Received Jun 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA (VIMKUNYA) | BAVARIAN NORDIC | UNK | Unknown | — |
Multi X patient received Vimkunya which was not a homogenous white and cloudy solution; Multi X patient received Vimkunya which was not a homogenous white and cloudy solution; Case reference number US-BN-2026-000705 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-2026-000630) on 01-May-2026 and concerns unspecified number of patients (MULTI X) of unknown age and gender. The patient's medical history and concomitant medications details were provided. On an unspecified date, the patients received the two doses of Vimkunya vaccine, which had tiny white particles that dissolved and was not white and cloudy, along with its constituent parts prefilled syringe (batch number: unknown) at an unknown dose and 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 patients experienced any adverse event due to Vimkunya vaccine. No further information was provided.; Reporter's Comments: This case concerns an unspecified number of patients of unknown age and gender who received two doses of Vimkunya vaccine for an unknown indication. The product was reported to have had tiny white particles that dissolved and was not white and cloudy (explicitly coded as 'product administration error' and 'product quality issue'). At the time of initial report, it was unknown if the patients experienced any adverse event due to Vimkunya vaccine. The patients' medical history and concomitant medication details were not provided. Product administration error and product quality issue are considered as listed per company convention. These events are considered not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered not related.; Sender's Comments: This case concerns an unspecified number of patients of unknown age and gender who received two doses of Vimkunya vaccine for an unknown indication. The product was reported to have had tiny white particles that dissolved and was not white and cloudy (explicitly coded as 'product administration error' and 'product quality issue'). At the time of initial report, it was unknown if the patients experienced any adverse event due to Vimkunya vaccine. The patients' medical history and concomitant medication details were not provided. Product administration error and product quality issue are considered as listed per company convention. These events are considered not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered not related.
Comments: None.