Received Oct 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Bladder irritation from BCG; This spontaneous report was received from a Consumer or other non-health professional via other pharmaceutical company and refers to a 73-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with BCG (TICE BCG LIVE) (exact dose, frequency, indication, lot # and expiration date were not reported). On an unknown date, the patient experienced Bladder irritation. At the reporting time, the outcome of Bladder irritation was unknown. The action taken with BCG was not reported. The reporter considered the event of Bladder irritation to be related to BCG. Batch/Lot number is being requested and will be submitted if received