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: more Fatigue; appetite was decreasing; most consistent with a toxic metabolic encephalopathy, possibly related to vaccination; low in potassium; was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; was admitted with hypokalernia and hypercalcemla likely secondary to poor p.o. intake in the setting of general malaise after his vaccine; Episodes of diarrhea/at least 1 episode of loose stool; more agitated than usual; Weakness/ was too weak/could not stand up from chair/increased lethargy and weakness; condition aggravated; Cerebral amyloid angiopathy; increased lethargy; experiencing dehydration; CT scan of pelvic area showed left ureter was swollen; Some degree of encephalopathy; low magnesium level; speech was not normal, as he was having some difficulty clearly articulating his words; first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl; Chloride (100,109,108 meq/l); BUN (26,16,14,15 mg/dl); urinalysis resulted high in white blood cell; had difficulty walking to and from the bathroom; tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/Getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it; seemed to momentarily lose his balance a couple of times; unable to hold his urine in until he got on the toilet at time; sleeping a lot/sleeping throughout much of the day; Drowsy throughout the day/Unfortunately developed some dysphagia during his recent episode of somnolence; Unfortunately developed some dysphagia during his recent episode of somnolence; oral exam suggestive of possibly mildly dry mucosa; eGFR was low at 53; was a bit high at 1.25; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; urine was cloudy, and high in WBC, RBC, mucus, leukocytes and protein; UA showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs; Initial information received on 29-Jul-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non-healthcare professional).   This case involves a 94-year-old male patient who died as he was too weak/had weakness/could not stand up from a chair, had increased lethargy and weakness, had a decreasing appetite, had episodes of diarrhea, had more fatigue, was more agitated than usual, was low in potassium, was most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, had cerebral amyloid angiopathy, was unable to hold his urine in until he got on the toilet at times, and was admitted with hypokalemia and hypercalcemia likely secondary to poor PO intake in the setting of general malaise after his vaccine, increased lethargy, ct scan of pelvic area showed left ureter was swollen, some degree of encephalopathy, ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs, at least 1 episode of loose stool, low magnesium level, first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl, sleeping a lot/sleeping throughout much of the day, drowsy throughout the day, seemed to momentarily lose his balance a couple of times, had difficulty walking to and from the bathroom, tried to stand up from his recliner chair, he wasn't quite able to stand up all the way/getting him out of the wheelchair was even harder, as he had too much difficulty standing up from it, urinalysis resulted high in white blood cell, speech was not normal, as he was having some difficulty clearly articulating his words, unfortunately developed some dysphagia during his recent episode of somnolence, experiencing dehydration, oral exam suggestive of possibly mildly dry mucosa, egfr was low at 53, was a bit high at 1.25, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein, chloride (100,109,108 meq/l), bun (26,16,14,15 mg/dl) and unfortunately developed some dysphagia during his recent episode of somnolence after receiving COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech [Comirnaty 2024-2025 formula] and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history included Prostate cancer in 1999 (resolved with surgery), Appendicectomy, Colectomy, Hernia repair, Basal cell carcinoma from 27-Mar-2024 to 22-May-2024 with recovered very well from his MOHS surgery, Cataract operation on 24-Apr-2018, Fall on 19-Oct-2023, Wrist fracture and Helicobacter infection.  The patient's family history included Bladder cancer with Bladder Surgery.  The patient's past medical treatment(s), vaccination(s) was not provided.  At the time of the event, the patient had ongoing Diabetes mellitus, Thyroid disorder, Hyperlipidaemia, Hypertension, Seasonal allergy, Deafness, Dementia Alzheimer's type in 2020 with approximately aug/sep 2020, Vascular dementia in 2020, Pemphigoid and Dementia.  Concomitant medications included Amlodipine besilate (Norvasc) for Hypertension; Acetylsalicylic acid (Aspirin) for Sensation of blood flow; Atorvastatin calcium (Lipitor); Glucose (Glutose); Glucose (Dextrose); Enoxaparin sodium (Lovenox); Propylene glycol (Eucerin original healing); Glucagon; Glucose; Insulin lispro (Admelog); (Humalog); Levothyroxine sodium (Synthroid); Mirtazapine (Remeron); Thiamine hydrochloride (Vitamin B1); Ergocalciferol, Retinol (Vitamin a & d); Macrogol (Polyethylene glycol); Sennoside a+b (Senokot); Levothyroxine sodium (Synthroid); Sennosides nos (Geri kot) for Constipation prophylaxis; Macrogol 3350 (Clearlax) for Constipation prophylaxis; Dupilumab (Dupixent) for Pemphigoid; Terbinafine hydrochloride (Terbinafine) for Onychomycosis; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) for Skin disorder; Ketoconazole (Nizoral) for Psoriasis; Clobetasol propionate for Psoriasis; Ketoconazole (Nizoral) for Dermatitis; Miconazole nitrate (Micotin) for Fungal skin infection; Menthol ; Simvastatin for Blood cholesterol; Linagliptin (Tradjenta) for Type 2 diabetes mellitus; Ibuprofen (Equate); Levothyroxine sodium; Senna alexandrina (Senna); Terbinafine hydrochloride (Lamisil); Calcium citrate, Colecalciferol (Calcium citrate with vitamin D3); Colecalciferol (Vitamin d3); Minerals nos, Vitamins nos (Multivitamin and mineral supplement); Heparin sodium (Heparin); Lisinopril dihydrate (Prinivil); Lisinopril (Zestril); Magnesium hydroxide (Milk of magnesia); Menthol, Zinc oxide (Risamine); Menthol, Zinc oxide (Calmoseptine); Ondansetron hydrochloride (Zofran); Macrogol 3350 (Miralax); Vitamins nos (Theragran); Lactobacillus rhamnosus ; Amoxicillin ; Levofloxacin ; and Omeprazole.  On 06-Oct-2024 at 15:15 hours, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8515DA) and unknown dose of suspect COVID-19 vaccine mRNA omicron (KP.2) Pfizer/Biontech not produced by Sanofi Pasteur (lot LM2210, unknown formulation) via intramuscular route in the arm nos for prophylactic vaccination (Immunisation).    On 06-Oct-2024, the patient developed more agitated than usual (agitation), unable to hold his urine in until he got on the toilet at time (urinary incontinence)  (latency same day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.   On 07-Oct-2024, the patient developed episodes of diarrhea (diarrhoea) (latency 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.   On 08-Oct-2024, the patient developed seemed to momentarily lose his balance a couple of times (balance disorder) (latency 1 day 8 hrs 45 min)  following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.  On 10-Oct-2024, the patient developed low in potassium (blood potassium decreased), was admitted with hypokalemia and hypercalcemia likely secondary to poor p.o. intake in the setting of general malaise after his vaccine (hypokalaemia), (hypercalcaemia) , first reading was 91, short time later it was a bit higher it was 101/checked his blood sugar, glucose of 178,189,200,259 mg/dl (blood glucose increased), drowsy throughout the day (somnolence), urinalysis resulted high in white blood cell (white blood cells urine positive), chloride (100,109,108 meq/l) (blood chloride increased), bun (26,16,14,15 mg/dl) (blood urea abnormal)  (latency 3 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.   On 12-Oct-2024, the patient developed most consistent with a toxic metabolic encephalopathy, possibly related to vaccination (metabolic encephalopathy), speech was not normal, as he was having some difficulty clearly articulating his words (speech disorder), low magnesium level (blood magnesium decreased) (latency 5 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.    On 13-Oct-2024, the patient developed unfortunately developed some dysphagia during his recent episode of somnolence (somnolence) (latency 6 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.  On 15-Oct-2024, the patient developed some degree of encephalopathy (encephalopathy) (latency 8 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.   On 17-Oct-2024, the patient developed appetite was decreasing (decreased appetite) (latency 10 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.    On 26-Oct-2024, the patient developed increased lethargy (lethargy), ct scan of pelvic area showed left ureter was swollen (hydroureter),dehydration (dehydration) (latency 19 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.  On an unknown date in Oct-2024, the patient developed weakness/ was too weak/could not stand up from chair/increased lethargy and weakness (asthenia), cerebral amyloid angiopathy, at least 1 episode of loose stool (diarrhoea), sleeping a lot/sleeping throughout much of the day (hypersomnia), unfortunately developed some dysphagia during his recent episode of somnolence (dysphagia), condition aggravated  (latency approximately few days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.   On 04-Nov-2024, the patient developed more fatigue (fatigue) (latency 28 days 8 hrs 45 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine and Comirnaty 2024-2025 formula.   On an unknown date in 2024, the patient developed ua showed pyuria with wbc of 51 to 100, wbc clumps, some rbcs (pyuria), oral exam suggestive of possibly mildly dry mucosa (mucosal dryness) , egfr was low at 53 (glomerular filtration rate decreased), was a bit high at 1.25 (blood creatinine increased), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (urine abnormality), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (red blood cells urine positive), urine was cloudy, and high in wbc, rbc, mucus, leukocytes and protein (protein urine present)  (latency approximately few months) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine And Comirnaty 2024-2025 formula.  Relevant laboratory test results included: Anion gap - On 10-Oct-2024: 5 meq/L; on 11-Oct-2024: 3 meq/L; on 13-Oct-2024: 6 meq/L; on 14-Oct-2024: 11 meq/L; on 15-Oct-2024: 7 meq/L Blood calcium - On 10-Oct-2024: 12.5 mg/dL; on 11-Oct-2024: 10.9 mg/dL; on 13-Oct-2024: 9.7 mg/dL; on 14-Oct-2024: 8.8 mg/dL; on 15-Oct-2024: 9.1 mg/dL Blood chloride - On 10-Oct-2024: 100 meq/L; on 11-Oct-2024: 107 meq/L; on 13-Oct-2024: 109 meq/L; on 14-Oct-2024: 108 meq/L; on 15-Oct-2024: 108 meq/L; on 04-Nov-2024: 107 UNK Blood creatinine - On 10-Oct-2024: 1.20 mg/dL; on 11-Oct-2024: 1.09 mg/dL; on 13-Oct-2024: 1.03 mg/dL; on 14-Oct-2024: 0.95 mg/dL; on 15-Oct-2024: 0.90 mg/dL; on 26-Oct-2024: 1.23 UNK; on 28-Oct-2024: 1.23 UNK; on 04-Nov-2024: 0.94 UNK; in 2024: 1.25 UNK Blood glucose - On 10-Oct-2024: 178 mg/dL; on 11-Oct-2024: 202 mg/dL then 212 mg/dL; on 13-Oct-2024: 189 mg/dL; on 14-Oct-2024: 224 mg/dL; on 15-Oct-2024: 259 mg/dL; on 04-Nov-2024: 133 UNK Blood magnesium - On 11-Oct-2024: 1.8 UNK; on 12-Oct-2024: 1.7 UNK Blood potassium - On 10-Oct-2024: 2.8 meq/L; on 11-Oct-2024: 3.0 meq/L; on 13-Oct-2024: 3.0 meq/L; on 14-Oct-2024: 3.0 meq/L; on 15-Oct-2024: 2.7 meq/L; on 04-Nov-2024: 3.9 UNK Blood urea - On 10-Oct-2024: 26 mg/dL; on 11-Oct-2024: 18 mg/dL; on 13-Oct-2024: 16 mg/dL; on 14-Oct-2024: 14 mg/dL; on 15-Oct-2024: 15 mg/dL; on 26-Oct-2024: 37 UNK; on 28-Oct-2024: 37 UNK Computerised tomogram - On 26-Oct-2024:  [left ureter was swollen] Glomerular filtration rate - On 10-Oct-2024: 56 mL/min; on 11-Oct-2024:  [>60 mL/min]; on 13-Oct-2024:  [>60 mL/min]; on 14-Oct-2024:  [>60 mL/min]; on 15-Oct-2024:  [>60 mL/min]; in 2024: 53 UNK Magnetic resonance imaging - On 12-Oct-2024:  [Metabolic encephalopathy, severe microvascular disease and amyloiddeposit] Urine analysis - On 10-Oct-2024:  [showed pyuria with WBC of 51 to 100, WBC clumps, some RBCs]  Final diagnosis was (fatal) most consistent with a toxic metabolic encephalopathy, possibly related to vaccination, (fatal) cerebral amyloid angiopathy.  Action taken was not applicable.  The patient was treated with Quetiapine fumarate (Seroquel) and Lorazepam (Ativan).  At time of reporting, the outcome was Unknown for the event (Asthenia, Urine analysis abnormal, Blood chloride increased, Urine abnormality ,pyuria ,Somnolence, dysphagia diarrhea, Mucosal dryness, Glomerular filtration rate decreased, dehydration, Blood creatinine increased, Diarrhoea, Balance disorder, low magnesium level), was Unknown for the event (Red blood cells urine positive), Somnolence), (Blood glucose increased), fatigue, was Fatal for the event (cerebral amyloid angiopathy),  was Recovering / Resolving for the event (Speech disorder, hypokalemia) , hypercalcemla (Blood urea abnormal), Decreased appetite), Gait disturbance, (Decreased appetite), was Recovered / Resolved on 15-Oct-2024 for the event (encephalopathy),  was Recovered / Resolved With Sequelae on an unknown date in 2025 for the event (Agitation), was Recovered / Resolved on 08-Nov-2024 for the event (dysphagia ) , was Recovered / Resolved on an unknown date in 2024 for the event (low in potassium) and was Not Recovered / Not Resolved for the event (lethargy),  No autopsy was done. The cause of death was reported as Cerebral amyloid angiopathy and Metabolic encephalopathy.  Seriousness criteria- The patient was hospitalized for the event (urinary incontinence, hypercalcaemia). The event was leading to disability. The patient was hospitalized for the event (Agitation). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Encephalopathy). The event was assessed as medically significant and was leading to death. The patient was hospitalized for this event (Metabolic encephalopathy).  This event was assessed as medically significant. The patient was hospitalized for this event (hypokalaemia). The patient was hospitalized for this event (hypercalcaemia). The patient was was assessed as medically significant. (Hydrouter, Encephalopathy).; Sender's Comments: Company comment dated on 01-Aug-2025: This is an initial report of serious unlisted events with fatal outcome. A 94-year-old male with significant PMH for Alzheimer's disease, vascular dementia, diabetes mellitus, bladder cancer, and multiple other conditions, and treatment with multiple medications (including insulin, antihypertensives, and thyroid medications) developed metabolic encephalopathy, weakness, and electrolyte imbalances with TTO 4 days after receiving Fluzone High Dose co-administered with Comirnaty. Patient was hospitalized 4 days post-vaccination and died on 25-Nov-2024 (50 days after vaccination). No information regarding autopsy, death certificate, or specific cause of death was provided. PMH and extensive medication history (50+ medications) serve as strong confounders. The role of the suspect vaccine is possible based on temporality but unlikely due to confounding by concomitant vaccination, patient's advanced age, multiple comorbidities, and polypharmacy (50+ concomitant medications). More complete information is needed regarding event, autopsy and exclusions of alternate etiologies. Given the patient's complex medical condition and multiple confounders, further medical assessment was not possible.; Reported Cause(s) of Death: Cerebral amyloid angiopathy; Metabolic encephalopathy