Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
The Jynneos vaccine was improperly stored in the refrigerator upon arrival; The patients were accidentally received a dose of Jynneos vaccine after 4 week period which was improperly stored in the refrigerator; The patients were accidentally received a dose of Jynneos vaccine after 4 week period which was improperly stored in the refrigerator; Case reference number US-BN-2025-000169 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV25-0207) on 28-Jan-2025 and concerns five patients of unspecified age and gender (Multi 5). The patient's medical history and concomitant medication details were not provided. On unspecified date in Sep-2024, the pharmacy received a shipment of Jynneos (NDC: 50632-0001-03). On an unknown date, upon arrival, the vaccine was improperly stored in the refrigerator (explicitly coded as 'product storage error'). On an unspecified date, the five patients accidentally received improperly stored Jynneos vaccines after 4 week period (batch number: unknown) at unknown dose, route or site administration for unknown indication (explicitly coded as 'product administration error' and 'expired vaccine used'). At the time of the initial report, it was unknown if the patients experienced any adverse event due to Jynneos vaccine. Additional information received from pharmacist on 29-Jan-2025 included: confirmed that five patients received improperly stored Jynneos vaccine.; Reporter's Comments: This case concerns five patients of unspecified age and gender who accidentally received improperly stored Jynneos vaccines after 4 week period at unknown dose, route or site administration for unknown indication which is considered as product administration error and expired vaccine used. Reportedly, the vaccine was improperly stored in the refrigerator which is considered as product storage error. Product storage error, product administration error and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns five patients of unspecified age and gender who accidentally received improperly stored Jynneos vaccines after 4 week period at unknown dose, route or site administration for unknown indication which is considered as product administration error and expired vaccine used. Reportedly, the vaccine was improperly stored in the refrigerator which is considered as product storage error. Product storage error, product administration error and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None