Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Incorrect route of product administration, Product administration error
Clinical narrative: Jynneos was administered nine weeks after being thawed; Jynneos was administered nine weeks after being thawed; Case reference number US-BN-2022-004623 is a spontaneous case initially received on 08-Nov-2022 from a nurse via Communication (reference number: USBAV22-1892) and concerns an adult male patient born in 1991.  Patient's medical history and concomitant medication details were not provided.  On 21-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00002), at a dose 0.5 mL, administered subcutaneously, for monkeypox prophylaxis.  On 19-Oct-2022, 28 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00002), at a dose 0.5 mL, administered subcutaneously. As reported, this vial was administered seven days after the expiry date, which was nine weeks after the vaccine was thawed (explicitly coded as 'expired vaccine used' and 'product administration error').  On 25-Oct-2022, 34 days after the first dose, the patient was vaccinated with the third dose of Jynneos (batch number FDP00002), at a dose 0.5 mL, administered subcutaneously.  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received from on 08-Nov-2022 included the local case ID.; Reporter's Comments: An adult male patient was vaccinated with the second dose (0.5 mL) of Jynneos (28 days after the first dose), administered subcutaneously, with a vial that expired seven days before the vaccination (nine weeks after the vaccine was thawed) which is considered as expired vaccine used and product administration error. 34 days after the first dose, the patient was vaccinated with the third dose of Jynneos, at a dose 0.5 mL, administered subcutaneously. Product administration error and expired product administered are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events. Patient's medical history and concomitant medication details were not provided. Product administration error and expired product administered are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the second dose (0.5 mL) of Jynneos (28 days after the first dose), administered subcutaneously, with a vial that expired seven days before the vaccination (nine weeks after the vaccine was thawed) which is considered as expired vaccine used and product administration error. 34 days after the first dose, the patient was vaccinated with the third dose of Jynneos, at a dose 0.5 mL, administered subcutaneously. Product administration error and expired product administered are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events. Patient's medical history and concomitant medication details were not provided. Product administration error and expired product administered are both assessed as not related to suspect product but to human factor. The case is non-serious.