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Life Threatening? No
Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 4-year-old female patient who received BEXSERO (batch number ABX728AA, expiry date unknown) for prophylaxis. Concomitant products included nusinersen. On 19th October 2018, the patient received BEXSERO (unknown) 5 ml. On 19th October 2018 22:00, less than a day after receiving BEXSERO, the patient experienced hyperthermia (serious criteria death). On 19th October 2018 23:00, the patient experienced cardiac arrest (serious criteria death and GSK medically significant), death imminent (serious criteria death and GSK medically significant) and tachycardia paroxysmal (serious criteria death). On 19th October 2018, the outcome of the cardiac arrest, death imminent, tachycardia paroxysmal and hyperthermia were fatal. The patient died on 19th October 2018. The reported causes of death were cardiac arrest, tachycardia paroxysmal, hyperthermia and death imminent. An autopsy was not performed. It was unknown if the reporter considered the cardiac arrest, death imminent, tachycardia paroxysmal and hyperthermia to be related to BEXSERO. Additional information: The route of administration of BEXSERO was reported as Intravenous in the source document. Initial information was received from a physician via regulatory authority on 5th November 2018: Sudden hyperthermia at 10 PM, paroxysmal tachycardia followed by cardiac arrest and death at 11 PM. Reporter''s comments: Clinical report by the signaler: (as per regulations): ''The report refers to a four year old girl Patient affected by SMA Type 1, in integrated home care with chronic respiratory failure in VMI h 24, tracheostomy and PEG. Patient treated with NUSINERSEN given periodically by intrathecal route from 13/01/2017 at the hospital (last administration 14/07/2018). Administered to Patient (truncated sentence). Reported Cause(s) of Death: Cardiac arrest; Tachycardia paroxysmal; Hyperthermia; Death imminent.
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