Received Feb 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IN / NS |
PATIENT IS BLIND; Renal osteodystrophy; Hypertensive chronic kidney disease; Chronic depression; Dyslipidemia; Peripheral vascular disease (HCC); Diabetic peripheral neuropathy (HCC); A solicited report has been received from a physician in Patient Support Program. The report concerns a female adult patient (age 63 years, height 165.1 cm, weight 83.9 kg). The patient's past and current medical history included acute injury of kidney (dates not reported), anemia (dates not reported), cellulitis of right foot (dates not reported), fluid overload (dates not reported), gastroenteritis (dates not reported), history of sars-cov-2 (dates not reported), hypocalcemia (dates not reported), irritable bowel syndrome (dates not reported), paraplegia (ongoing), pneumonia (dates not reported) and retinopathy (dates not reported). Concomitant medication included Aspirin, Atorvastatin, Lantus Solostar and Carvedilol. The patient started treatment with Farxiga (dapagliflozin) UNK, on an unknown date and with Lokelma (sodium zirconium cyclosilicate) UNK, on an unknown date. On an unknown date, the patient experienced patient is blind (preferred term: Blindness), renal osteodystrophy (preferred term: Chronic kidney disease-mineral and bone disorder), diabetic peripheral neuropathy (hcc) (preferred term: Diabetic neuropathy), peripheral vascular disease (hcc) (preferred term: Peripheral vascular disorder), dyslipidemia (preferred term: Dyslipidaemia), chronic depression (preferred term: Depression) and hypertensive chronic kidney disease (preferred term: Hypertensive nephropathy). It is unknown if any action was taken with Farxiga (dapagliflozin), Influenza Vaccine (flumist, influenza virus vaccine polyvalent, q/laiv) and Lokelma (sodium zirconium cyclosilicate). The outcome of the event(s) of chronic depression, diabetic peripheral neuropathy (hcc), dyslipidemia, hypertensive chronic kidney disease, patient is blind, peripheral vascular disease (hcc) and renal osteodystrophy was unknown. The following event(s) were considered serious due to medically significant:patient is blind, renal osteodystrophy and hypertensive chronic kidney disease. The following events were considered non-serious:chronic depression, diabetic peripheral neuropathy (hcc), dyslipidemia and peripheral vascular disease (hcc). The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): chronic depression, diabetic peripheral neuropathy (hcc), dyslipidemia, hypertensive chronic kidney disease, patient is blind, peripheral vascular disease (hcc) and renal osteodystrophy. The company physician considered that there was a reasonable possibility of a causal relationship between Farxiga and the following event(s): chronic depression, diabetic peripheral neuropathy (hcc), dyslipidemia, hypertensive chronic kidney disease, patient is blind, peripheral vascular disease (hcc) and renal osteodystrophy. The company physician considered that there was a reasonable possibility of a causal relationship between Influenza Vaccine and the following event(s): chronic depression, diabetic peripheral neuropathy (hcc), dyslipidemia, hypertensive chronic kidney disease, patient is blind, peripheral vascular disease (hcc) and renal osteodystrophy. The company physician considered that there was a reasonable possibility of a causal relationship between Lokelma and the following event(s): chronic depression, diabetic peripheral neuropathy (hcc), dyslipidemia, hypertensive chronic kidney disease, patient is blind, peripheral vascular disease (hcc) and renal osteodystrophy. Device Information: Combination Product Report: Yes Product As Reported: Influenza Vaccine Brand Name: INFLUENZA VACCINE Product Role:Suspect Device Problem code:A24 - Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Summary of follow-up information received by AstraZeneca 21-NOV-2025 from Physician via Patient Support Program: Historical Condition added. New suspect drug lokelma and influenza vaccine added. concomitant drug added. New event Renal osteodystrophy, Hypertensive chronic kidney disease, Chronic depression, Dyslipidemia, Peripheral vascular disease (HCC), Diabetic peripheral neuropathy (HCC) was added. Narrative updated. Non significant correction on 02-Dec-2025: PDPR added. Narrative updated. Corrected report on 10-Dec-2025: General tab updated. Narrative updated.; Sender's Comments: Blindness, chronic kidney disease-mineral and bone disorder and hypertensive nephropathy are not listed in the company core data sheet of dapagliflozin, sodium zirconium cyclosilicate and flumist, influenza virus vaccine polyvalent, q/laiv. Underlying hypertension, chronic kidney disease and cataract could be contributing. Due to limited information on circumstances leading to events, indication, start date and action taken of suspect drugs, onset date and outcome of the events, clinical course and treatment provided for the events, more detailed etiological and diagnostic workup, the evaluation did not find the evidence to exclude a causal relationship between the events and suspect drugs.
Paraplegia
Medical History/Concurrent Conditions: Acute kidney injury; Anemia; Cellulitis; Fluid overload; Gastroenteritis; Hypocalcemia; Irritable bowel syndrome; Pneumonia; Retinopathy; SARS-CoV-2 infection; Surgery
Aspirin; Atorvastatin; Carvedilol; Lantus Solostar; DAPAGLIFLOZIN; LOKELMA