Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Product storage error, Wrong technique in product usage process
Clinical narrative: Jynneos administrated 8 weeks, 4 days after it was thawed; Jynneos administrated intradermally at a dose of 0.1 ml; Case reference number US-BN-2022-004185 is a spontaneous case report initially received on 12-Oct-2022 from nurse via Agency (reference number: USBAV22-1690) and concerns a male patient.  The patient's medical history and concomitant medications details were not provided.  On 12-Sep-2022, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00016) at a dose of 0.1 ml, administrated intradermally (explicitly coded as 'Intradermal injection'), for the indication reported as monkeypox/smallpox prophylaxis.  On 12-Oct-2022, 30 days after the first dose, the patient was vaccinated with a second dose of Jynneos vaccine (batch number: FPD00016) at a dose of 0.1 ml, administrated intradermally.  Nurse reported that it looked like vaccine expired 8 weeks after it has been thawed and added that someone administered it to the patient 8 weeks and 4 days after it was thawed. 08-Oct-2022 was the expiration date, and vaccine was administered on 12-Oct-2022 (explicitly coded as 'Expired product administered').  Additional information received on 12-Oct-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A male patient born in 1956 was vaccinated with the first dose of Jynneos vaccine on 12-Sep-22, at a dose of 0.1ml administered intradermally, which is coded as intradermal injection for monkeypox/smallpox prophylaxis. On 12-Oct-22, 30 days following the first dose, the patient was vaccinated with a second dose of Jynneos vaccine. The vaccine was also administered intradermally, at a dose of 0.1ml. Reportedly, 08-Oct-22 was the expiration date and vaccine was adminsitered on 12-Oct-22 which is considered expired product administered. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired product administered are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A male patient born in 1956 was vaccinated with the first dose of Jynneos vaccine on 12-Sep-22, at a dose of 0.1ml administered intradermally, which is coded as intradermal injection for monkeypox/smallpox prophylaxis. On 12-Oct-22, 30 days following the first dose, the patient was vaccinated with a second dose of Jynneos vaccine. The vaccine was also administered intradermally, at a dose of 0.1ml. Reportedly, 08-Oct-22 was the expiration date and vaccine was adminsitered on 12-Oct-22 which is considered expired product administered. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired product administered are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.