Age: 94.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Fatigue, Hospitalisation, Hypersomnia
Clinical narrative: He was hospitalized; Ended up having to go to rehab the physical therapy; Came home but he never recovered; He was in the hospital for a week; A little more agitated than usual; Appetite was decreasing; Sleeping a lot; He was low in potassium; Episodes of diarrhea; He gradually became so weak between October; Was too weak to stand up from his chair; Fatigue; He got the shots on October 6th and he passed away on November 25th; Initial information received on 23-Jun-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 94 years old male patient (163 cm and 61.46 kg) who had he got the shots on October 6th and he passed away on November 25th, he was hospitalized; ended up having to go to rehab the physical therapy; came home but he never recovered; he was in the hospital for a week, a little more agitated than usual, appetite was decreasing, sleeping a lot, he was low in potassium, episodes of diarrhea, he gradually became so weak between october; was too weak to stand up from his chair and fatigue after receiving COVID-19 vaccine and influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past vaccination(s) included covid-19 vaccine and fluzone high dose on an unknown month in 2022, covid-19 vaccine and fluzone high dose on 26-SEP-2023. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Dementia.   On an unknown date, the patient received an unknown dose of suspect covid-19 vaccine produced by unknown manufacturer (lot LM2210) via unknown route in unknown administration site. On 06-Oct-2024, the patient received an unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine; Suspension for injection in pre-filled syringe (lot U8515DA) via unknown route in a upper arm both (with unknown strength and expiry date) for Prophylactic vaccination (Immunisation).  On 10-OCT-2024, he was hospitalized; ended up having to go to rehab the physical therapy; came home but he never recovered; he was in the hospital for a week (hospitalisation) (latency: 4 days)  On 25-NOV-2024, he got the shots on october 6th and he passed away on november 25th (death) (latency: 1 month 19 days)  On an unknown date the patient developed a little more agitated than usual (agitation), appetite was decreasing (decreased appetite), sleeping a lot (hypersomnia), he was low in potassium (blood potassium decreased) episodes of diarrhea (diarrhoea), he gradually became so weak between october; was too weak to stand up from his chair (asthenia), fatigue (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events- agitation, decreased appetite, hypersomnia, blood potassium decreased, diarrhea, fatigue , hospitalization and asthenia.  At time of reporting, the outcome was Unknown for events - agitation, decreased appetite, hypersomnia, blood potassium decreased, diarrhea, fatigue , hospitalization and asthenia.  It is unknown if an autopsy was done. The cause of death was not reported; Sender's Comments: Sanofi company comment dated 26-Jun-2025: This case involves a 94 years old male patient (163 cm and 61.46 kg) who had he got the shots on October 6th and he passed away on November 25th, he was hospitalized; ended up having to go to rehab the physical therapy; came home but he never recovered; he was in the hospital for a week, a little more agitated than usual, appetite was decreasing, sleeping a lot, he was low in potassium, episodes of diarrhea, he gradually became so weak between october; was too weak to stand up from his chair and fatigue after receiving COVID-19 vaccine and influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose]. Concurrent medical conditions included Dementia. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: passed away