Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | Unknown | — |
The RabAvert was dispensed to the patient for self-injection and the patient disposed of the product without following proper destruction protocols; The RabAvert was dispensed to the patient for self-injection and the patient disposed of the product without following proper destruction protocols; Case reference number US-BN-2025-001750 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: Case-000436) on 28-Oct-2025 and concerns a female 39-years-old patient. The patient's medical history and concomitant medication details were not provided. On 21-Oct-2025, on day 0, the patient received the first dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration, for the indication of post exposure prophylaxis. On 24-Oct-2025, on day 3, the patient presented at the pharmacy for her second dose of RabAvert. The pharmacist dispensed the vaccine to the patient for self-administration, which is not aligned with the approved instructions for use, as RabAvert should be administered by a qualified healthcare professional (explicitly coded as 'product dispensing error'). After reconstitution of the RabAvert vaccine (batch number: FDP00721, expiration date: Jan-2028), the patient observed that the diluent appeared cloudy ("not clear" as reported) and became concerned. The healthcare professional on site decided not to administer the vaccine due to the unusual appearance of the product. The patient subsequently discarded the product instead of returning it to the pharmacy or manufacturer for evaluation. The patient disposed of the product without following proper destruction protocols (explicitly coded as 'incorrect disposal of product). The patient was instructed to obtain a replacement dose from a different pharmacy, which she did. The patient did not miss a dose and received it at another pharmacy. On 28-Oct-2025, on day 7, the patient received the third dose of RabAvert along with its constituent parts: prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown) at an unknown dose, route, or site of administration, for the indication of post exposure prophylaxis. On 04-Nov-2025, on day 14, the patient was scheduled to receive fourth dose of RabAvert. As the sample (FDP00721) has been discarded it is not possible to investigate the alleged issue thoroughly. However, a batch record review and retain sample check was conducted, and no irregularities were observed in relation to the appearance of the product. As no further investigations are possible, the PQC is deemed unsubstantiated. At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert treatment. The product quality complaint number received for this case was QE-019084. Additional information was received from reporter on 28-Oct-2025: New information included confirmation that item was thrown out. Additional information was received from reporter on 30-Oct-2025: New information included RabAvert dosing details (date of administration). Additional information was received from Bavarian Nordic on 30-Oct-2025: New information included details regarding RabAvert was dispensed to the patient for self-injection and patient disposed of the product without following proper destruction protocols. Additional information was received from Bavarian Nordic on 30-Oct-2025: New information included investigational summary results. Additional information was received from Bavarian Nordic on 31-Oct-2025: New information included reference number and event description added.; Reporter's Comments: A spontaneous case concerning, a 39 year old female patient received her first RabAvert dose on Day 0 for post exposure prophylaxis. On Day 3, the pharmacist dispensed the second dose for self administration, which was a dispensing error; the reconstituted product appeared cloudy (coded as product dispensing error and incorrect disposal of product) , so it was not administered and was incorrectly discarded. The patient obtained a replacement dose from another pharmacy and continued treatment without missing a dose. On Day 7, she received the third dose and was scheduled for the fourth dose on Day 14. The events product dispensing error and incorrect disposal of product are expected as per the company convention. However, the event assessed as not related to suspect vaccine but to human factor. The case is assessed as non-serious. For regulatory reporting purposes, this case is considered not related.; Sender's Comments: A spontaneous case concerning, a 39 year old female patient received her first RabAvert dose on Day 0 for post exposure prophylaxis. On Day 3, the pharmacist dispensed the second dose for self administration, which was a dispensing error; the reconstituted product appeared cloudy (coded as product dispensing error and incorrect disposal of product) , so it was not administered and was incorrectly discarded. The patient obtained a replacement dose from another pharmacy and continued treatment without missing a dose. On Day 7, she received the third dose and was scheduled for the fourth dose on Day 14. The events product dispensing error and incorrect disposal of product are expected as per the company convention. However, the event assessed as not related to suspect vaccine but to human factor. The case is assessed as non-serious. For regulatory reporting purposes, this case is considered not related.
Comments: None.