Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Product administration error
Clinical narrative: One patient received the vaccine one day after the expiration date, and the other one week after the expiration date; One patient received the vaccine one day after the expiration date, and the other one week after the expiration date; Jynneos was administered intradermally; Case reference number US-BN-2022-004942 is a spontaneous case report initially received from other health care professional via  Communication (reference number: USBAV22-2185) on 22-Dec-2022 and concerns two patients of unknown demographics.  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patients were vaccinated with an expired dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP0009) administered intradermally (explicitly coded as 'intradermal injection') at a dose of 0.1 mL, at an unknown site of administration for monkeypox prophylaxis (explicitly coded as 'expired vaccine used' and 'product administration error'). As reported, one patient received the vaccine one day after the expiration date and the other one week after the expiration date.   At the time of this report, it was unknown if any patient experienced any adverse event due to Jynneos vaccination.   Additional information received from Bavarian Nordic on 23-Dec-2022 included local BN case ID.; Reporter's Comments: Two patients of unknown demographics were vaccinated with an expired dose of Jynneos vaccine administered intradermally (considered as intradermal injection) at a dose of 0.1 mL, at an unknown site of administration for monkeypox prophylaxis (considered as expired vaccine used and product administration error). Reportedly, one patient received the vaccine one day after the expiration date and the other one week after the expiration date. Expired product administered, product administration error and injection are all considered listed per company conventions. At this point, it was unknown if any patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medication details were not provided. Causality (for expired product administered, product administration error and injection) is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: Two patients of unknown demographics were vaccinated with an expired dose of Jynneos vaccine administered intradermally (considered as intradermal injection) at a dose of 0.1 mL, at an unknown site of administration for monkeypox prophylaxis (considered as expired vaccine used and product administration error). Reportedly, one patient received the vaccine one day after the expiration date and the other one week after the expiration date. Expired product administered, product administration error and injection are all considered listed per company conventions. At this point, it was unknown if any patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medication details were not provided. Causality (for expired product administered, product administration error and injection) is assessed as not related to suspect product but to human factor. The case is non-serious.