Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
night sweats; abdominal pain; diarrhea; He was mixing and preparing TICE BCG and the vial sprayed into his face; he may have overfilled or added too much DILUENT; the vial sprayed into his face; TICE BCG did get on his lip and in his mouth.; Information has been received from Business Partner/CRO on 06-Jun-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender. 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), (indication, expiration date, and lot # were not reported). On an unknown date, the patient experienced he may have overfilled or added too much DILUENT. On an unknown date, the patient experienced the vial sprayed into his face. On an unknown date, the patient experienced TICE BCG did get on his lip and in his mouth.. On an unknown date, the patient experienced abdominal pain. On an unknown date, the patient experienced diarrhea. On an unknown date, the patient experienced night sweats. At the reporting time, the outcome of he may have overfilled or added too much DILUENT, the vial sprayed into his face, TICE BCG did get on his lip and in his mouth., abdominal pain, diarrhea and night sweats was unknown. The action taken with BCG was reported as unknown. The causal relationship between the event of the vial sprayed into his face and BCG was unknown/not reported/not provided. The causal relationship between the event of TICE BCG did get on his lip and in his mouth. and BCG was unknown/not reported/not provided. The causal relationship between the event of diarrhea and BCG was unknown/not reported/not provided. The causal relationship between the event of night sweats and BCG was unknown/not reported/not provided. The causal relationship between the event of abdominal pain and BCG was unknown/not reported/not provided. Lot # is being requested and will be submitted if received This is an invalid report due to lack of patient's identifier. Follow up information has been received from Other health professional on 30-JUL-2025. Patient demographics were updated. It was reported that a male physician was involved in the adverse events. On 27-MAY-2025, When preparing TICE BCG the physician "may have overfilled or added too much DILUENT (if his staff member did not measure correctly) and caused it to build up pressure and spray, but he's really not sure and cannot confirm" (Product preparation issue, Accidental exposure to product). Afterwards the male physician reported he was wearing glasses when the event occurred, but no a mask, so the TICE BCG did not get into his eyes, but a little TICE BCG did get on his lip and in his mouth [the vial sprayed into his face] (Exposure via skin contact, Exposure via mucosa). He removed his jacket and "washed up" his face immediately, but he was not able to shower until several hours later. On 05-JUN-2025, he stated he began experiencing intestinal symptoms such as abdominal pain, diarrhea and night sweats. Outcome for the events was unknown. Action taken and causality assessment with TICE BCG regarding the aforementioned events was unknown. This is one of several reports received from the same reporter. Batch/Lot number is being requested and will be submitted if received.