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This is VAERS ID 799754

Case Details

VAERS ID: 799754 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-01-13
Onset:2018-10-19
   Days after vaccination:644
Submitted: 0000-00-00
Entered: 2019-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia, Sopor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tachipirina; NUROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mechanical ventilation; Percutaneous endoscopic gastrostomy; Tetraplegia; Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20181019; Test Name: Body temperature; Result Unstructured Data: Test Result: 37,4 international unit(s)-(under 100), Test Result Unit: iu; Test Date: 20181019; Test Name: Body temperature; Result Unstructured Data: Test Result: 39,5 international unit(s)-(under 100), Test Result Unit: iu
CDC Split Type: ITGLAXOSMITHKLINEIT201901

Write-up: Pyrexia; Sopor; This case was reported by a physician via regulatory authority and described the occurrence of fever in a 4-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included NUSINERSEN (SPINRAZA) for spinal muscular atrophy type i. The patient''s past medical history included tracheostomy, tetraplegia, percutaneous endoscopic gastrostomy and mechanical ventilation. Concomitant products included paracetamol (Tachipirina) and ibuprofen (Nurofen). On 19th October 2018, the patient received Bexsero (intramuscular) 1 dosage form(s). On 13th January 2017, the patient received SPINRAZA (intrathecal). On 19th October 2018, less than a day after receiving Bexsero, the patient experienced fever (serious criteria death) and sopor (serious criteria death). On 19th October 2018, the outcome of the fever and sopor were fatal. The patient died on 19th October 2018. The reported cause of death was pyrexia and sopor. It was unknown if the reporter considered the fever and sopor to be related to Bexsero. Additional details: On 19th October 2018 body temperature of patient was reported as 37,4 international unit(s)-(under 100) and 39,5 international unit(s)-(under 100) It was unknown if the reporter considered the pyrexia and sopor to be related to SPINRAZA. Initial information was received from a Physician via regulatory authority on 28th January 2019: On 19/10/2018, at 21 pm hyperthermia 37.3 ? C, administered tachipirina without benefit, BT arrived at 39.8 ? C, given nurofen without benefit, conditions worsened in about 2 hours, drowsiness and then death.; Reported Cause(s) of Death: Pyrexia; Sopor


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