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Life Threatening? No
Write-up: This case was reported by a physician via regulatory authority and described the occurrence of dependent edema in a 88-year-old male patient who received Flu Seasonal QIV Dresden (FLUARIX TETRA 2018-2019 season) (batch number AFLBA326BB, expiry date unknown) for prophylaxis. Concurrent medical conditions included cardiac valve disease, renal failure, hepatitis C, atrial fibrillation, cough weak and emphysema pulmonary. Concomitant products included TRIATEC, SERETIDE, AMIODAR, DIBASE, NORMIX, ELIQUIS and LASIX. On 19th November 2018, the patient received FLUARIX TETRA 2018-2019 season (intramuscular) .5 ml. On 19th November 2018, less than an hour after receiving FLUARIX TETRA 2018-2019 season, the patient experienced dependent edema (serious criteria death), diminished lung sounds (serious criteria death), phlegm (serious criteria death) and cough (serious criteria death). On 19th November 2018, the outcome of the dependent edema, diminished lung sounds, phlegm and cough were fatal. The patient died on 19th November 2018. The reported cause of death was phlegm, dependent oedema, diminished lung sounds and cough. It was unknown if the reporter considered the dependent edema, diminished lung sounds, phlegm and cough to be related to FLUARIX TETRA 2018-2019 season. Additional details: The formulation for SERETIDE was reported as pressurized suspension. Initial information was reported by a physician via regulatory authority on 28th November 2018: From a few days a light cough with light, no fever eupnoic mucus, no peripheral edema, no pathological noises at the base of the lung, reduced respiratory physiological noises.. good blood pressure and heartbeat. Death one hour after vaccination. Reporter''s comment: I administered FLUARIX because I had finished FLUADS. I visited the patient before administering the vaccine and the patient was in compensation as I specified in a previous box. The vaccine was administered at home, where I remained over half an hour because I visited his wife also. When I left the patient was perfectly fine. Reported Cause(s) of Death: Phlegm; Dependent oedema; Diminished lung sounds; Cough.
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