Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | Unknown | — |
The patients had not come in for their second dose yet; Case reference number US-BN-2025-000016 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-0028) on 06-Jan-2025 and concerns two male patients of unspecified age (MULTI 2). The patient's relevant medical history and concomitant medications were not provided. On 25-Oct-2024, the second patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication. On 28-Oct-2024, the first patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication. As reported, the patients had not come in for their second dose of Jynneos yet (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. Additional information received from pharmacist via Med Communications (reference number: USBAV25-0029) on 08-Jan-2025: Information included reference number and confirmation there was two male patients. Non-significant case correction received from VAERS on 14-Feb-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20250106-f17299 to US-BAVARIAN NORDIC A/S-US-BN-2025-000016, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: Two male patients of unspecified age did not receive the second dose of Jynneos yet in Jan-2025, after they were vaccinated with the first dose in Oct-2024, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two male patients of unspecified age did not receive the second dose of Jynneos yet in Jan-2025, after they were vaccinated with the first dose in Oct-2024, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.