Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
Safety missing on needles from Rabavert kit, nurses get stuck with the needle; Safety missing on needles from Rabavert kit; Safety missing on needles from Rabavert kit, nurses get stuck with the needle; Patients received RabAvert vaccine which had safety missing on needles from Rabavert kit; Case reference number US-BN-2025-001061 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: USBAV25-1382) on 12-Jun-2025 and concerns a patients of unknown gender and age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, unspecified number of patients received an unknown dose number of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, via unknown route at unknown site of administration for unknown indication. As reported, there were some issues with the RabAvert kit, nurses got stuck with the needle, because there was no safety on it (explicitly coded as: 'accidental needle stick', 'device safety feature issue', 'product packaging issue' and 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to RabAvert. No further information was provided.; Reporter's Comments: This case report concerns an unspecified number of patients who received an unknown dose number of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, via unknown route at unknown site of administration for unknown indication. Reportedly, there were some issues with the RabAvert kit, nurses got stuck with the needle, because there was no safety on it which is considered as accidental needle stick, device safety feature issue, product packaging issue and product administration error. Injury associated with device, device safety feature issue, product packaging issue and product administration error are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to RabAvert. Injury associated with device, device safety feature issue, product packaging issue and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns an unspecified number of patients who received an unknown dose number of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, via unknown route at unknown site of administration for unknown indication. Reportedly, there were some issues with the RabAvert kit, nurses got stuck with the needle, because there was no safety on it which is considered as accidental needle stick, device safety feature issue, product packaging issue and product administration error. Injury associated with device, device safety feature issue, product packaging issue and product administration error are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to RabAvert. Injury associated with device, device safety feature issue, product packaging issue and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.