Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
Last digit of batch number recorded as a 5 and an S; Last digit of batch number recorded as a 5 and an S; Case reference number US-BN-2025-001379 is a spontaneous case initially received from nurse via Bavarian Nordic (reference number: USBAV25-1875) on 31-Jul-2025 and concerns a patient (MULTI X) of unknown age and gender. The patients medical history and concomitant medication details were not provided. On an unspecified date, the patients received the dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for unknown. On the same day, some of the administrators logged the RabAvert with the last digit of the lot as a 5 and some with an S (explicitly coded as: 'Product lot number issue' and 'Product administration error'). *As reported, the investigation has been completed by the packaging department. As the packaging department did not receive any batch numbers related to the issue, they were not able to investigate this specific complaint in detail. However, this type of issue has arisen in previous cases, and corrective actions have already been implemented to address the root cause and to prevent recurrence in future batches.* At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. Bavarian Nordic product quality complaint number for this case is QE-017633. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Additional information received from Bavarian Nordic on 13-Aug-2025 included: investigation summary results.; Reporter's Comments: A spontaneous report concerning a patient of unknown age and gender; received RabAvert with reconstitution components at unknown dose, route, and site; on the same day, lot numbers were inconsistently recorded (last digit "5" vs "S"), coded as product lot number issue and product administration error. The events are considered listed as per company convention. The medical history, concomitant medications, and batch numbers were not provided. Investigation by the packaging department could not address the specific complaint due to missing batch numbers, though similar past issues had corrective actions implemented. No adverse events were reported. Product lot number issue and product administration error are assessed as not related to suspect vaccine, but to human factor. The case is non-serious.; Sender's Comments: A spontaneous report concerning a patient of unknown age and gender; received RabAvert with reconstitution components at unknown dose, route, and site; on the same day, lot numbers were inconsistently recorded (last digit "5" vs "S"), coded as product lot number issue and product administration error. The events are considered listed as per company convention. The medical history, concomitant medications, and batch numbers were not provided. Investigation by the packaging department could not address the specific complaint due to missing batch numbers, though similar past issues had corrective actions implemented. No adverse events were reported. Product lot number issue and product administration error are assessed as not related to suspect vaccine, but to human factor. The case is non-serious.
Comments: None.