Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Urinary urgency; Lack of efficacy; This Spontaneous report was received from Consumer or other non-health professional and referred to a/an patient of unknown age and gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On an unknown date, patient started therapy with BCG POWDER FOR INTRAVESICAL SUSPENSION (strength, dose, frequency, lot# and expiration date were not provided) via Intravesical for the treatment of Bladder cancer, On an unknown date, the patient experienced Lack of efficacy (Drug ineffective) and Urinary urgency (Micturition urgency). The outcome for the events was not provided. The action taken with BCG POWDER FOR INTRAVESICAL SUSPENSION was Unknown. Causal relationship for the event Drug ineffective was considered to be related to BCG POWDER FOR INTRAVESICAL SUSPENSION and the causality between the event Micturition urgency and BCG POWDER FOR INTRAVESICAL SUSPENSION was not reported. Lot # is being requested and will be submitted if received.
Bladder cancer