Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | Unknown | — |
The patient received a dose of Jynneos vaccine three days past the eight-week period after thawing which was shelf life for the Jynneos after removing out of the fridge; Case reference number US-BN-2024-002507 is a spontaneous case report initially received from a nurse via agency (reference number USBAV24-2404) on 17-Sep-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported three days past eight weeks after thawing which was the shelf life for the Jynneos after removed out of the fridge, the patient received a dose of Jynneos (batch number: unknown), at an unknown dose, route, or site of administration, for unknown indication (explicitly coded as 'expired vaccine used'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. Non-significant case correction identified on 04-Nov-2024 included: new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240917-c2bcba to US-BAVARIAN NORDIC A/S-US-BN-2024-002507, in accordance with guidance on WWID formatting.; Reporter's Comments: A patient of unknown demographics received a dose of Jynneos, three days past eight weeks after thawing which was the shelf life for the Jynneos after removed out of the fridge, at an unknown dose, route, or site of administration, for unknown indication which is considered as expired vaccine used. Expired product administered is considered listed per company conventions. At this point it was unknown if the patient experienced any adverse event due to Jynneos vaccine. 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 unknown demographics received a dose of Jynneos, three days past eight weeks after thawing which was the shelf life for the Jynneos after removed out of the fridge, at an unknown dose, route, or site of administration, for unknown indication which is considered as expired vaccine used. Expired product administered is considered listed per company conventions. At this point it was unknown if the patient experienced any adverse event due to Jynneos vaccine. 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