Data: Test Result: 27, Test Result Unit: unknown; Test Date: 20171008; Test Name: Anion gap; Result Unstructured Data: Test Result: 17, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood bicarbonate; Result Unstructured Data: Test Result: 14, Test Result Unit: mmHg; Test Date: 20171008; Test Name: Blood bicarbonate; Result Unstructured Data: Test Result: 11, Test Result Unit: unknown; Test Date: 201710; Test Name: Blood bicarbonate; Result Unstructured Data: Test Result: 11, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood calcium; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood creatine phosphokinase; Result Unstructured Data: Test Result: elevated, Test Result Unit: unknown; Test Date: 20171007; Test Name: Blood culture; Result Unstructured Data: Test Result: Negative, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood glucose; Result Unstructured Data: Test Result: 2.67, Test Result Unit: g/L; Test Date: 20171008; Test Name: Blood glucose; Result Unstructured Data: Test Result: 12, Test Result Unit: mmol/L; Test Date: 20171008; Test Name: Blood lactic acid; Result Unstructured Data: Test Result: 54, Test Result Unit: mmol/L; Test Date: 20171008; Test Name: Blood pH; Result Unstructured Data: Test Result: 7.36, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood phosphorus; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood potassium; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 201710; Test Name: Blood potassium; Result Unstructured Data: Test Result: elevated, Test Result Unit: unknown; Test Date: 20171007; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: not decreased, Test Result Unit: unknown; Test Date: 20171008; Test Name: Blood sodium; Result Unstructured Data: Test Result: 132, Test Result Unit: mmol/L; Test Date: 20171008; Test Name: Blood uric acid; Result Unstructured Data: Test Result: 400, Test Result Unit: mcmol/L; Test Date: 20171006; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: degree C; Test Date: 20171008; Test Name: Coagulation factor V level; Result Unstructured Data: Test Result: 95, Test Result Unit: percent; Test Date: 20171007; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 120, Test Result Unit: mg/L; Test Date: 20171007; Test Name: Heart rate; Result Unstructured Data: Test Result: 190, Test Result Unit: bpm; Test Date: 20171008; Test Name: PCO2; Result Unstructured Data: Test Result: 3.3, Test Result Unit: KPa; Test Date: 20171007; Test Name: Platelet count; Result Unstructured Data: Test Result: 790000, Test Result Unit: /mm3; Test Date: 20171008; Test Name: Coagulation factor II level; Result Unstructured Data: Test Result: 63, Test Result Unit: percent; Test Date: 20171008; Test Name: Prothrombin level; Result Unstructured Data: Test Result: 67, Test Result Unit: percent; Test Date: 20171008; Test Name: Transaminases; Result Unstructured Data: Test Result: 5N, Test Result Unit: unknown
CDC Split Type: FRGLAXOSMITHKLINEFR201806

Write-up: Hepatic cytolysis; Failure liver; Neurological disorder NOS; Acidosis metabolic; This case was reported by a physician via regulatory authority and described the occurrence of hepatic cytolysis in a 4-month-old male patient who received DTPa (Infanrix) (batch number A21CC953A ?, expiry date unknown) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number S15112, expiry date unknown) for prophylaxis. On 5th October 2017, the patient received Infanrix (unknown) 1 dosage form(s) and PREVENAR 13 (intracardiac) 1 dosage form(s). On 7th October 2017, 2 days after receiving Infanrix, the patient experienced metabolic acidosis (serious criteria death and GSK medically significant). On 8th October 2017, the patient experienced hepatic cytolysis (serious criteria death and GSK medically significant), liver failure (serious criteria death and GSK medically significant) and neurological disorder nos (serious criteria death). On 9th October 2017, the outcome of the hepatic cytolysis, liver failure, neurological disorder nos and metabolic acidosis were fatal. The patient died on 9th October 2017. The reported cause of death was metabolic acidosis. An autopsy was not performed. It was unknown if the reporter considered the hepatic cytolysis, liver failure, neurological disorder nos and metabolic acidosis to be related to Infanrix. Additional details: The age at vaccination was not reported. However age at event was reported as 4 months. Initial information was received from a physician via regulatory authority on 16th April 2018: Failure liver, neurological disorder nos, hepatic cytolysis and acidosis metabolic. Follow up information was received from a duplicate case FR2018GSK084791 via regulatory authority on 14th May 2018: The reporter information updated. The patient''s historical conditions updated. The lab data updated. The event hepatic failure was updated to hepatic insufficiency. The vaccination date updated. The suspect infanrix was updated to infanrix hexa. Follow up information was received from a physician via regulatory authority on 01st Jun 2018: Lot number for infanrix hexa and prevenar 13 was added. Follow up information was received from a physician via regulatory authority on 30th October 2019: The infanrix hexa was change to infanrix. Note: The reported batch number for Infanrix was A21CC953A, based on batch number review, Infanrix hexa was identified as suspect vaccine. However suspect was kept Infanrix as reported. Lab Comments: On 8th October 2017 Ammnonemia 56 mcmol/L, Blood protide 52g/L On 7th October 2017 Procalcitonine 0.75 ng/ml 07 October 2017 -Clinical examination at emergency unit: painful child at palpation of vaccines injection sites ; no neurological abnormality. 08 October 2017 -Cerebral CT-scan: Hypodensities of the subcortical and subentemporal subcortical white matter without contrast enhancement, with no significant mass effect with lesions that appear to extend near the surface of the lateral ventricles.Cerebral arteries permeable without disparity of size and no sign of cerebral venous thrombosis. No sign of Intracranial hypertension. -Lumbar puncture: CSF protein at 1.07 g/L; CSF glucose at 6.1 mmol/L; CSF lactate at 4.7 mmol/L; 2 nucleated elements; no bacteria; detection of herpes virus in CSF negative. -Urine test strip: no ketonuria, no glycosuria, no leukocyturia, negative nitrite; urine pH at 5.5, urine protide ++. Parents refused an autopsy of their child. Considering the suspicion of a metabolic disease, complementary exams were performed; results were negative: -~Chromatography of plasma amino acids: decrease in citrulline related to gastrointestinal involvement with slight elevation of phenylalanine related to liver injury -~Chromatography of urinary organic acids: slight rise in lactic acid and pyruvic acid -~Normal acylcarnitine profile -~Hepatic biopsy showed moderate, isolated macro-vacuolar steatosis, with no specificity but which may be integrated in a context of mitochondrial cytopathy or other metabolic disease ; there was no inflammatory infiltrate or fibrosis and no significant iron overload. Respiratory chain exploration result. Muscle: -~Slight relative decrease in activity of complexes 1, 2, and 4 and strong activity of citrate synthase. -~DNA mitochondrial analysis by long range PCR : no large deletions in muscle -~Quantitative PCR analysis : no depletion of mitochondrial DNA -~Fibroblasts : normal activities -~Liver : normal activities -~Analys; Sender''s Comments: FR2018065408: Previous VAERS submission in paper format; Reported Cause(s) of Death: Metabolic acidosis


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