Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | 96868 | IM / LA |
The patients received Jynneos vaccine which was stored at five degrees Celsius more than eight weeks; The patients received Jynnoes vaccine intramuscularly; The female patient received one dose of Jynneos vaccine; Case reference number US-BN-2025-000426 is a spontaneous case initially received from physician via Communication (reference number: USBAV25-0743) on 03-APR-2025 and concerns a *61-years-old* male and *40-years-old* female patient (MULTI 2). The patient's medical history and concomitant medication details were not provided. On an unspecified date, the vaccine was probably not stored correctly, since when arrived in facility it was not thawed. After that vaccine is stored in the refrigerator on temperature about five degrees Celsius more than eight weeks. *On 30-Dec-2024, the male patient received a first dose of defected Jynneos vaccine (batch number: 96868 and expiration date: Apr-2026), at 0.5 ml, intramuscularly on left deltoid (explicitly coded as 'expired vaccine used' and 'incorrect route of product administration').* On 29-Jan-2025, * 30 days after first dose, the male* patient received a *second* dose of defected Jynneos vaccine (batch number: *96868 and expiration date: Apr-2026), at 0.5 ml, intramuscularly on left deltoid* (explicitly coded as 'expired vaccine used' and *'incorrect route of product administration'*). *On 12-Feb-2025, the female patient received a dose of defected Jynneos vaccine (batch number: *96868 and expiration date: Apr-2026), at 0.5 ml, intramuscularly on right deltoid * (explicitly coded as 'expired vaccine used', *'incorrect route of product administration' and 'incomplete course of vaccination' *). At the time of the initial report, it was unknown if patients experienced any adverse events due to Jynneos. Additional information received from physician via Communication (reference number: USBAV25-0745) included: confirmation for gender of second patient and additional reference number. Follow up information received from a pharmacist on 01-May-2025: New information included dosing information and patients details. Non-significant follow up received from physician on 15-May-2025 included new reporter information.; Reporter's Comments: This case report concerns 61-year-old male and 40-year-old female patient. Reportedly, the vaccine was probably not stored correctly, since when arrived in facility it was not thawed. After that vaccine is stored in the refrigerator on temperature about five degrees Celsius more than eight weeks. The male patient received the first dose of defected Jynneos vaccine, intramuscularly, which is considered as expired vaccine used and incorrect route of product administration. 30 days after first dose, the male patient received the second dose of defected Jynneos vaccine intramuscularly, which is considered as expired vaccine used and incorrect route of product administration. The female patient received a dose of defected Jynneos vaccine intramuscularly, which is considered as expired vaccine used, incorrect route of product administration and incomplete course of vaccination It was unknown if patients experienced any adverse events due to Jynneos. Expired product administered, incorrect route of product administration and incomplete course of vaccination are considered listed per company convention. 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: This case report concerns 61-year-old male and 40-year-old female patient. Reportedly, the vaccine was probably not stored correctly, since when arrived in facility it was not thawed. After that vaccine is stored in the refrigerator on temperature about five degrees Celsius more than eight weeks. The male patient received the first dose of defected Jynneos vaccine, intramuscularly, which is considered as expired vaccine used and incorrect route of product administration. 30 days after first dose, the male patient received the second dose of defected Jynneos vaccine intramuscularly, which is considered as expired vaccine used and incorrect route of product administration. The female patient received a dose of defected Jynneos vaccine intramuscularly, which is considered as expired vaccine used, incorrect route of product administration and incomplete course of vaccination It was unknown if patients experienced any adverse events due to Jynneos. Expired product administered, incorrect route of product administration and incomplete course of vaccination are considered listed per company convention. 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