Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | 96867 | — |
Last week two individuals were vaccinated using Jynneos that should have been marked with a BUD but was not, the shipment was placed in refrigerator, BUD was on 20-Dec-2024; Case reference number US-BN-2025-000126 is a spontaneous case initially received from other health care professional via Med Communication (reference number: USBAV25-0116) on 15-Jan-2025 and concern a patients with unspecified age and gender (MULTI 2). The patients medical history and concomitant medication details were not provided. On 09-Jan-2025, two patients received Jynneos vaccine, (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 (explicitly coded as 'Expired product administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos. No further information was provided.; Reporter's Comments: This case concerns two patients with unspecified age and gender who received Jynneos vaccine on 09-Jan-2025 (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 which is considered as expired product administered. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due Jynneos. The patients 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: This case concerns two patients with unspecified age and gender who received Jynneos vaccine on 09-Jan-2025 (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 which is considered as expired product administered. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due Jynneos. The patients 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