Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Patient received Jynneos vaccine three days after eight week thaw date; Case reference number US-BN-2024-002508 is a spontaneous case initially received from health care professional via Communication (reference number: USBAV24-2406) on 17-Sep-2024 and concerns a patient of unspecified age or gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with the dose of Jynneos (batch number: unknown), at an unknown dose, route and site of administration for unknown indication. As reported patient received Jynneos vaccine three days after eight-week thaw date (explicitly coded as 'expired vaccine used'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Jynneos. Non-significant case correction identified on 04-Nov-2024 included new additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240917-6bfa1e to US-BAVARIAN NORDIC A/S-US-BN-2024-002508, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unspecified age or gender was vaccinated with the dose of Jynneos, at an unknown dose, route and site of administration for unknown indication. Reportedly, the patient received Jynneos vaccine three days after eight-week thaw date which is considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age or gender was vaccinated with the dose of Jynneos, at an unknown dose, route and site of administration for unknown indication. Reportedly, the patient received Jynneos vaccine three days after eight-week thaw date which is considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.