Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUN3 | INFLUENZA (SEASONAL) (FLUENZ) | MEDIMMUNE VACCINES, INC. | UNK | — | — |
Patient is deceased; A solicited report has been received from a other health professional in Patient Support Program. The report concerns a male elderly patient born in 1936 (age 88 years). No medical history was reported. No concomitant products were reported. The patient started treatment with Dapagliflozin (dapagliflozin) (batch number(s) Unknown), on an unknown date for product used for unknown indication. It is unknown if any action was taken with Covid-19 Vaccine (covid-19 vaccine) and Fluenz (influenza vaccine live reassort 3v). The patient died (preferred term: Death) on 22-FEB-2025. The patient died on 22-FEB-2025. It is not known whether an autopsy was performed. The cause of death was unknown. The event was considered serious (Medically Significant and Death). The reporter did not assess causality for patient is deceased.The reporter did not consider that there was a reasonable possibility of a causal relationship between Dapagliflozin and the following event(s): patient is deceased. The company physician did not consider that there was a reasonable possibility of a causal relationship between Dapagliflozin and the following event(s): patient is deceased. The company physician considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): patient is deceased. The company physician considered that there was a reasonable possibility of a causal relationship between Fluenz and the following event(s): patient is deceased. Significant correction on 30-Apr-2025 : coding for the suspect drug influenza has been updated narrative amended,; Sender's Comments: This is a case report of an 88-year-old male patient with reported fatal outcome (Preferred term: Death) in association with covid 19. Cause of death was further not specified. Advanced age could be possibly confounding. Due to limited information on cause of death, circumstances leading to fatal outcome, indication, autopsy details, medical history, concurrent diseases, concomitant medications, etiological and diagnostic workup, other risk factors; the evaluation did not find evidence to exclude a causal relationship between fatal outcome and suspect; Reported Cause(s) of Death: unknown cause of death
Medical History/Concurrent Conditions: Product used for unknown indication
DAPAGLIFLOZIN