Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
Patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number; Patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number; Case reference number US-BN-2024-002839 is a spontaneous case report initially received on 20-Nov-2024 from other health care professional via Bavarian Nordic and concerns a patient of unspecified age and gender. The patient's relevant medical history and concomitant medication details were not reported. On unspecified date, the patient was vaccinated with a dose of RabAvert (batch number: unknown) along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution at unknown dose, route or site of administration, for unknown indication. As reported, the patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number (explicitly coded as 'Product barcode readability issue' and 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. The product quality complaint number was QE-013176. Additional information received from the reporter on 04-Dec-2024: Information included confirmation of country of occurrence and that the patient received affected vaccine.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with a dose of RabAvert along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution at unknown dose, route or site of administration, for unknown indication. Reportedly, the patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number which is considered as product barcode readability issue and product administration error. Product barcode issue and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to RabAvert. Patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender was vaccinated with a dose of RabAvert along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution at unknown dose, route or site of administration, for unknown indication. Reportedly, the patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number which is considered as product barcode readability issue and product administration error. Product barcode issue and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to RabAvert. Patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None