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This is VAERS ID 819148

Case Details

VAERS ID: 819148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-29
Onset:2019-05-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD251A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX790AB / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AD6190 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Condition aggravated, Death, Dyspnoea, Respiratory acidosis, Respiratory distress
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine; Furosemide; Amiloride hydrochloride; Lactulose; Captopril
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiolitis (In February 2019); Cough (Predated vaccinations); Foramen ovale patent; Ventricular septal defect (Born with, was repaired at 4 months of age)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201910

Write-up: Condition aggravated; Cardiac arrest; Respiratory acidosis; Respiratory distress; Breathing difficult; This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 5-month-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD251A, expiry date unknown) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number ABX790AB, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AD6190, expiry date unknown) for prophylaxis. The patient''s past medical history included cough (Predated vaccinations), ventricular septal defect (Born with, was repaired at 4 months of age) and bronchiolitis (In February 2019). Concurrent medical conditions included foramen ovale patent. Concomitant products included ranitidine hydrochloride (Ranitidine), frusemide (Furosemide), amiloride hydrochloride, lactulose and captopril. On 29th April 2019, the patient received Infanrix hexa (intramuscular) 1 dosage form(s), Bexsero (intramuscular) 1 dosage form(s) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 1st May 2019, 2 days after receiving Infanrix hexa and Bexsero, the patient experienced respiratory distress (serious criteria GSK medically significant) and breathing difficult. On 4th May 2019, the patient experienced cardiac arrest (serious criteria death and GSK medically significant) and respiratory acidosis. On an unknown date, the patient experienced condition worsened. On 4th May 2019, the outcome of the cardiac arrest was fatal. On an unknown date, the outcome of the respiratory distress, condition worsened and respiratory acidosis were unknown and the outcome of the breathing difficult was not recovered/not resolved. The patient died on 4th May 2019. The reported cause of death was cardiac arrest. It was unknown if the reporter considered the cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis to be related to Infanrix hexa and Bexsero. Additional information: The age at vaccination was not reported, however the patient could be 4 or 5 month old at the time of vaccination. It was unknown if the reporter considered the cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis to be related to Prevenar 13. The concomitant product reported as Nutritional supplement. Initial information was reported by a physician via regulatory authority on 12th June 2019: Cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis. Note: The reported current condition Cough was changed to historical condition as the patient was died.; Reported Cause(s) of Death: Cardiac arrest


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