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Life Threatening? No
Write-up: patient died; This case was reported by a physician via other manufacturer and described the occurrence of unknown cause of death in a 88-year-old patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) for prophylaxis. Concurrent medical conditions included hypertonus, coronary heart disease, osteoporosis, dementia, arthrosis multiple and pain. Concomitant products included thyroxine sodium (Thyroxine), acetylsalicylic acid (ASS), ergocalciferol (Vigantoletten), buprenorphine (Norspan), pipamperone hydrochloride (Pipamperon), ambiguous medication nos (Tavor (Nos)) and bisoprolol. On 16th October 2019, the patient received Influsplit Tetra 2019/2020. On 19th October 2019, 3 days after receiving Influsplit Tetra 2019/2020, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). The patient was treated with dipyrone (Novaminsulfon). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 19th October 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influsplit Tetra 2019/2020. Additional details were provided as follows: The age at vaccination was not reported but it could be 87 years or 88 years. The patient also received Alendronsr as concomitant medication. The reporter stated, there was an increased occurrence of death cases in an old people''s home with timely relatedness with a Tetravalent Influenza Vaccination With Influsplit tetra. The patient was vaccinated with the tetravalent vaccine Infulsplit, batch number was provided via telephone on the 25th October 2019 (but was not mentioned in the source document). As per reporter, there was no causality suspected and this cases had no causal relatedness between the vaccination and the death of the patient. Neither Symptoms like allergic reactions nor symptoms like febrile infections occurred. The reporter asked about information regarding similar reports from other medical practices. The reporter provided more information about the incident. In the timeframe of 4th October 2019 to 25th October 2019, total 5 patients were died in an old people''s home of 74 vaccinated patients. The vaccinations took place from 15th October 2019 to 17th October 2019. The reporter further added, as per their experience, outstandingly more patients of a retirement home died in the 4. Quartal as in the other Quartals. In the 4. Quartal of 2018, 8 out of 92 patients were died in the retirement home where the reporter was taking care. The amount of 5 patients who died out of totally 82 patients from the retirement home during 2 weeks after the vaccination was although exceptional. The death was not predictable at 4 out of the deceased patients. This is 1 of 5 cases reported by the same reporter.; Reported Cause(s) of Death: Death NOS
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