Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Incorrect route of product administration, Product administered at inappropriate site, Product administration error
Clinical narrative: An expired dose of Jynneos was given to a patient; An expired dose of Jynneos was given to a patient; Jynneos vaccine administered intradermally; Jynneos vaccine administered in lower left arm; Case reference number US-BN-2022-004703 is a spontaneous case report initially received on 14-Oct-2022 from a nurse via agency (reference number: USBAV22-1704) and concerns a 40-year-old born male patient but identifies as a female, trans as reported.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: Unknown) at unknown dose, administered via an unknown route of administration at unknown anatomical location, for monkeypox prophylaxis.  On 12-Oct-2022, an unknown amount of time after the vaccination, an expired second dose of Jynneos vaccine (batch number: FDP00020) was administered, at an unknown dose, intradermally in lower left arm, for monkeypox prophylaxis (explicitly coded as 'Expired vaccine used', 'Product administration error', 'Intradermal injection' and 'Vaccine administered at inappropriate site').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from a nurse on 15-Nov-2022 included patient's details, date of vaccination with second Jynneos dose, batch number, route of administration and anatomical location.  This case is linked with the case US-BN-2022-004202 (same reporter).  Non-significant case correction received from Bavarian Nordic on 17-Nov-2022 included local BN case ID.; Reporter's Comments: A 40-year-old born male patient but identifies as a female, trans as reported, was vaccinated with the first dose of Jynneos vaccine at unknown dose, administered via an unknown route of administration at unknown anatomical location, for monkeypox prophylaxis. An unknown amount of time after the vaccination, an expired second dose of Jynneos vaccine was administered, at an unknown dose, intradermally in lower left arm, for monkeypox prophylaxis, which is considered as expired product administered, product administration error and vaccine administered at inappropriate site. No associated adverse events were reported. Expired product administered, product administration error, intradermal injection and vaccine administered at inappropriate site are all listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered, product administration error, intradermal injection and vaccine administered at inappropriate site are all assessed as not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A 40-year-old born male patient but identifies as a female, trans as reported, was vaccinated with the first dose of Jynneos vaccine at unknown dose, administered via an unknown route of administration at unknown anatomical location, for monkeypox prophylaxis. An unknown amount of time after the vaccination, an expired second dose of Jynneos vaccine was administered, at an unknown dose, intradermally in lower left arm, for monkeypox prophylaxis, which is considered as expired product administered, product administration error and vaccine administered at inappropriate site. No associated adverse events were reported. Expired product administered, product administration error, intradermal injection and vaccine administered at inappropriate site are all listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered, product administration error, intradermal injection and vaccine administered at inappropriate site are all assessed as not related to Jynneos, but to a human factor. The case is non-serious.