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Life Threatening? No
Write-up: This case was reported by a physician via call center representative and described the occurrence of cardiopulmonary arrest in a 5-month-old male patient who received BEXSERO (batch number ABX776AA, expiry date July 2020) for prophylaxis. Additional patient notes included none. Concomitant products included INFANRIX HEXA, SYNFLORIX, Rotavirus vaccine, BEXSERO, INFANRIX HEXA, SYNFLORIX and Rotavirus vaccine. On 19th November 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 20th November 2018, 1 days after receiving BEXSERO, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant), cyanosis (serious criteria death) and rigidity (serious criteria death). On an unknown date, the outcome of the cardiopulmonary arrest, cyanosis and rigidity were fatal. The patient died on 20th November 2018. The reported cause of death was cardiopulmonary arrest, cyanosis and rigidity. The reporter considered the cardiopulmonary arrest, cyanosis and rigidity to be unrelated to BEXSERO. Additional details were provided as follows: This case was found to be a duplicate of the regulatory case IT-MINISAL02-512448 and all the future corresponding information would be submitted to IT2018GSK214015 (case of record). The Authority reference number for the duplicate case IT-MINISAL02-512448. The patient was born in good clinical conditions, born at term (birth weight as 3.2kg), medical history was negative. In August 2018, the patient received according to National Immunization plan, first doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. No adverse events were reported following these vaccinations. On 20th September 2018, the patient received the first dose of the BEXSERO. On 15th October, 2018, the patient received second doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. Also, after these vaccinations no adverse event were reported. The patient received BEXSERO (not known the precise administration''s hour). The patient came home with his parents and was fine. During the night between 19th and 20th November 2018, the patient''s mother went to his room and realized that the patient was cyanotic and that he was already dead. At night that the parents found the baby in bed cyanotic without breathing. The doctors from emergency diagnosed cardiorespiratory arrest with presence of rigor. CPR until arrival in hospital. The patient''s mother tried to do a cardiac massage, without success, the patient was then taken to the hospital, but he had already passed away. The reporter would inform GlaxoSmithKline of any further detail as soon as they become aware. On 27th November 2018, during follow up from press review the patient demographic details were updated. The press reports that, according to experts who were investigating on the case, the patient''s death was due, at the moment, to the infant''s sudden death syndrome. The expert reports no correlation between the suspect product and the death. Reported Cause(s) of Death: Cardiorespiratory arrest; Cyanosis; Rigidity.
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