Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | FDP00757 | — |
exposure of RabAvert to the nurses' hands; plunger of the syringe popped out causing the loss of the product within the syringe.; plunger of the syringe popped out causing the loss of the product within the syringe.; Case reference number US-BN-2026-000722 is a spontaneous case initially received from other health professional via Bavarian Nordic (reference number: QE-022361) on 04-May-2026 and concerns a female patient (affected nurse) of an unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00687) could not be administered to the patient due to the plunger popping out of the syringe after reconstitution, with a loud pop which was not anticipated. There was exposure of the vaccine to the nurse's hands, which she washed immediately. As reported, there were no open sores noted to the hands and and no exposure to the face, eyes, and mouth (explicitly coded as ' accidental occupational exposure to product ', 'device plunger issue' and 'syringe leak'). As reported, there was no delay in vaccination schedule for the patient. *As reported, the investigation has been completed. The syringe was carefully inspected and found to be free from any visible defects or abnormalities. The diluent and vial were both empty, and the back stopper was not present in the returned package. During functional assessment and simulation testing using water, the syringe performed as expected, and no leakage or plunger expulsion could be reproduced. Based on these findings, the most probable cause of the event is that the back stopper was not fully or securely attached prior to use. If the back stopper is not correctly positioned, it may allow the plunger and stopper assembly to be forced out of the syringe during reconstitution, which can result in leakage.* At the time of the initial report, it was unknown if the affected nurse experienced any adverse events due to RabAvert. The product quality complaint number was (QE-022361). Additional information received from other health professional on 06-May-2026. Information included: additional events, patient information. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from Bavarian Nordic on 02-Jun-2025 included: investigation summary results.; Reporter's Comments: A female patient (affected nurse) of an unknown age was exposed to the RabAvert vaccine on her hands, which she washed immediately. Reportedly, there were no open sores noted to the hands and and no exposure to the face, eyes, and mouth which is currently considered as accidental occupational exposure to product, device plunger issue and syringe leak. There was no delay in vaccination schedule for the patient. Accidental exposure to product, device issue and syringe issue are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, it was unknown if the affected nurse experienced any adverse events due to RabAvert. Accidental exposure to product, device issue and syringe issue are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient (affected nurse) of an unknown age was exposed to the RabAvert vaccine on her hands, which she washed immediately. Reportedly, there were no open sores noted to the hands and and no exposure to the face, eyes, and mouth which is currently considered as accidental occupational exposure to product, device plunger issue and syringe leak. There was no delay in vaccination schedule for the patient. Accidental exposure to product, device issue and syringe issue are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, it was unknown if the affected nurse experienced any adverse events due to RabAvert. Accidental exposure to product, device issue and syringe issue are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.