Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | UNK | Z008265 | — |
A medical assistant reported that one VAXNEUVANCE syringe was found to be broken in the tray. She will send photos and return the tray which has the one broken syringe. AE was also filed because one of the other medical assistants "poked" her finge; other medical assistants "poked" her finger on the broken glass; injury associated with device; Information has been received from Business Partner on 27-Aug-2025, 03-Sep-2025, and 09-Sep-2025. This spontaneous report was received from a Other health professional and refers to a female patient of unknown age. 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 Pneumococcal 15-valent Conjugate Vaccine (lot #Z008265, expiration date: 21-Jul-2027) for an unknown indication. On an unknown date, a medical assistant reported that one VAXNEUVANCE syringe was found to be broken in the tray. She will send photos and return the tray which has the one broken syringe. AE was also filed because one of the other medical assistants "poked" her finger on the broken glass (injury associated with device and syringe broken). The patient recovered/resolved from the event of other medical assistants "poked" her finger on the broken glass on an unspecified date. The action taken with Pneumococcal 15-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of other medical assistants "poked" her finger on the broken glass and Pneumococcal 15-valent Conjugate Vaccine was unknown/not reported/not provided.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-08-28 , number : , number : , number : , number : 02863296 , Central date : 2025-08-27 , Classification : , Attachment description : Post Marketing Basic , Safety case number :