Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | FDP00756 | — |
RabAvert vaccine was dispensed to a patient for self-administration; The patient self administered the RabAvert vaccine first dose; The patient was supposed to get RabAvert second dose on day 7 but its been 11 days the patient did not receive the second dose; The prefilled sterile diluent syringe was empty, and the vaccine pellet could not be reconstituted.; Case reference number US-BN-2025-002021 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-001389) on 30-Dec-2025 and concerns a female patient of an unknown age. The patient's medical history and concomitant medications details were not provided. On 17-Dec-2025, reported as Wednesday, the patient received the first dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution *(batch number: FDP00756, Exp. date: Nov-2028) at a dose of 1 millilitres (ml)*, route, and site of administration for pre-exposure prophylaxis. On an unspecified date, a RabAvert vaccine was dispensed to a patient for self-administration (explicitly coded as 'product dispensing error'). The vaccine package appeared sealed and intact at the time of receipt. However, the prefilled sterile diluent syringe was found to be empty, and the vaccine pellet could not be reconstituted (explicitly coded as 'syringe issue'). The patient attempted to administer the vaccine by injecting the diluent syringe into the vial, as done with the first dose (explicitly coded as 'product administration error'). No solution entered the vial, as the syringe contained no liquid. The needle was correctly attached, but the syringe appeared never to have been filled, suggesting a potential manufacturing or assembly issue. The healthcare professional (HCP) confirmed that only the prefilled syringe was empty and that the vaccine was in the patient's possession. The patient was supposed to get RabAvert second dose on day 7 but it's been 11 days the patient did not receive the second dose (explicitly coded as 'incomplete course of vaccination'). As reported, the patient was advised not to self-administer the injection and to contact her healthcare provider for any questions. *The filling and packaging investigation has been completed. No irregularities were observed in relation to a potential empty syringe as all manufacturing processes were in compliance. Based on the investigation findings, this complaint was deemed not justified. Syringe filling was not performed at PCI, and PCI operations rely on the receipt of approved bulk. PCI was not responsible for the quality of the incoming bulk. An empty syringe originating in the bulk product would not be detected during the packaging operations. The filling and packaging investigation has been completed. No irregularities were observed in relation to a potential empty syringe as all manufacturing processes were in compliance.* The product complaint number was (QE-020143). Additional information received from consumer via Bavarian Nordic on 31-Dec-2025 included: New information included event details, RabAvert dosing details and additional reference number (CASE-001415). Additional information received from consumer via Bavarian Nordic on 31-Dec-2025 included: New information included patient details, pictures of RabAvert product, and patient confirmed that the sterile diluent syringe was empty, therefore, the RabAvert pellet could not be reconstituted. Additional information received from Bavarian Nordic on 31-Dec-2025 included: New information included PQC number (QE-020143). Additional information received from consumer via Bavarian Nordic on 02-Jan-2026 included: New information included the patient was advised not to self-administer the injection and to contact her healthcare provider for any questions and description of the event was added. Additional information received from consumer via Bavarian Nordic on 04-Jan-2026 included: New information included the healthcare provider did not have the product available at the pharmacy, and the patient had the product in her possession. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up received from a pharmacist via on 03-Feb-2026: New information included product dosing details and product complaint details were added.; Reporter's Comments: A female patient of an unknown age received the first dose of RabAvert for pre-exposure prophylaxis. On an unspecified date, a RabAvert vaccine was dispensed to a patient for self-administration, which is considered as product dispensing error. The vaccine package appeared sealed and intact at the time of receipt. However, the prefilled sterile diluent syringe was found to be empty, and the vaccine pellet could not be reconstituted, which is considered as syringe issue. The patient attempted to administer the vaccine by injecting the diluent syringe into the vial, as done with the first dose, which is considered as product administration error. The patient was supposed to get RabAvert second dose on day 7 but it's been 11 days the patient did not receive the second dose, which is considered as incomplete course of vaccination. Product dispensing error, product administration error, incomplete course of vaccination and syringe issue are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Product dispensing error, product administration error, incomplete course of vaccination and syringe issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of an unknown age received the first dose of RabAvert for pre-exposure prophylaxis. On an unspecified date, a RabAvert vaccine was dispensed to a patient for self-administration, which is considered as product dispensing error. The vaccine package appeared sealed and intact at the time of receipt. However, the prefilled sterile diluent syringe was found to be empty, and the vaccine pellet could not be reconstituted, which is considered as syringe issue. The patient attempted to administer the vaccine by injecting the diluent syringe into the vial, as done with the first dose, which is considered as product administration error. The patient was supposed to get RabAvert second dose on day 7 but it's been 11 days the patient did not receive the second dose, which is considered as incomplete course of vaccination. Product dispensing error, product administration error, incomplete course of vaccination and syringe issue are considered as listed per company convention. The patient's medical history and concomitant medications details were not provided. Product dispensing error, product administration error, incomplete course of vaccination and syringe issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.