Received Apr 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA (VIMKUNYA) | BAVARIAN NORDIC | UNK | Unknown | — |
the Vimkunya vaccine wasn't white and cloudy. It was clear. The vaccine was already administered to the patient; the Vimkunya vaccine wasn't white and cloudy. It was clear. The vaccine was already administered to the patient; Case reference number US-BN-2025-002015 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-001199) on 15-Dec-2025 and concerns a patient of an unknown age and gender. The patient's medical history and concomitant medications details were provided. On an unspecified date, the vaccine should be shaken and should be "white cloudy" however the nurse did the procedure, and the vaccine wasn't white and cloudy, it was clear, the patient received the dose of Vimkunya vaccine along with its constituent parts prefilled syringe (batch number: unknown), dose, route for an unknown indication (explicitly coded as 'product administration error' and 'product quality issue'). At the time of initial report, it was unknown if the patient experienced any adverse evet due to Vimkunya vaccine. Additional information received on 29-Dec-2025: New information included confirmation of country of occurrence.; Reporter's Comments: This case concerns a patient of an unknown age and gender, who received a dose of Vimkunya for an unknown indication. As reported, Vimkunya vaccine, after shaking, the suspension should be a white, cloudy liquid. But it was clear, which is considered as 'product quality issue' and 'product administration error'. Product quality issue and product administration error are considered as listed per company convention. At the time of initial report, it was unknown if the patient experienced any adverse evet due to Vimkunya vaccine. The patient's relevant medical history and concomitant medication details were not provided. Product quality issue and Product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a patient of an unknown age and gender, who received a dose of Vimkunya for an unknown indication. As reported, Vimkunya vaccine, after shaking, the suspension should be a white, cloudy liquid. But it was clear, which is considered as 'product quality issue' and 'product administration error'. Product quality issue and product administration error are considered as listed per company convention. At the time of initial report, it was unknown if the patient experienced any adverse evet due to Vimkunya vaccine. The patient's relevant medical history and concomitant medication details were not provided. Product quality issue and Product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.