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Life Threatening? No
Write-up: pulmonary edema; Deceased below the clinical picture of decompensated heart failure with pulmonary edema; This case was reported by a physician via regulatory authority and described the occurrence of lung oedema in a 92-year-old patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA389CA, expiry date unknown) for prophylaxis. The patient''s past medical history included atrial fibrillation, paraparesis (the legs), type ii diabetes mellitus, arthritis rheumatoid, hypertonus, dementia and cerebral atherosclerosis. Concomitant products included dipyrone (Novaminsulfon), ramipril, frusemide, acetylsalicylic acid (ASS) and bisoprolol. On 16th October 2019, the patient received Influsplit Tetra 2019/2020 (unknown). On 26th October 2019, 10 days after receiving Influsplit Tetra 2019/2020, the patient experienced lung oedema (serious criteria death and GSK medically significant) and decompensated heart failure (serious criteria death and GSK medically significant). On an unknown date, the outcome of the lung oedema and decompensated heart failure were fatal. The patient died on 26th October 2019. The reported cause of death was decompensated heart failure and lung oedema. It was unknown if the reporter considered the lung oedema and decompensated heart failure to be related to Influsplit Tetra 2019/2020. Additional details: The age at vaccination was not reported. However, patient could be 91 or 92 years at the time of vaccination. Initial information was received from a Physician via regulatory authority on 4th November 2019: Deceased below the clinical picture of decompensated heart failure with pulmonary edema, Sender comment: 1.In no case on my part there is the concrete suspicion of a connection between death and the flu vaccine. There were no symptoms of allergic reaction or feverish infections. 2. According to experience, significantly more nursing home patients die off in the fourth quarter than in the other quarters. In the fourth quarter of 2018, 8 out of the 92 patients under my care died. 3. However, the number of 5 deceased patients (out of a total of 82 home patients) within 2 weeks of vaccination is exceptionally high. The death of the patients was in 4 of the 5 expected cases not expected. 4. Regarding the prescribed medicines, the only thing that is common is the Novaminsulfone, which is used as a pain-remedy.; Reported Cause(s) of Death: Decompensated heart failure; Lung oedema
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