Age: 94.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, FLU3, COVID19, FLU3, COVID19, FLU3
Symptoms: Red blood cells urine positive, Somnolence, Speech disorder, Urinary incontinence, Urine abnormality
Clinical narrative: toxic metabolic encephalopathy; passing away; got weaker; more agitated than usual; started on a "downward spiral"/dementia may have precipitated his decline.; Initial information received on 27-Jun-2025 regarding an unsolicited valid  serious case received from a consumer/non-healthcare porfessional.  This case involves a 94 years old male patient who experienced toxic metabolic encephalopathy, was more agitated than usual, started on a "downward spiral"/dementia may have precipitated his decline. and got weaker and had passed away after receiving covid-19 vaccine and influenza USP trival A-B high dose subvirion vaccine [Fluzone HD].  The patient's past vaccination(s) included fluzone in 2022, fluzone in 2023, covid and covid. 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.  Concomitant medications included omeprazole for Product used for unknown indication.  On 06-Oct-2024, the patient received 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength and expiry date) with lot U8515DA via unknown route in unknown administration site for Immunization and unknown dose of suspect covid-19 vaccine (Unknown strength,, formulation, lot and expiry date) not produced by Sanofi Pasteur via unknown route in unknown administration site for Prophylactic vaccination (Immunisation)  On an unknown date in 2024 the patient developed toxic metabolic encephalopathy (toxic encephalopathy) and downward spiral"/dementia may have precipitated his decline. (general physical health deterioration) (unknown latency) following the administration of influenza USP trival A-B HIGH dose subvirion vaccine and covid-19 vaccine.   On 06-Oct-2024 the patient developed more agitated than usual (agitation) (Latency same day) following the administration of influenza USP trival A-B high dose subvirion vaccine and covid-19 vaccine.  On 07-Oct-2024 the patient developed got weaker (asthenia) (Latency 1 day) following the administration of influenza USP trival A-B high dose subvirion vaccine and covid-19 vaccine.  On 25-Nov-2024 the patient developed passing away (death) (Latency 1 month 19 days) following the administration of influenza USP trival A-B high dose subvirion vaccine and covid-19 vaccine.   Reportedly, The patient was taking two antibiotics, omeprazole, and a probiotic, and was having no problems with any of those products. The patient's doctor suggested that once he completed the course of antibiotics, the patient should receive the flu vaccine and the Covid vaccine. The patient finished the course of antibiotics on 03-Oct-2024 and they waited a few days, and then the patient got the Fluzone High-dose trivalent vaccine and the Covid vaccine on 06-Oct-2024. That same night, the patient was more agitated than usual, and early the next day he got weaker, and he ended up in the emergency room (ER) on the morning of 10-Oct-2024. Soon after getting the Fluzone High Dose and Covid vaccine, the patient began having additional health issues, getting weaker, and started on a downward spiral and ended up passing away on 25-Nov-2024. After getting the two vaccines on 06-Oct-2024, the patient was in and out of the hospital and rehabilitation for a month. The patient returned home on 05-Nov-2024, and he had a few good days, rested, and was awake and alert, but then he took another turn for the worse. The patient did not want to go back to the hospital, and on 13-Nov-2024 he was placed on hospice care. The patient had received the Fluzone High-Dose vaccine and the Covid vaccine the prior two years (2023 and 2022) without experiencing any problems. The nurse practitioner who coordinated the patients care at the hospital the first five days and the neuro-hospitalist said that the vaccines may have contributed to the patient's decline. While in the hospital, the patient was diagnosed with toxic metabolic encephalopathy. The patient was 94 years old and did have advanced dementia, but getting the two vaccines at the same time in light of the patient's advanced age and dementia may have precipitated his decline. The reporter believes that there should be some adjustment in the recommendations for administering the vaccines to patients like her father, to wait until after any course of antibiotics, and to give the vaccines one at a time, not both of them at the same time  Final diagnosis was (fatal) passing away.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  It is unknown if an autopsy was done. The cause of death was reported as Death.  Seriousness criteria: These events (Death and Toxic encephalopathy) was assessed as medically significant and for the event death NOS: death. The patient was hospitalized for the event (Toxic encephalopathy) in  2024; Sender's Comments: Sanofi company comment dated 01-Jul-2025: This is an initial fatal case report. A 94-year-old male with incomplete past medical and medication history (but known to have ongoing dementia, and treatment with omeprazole) developed encephalopathy, agitation, worsening dementia and increasing weakness with fatal outcome 1 month and 19 days after concomitant vaccination with Fluzone TIV-HD vaccine and non-company COVID19 vaccine. Elderly age and pre-existing medical conditions likely explain the events and outcome; and concomitant vaccine, advanced patient's age serves as an additional confounder. However, more complete information is needed regarding event onset, medical history, medication history, medical condition at the time of vaccination, clinical course, laboratory investigations, autopsy report and specific cause of death to exclude alternate etiologies hence, further medical assessment was not possible; Reported Cause(s) of Death: Death NOS