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Life Threatening? No
Write-up: Pat. Deceased; This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 96-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 squamous cell carcinoma of skin, hypertonus, type ii diabetes mellitus, copd, dementia and renal insufficiency. Concomitant products included dipyrone (Novaminsulfon), pantoprazole, ramipril, acetylsalicylic acid (ASS), torasemide (Torasemid) and metoprolol. On 15th October 2019, the patient received Influsplit Tetra 2019/2020 (unknown). On 25th October 2019, 10 days after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 25th October 2019. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be unlikely related to Influsplit Tetra 2019/2020. Additional details: The age at vaccination was not reported. However, patient could be 95 or 96 years at the time of vaccination. Other Assessment: Agency. Inconsistent causal association for the event unknown cause of death. Initial information was received from a Physician via regulatory authority on 4th November 2019: Unknown cause of death. Sender comment: 1. In no case, on my part, is the concrete suspicion of a connection between death and the flu vaccine. There were no symptoms of allergic reaction or feverish infections. 2. Experience has shown that 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 82 patients in total) within 2 weeks after vaccination is exceptionally high. The death of the patients was not expected in 4 of the 5 described cases. 4. Concerning prescribed medicines, the only common feature is the novamine sulfone used as a pain-relieving need.; Reported Cause(s) of Death: Unknown cause of death
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