Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Two vaccines out of a vial that had expired. It had been opened longer than 8 hours.; Jynneos administrated intradermally at a dose of 0.1 ml; Case reference number US-BN-2022-003948 is a spontaneous case report initially received on 07-Oct-2022 from nurse via Communications (reference number: USBAV22-1660) and concerns an adult male patient.  The patient's medical history and concomitant medications details were not provided.  On 09-Sep-2022, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, unknown route of administration, for monkeypox prophylaxis.  On 07-Oct-2022, 28 days after the first dose of Jynneos was administrated, the patient was vaccinated with a second dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00019) at a dose of 0.1 ml, administered intradermally (ID), (explicitly coded as 'intradermal injection'), for monkeypox prophylaxis.  As reported, nurse gave two vaccines out of a vial that had expired to two patients. It had been opened longer than eight hours, (explicitly coded as 'expired vaccine used').  At the time of this report, *the patient did not experience any adverse event due to Jynneos*.  This case is linked with case US-BN-2022-003946 (same reporter).   Non-significant case correction performed for information received from Bavarian Nordic on 17-Oct-2022 to include local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a nurse on 26-Oct-2022 included confirmation that no adverse event occurred due to Jynneos vaccine and the patient's initials were provided.; Reporter's Comments: An adult male patient,  received his first dose of Jynneos, applied via unknown route or site, for monkeypox prophylaxis. 28 days later, the patient received the second dose of Jynneos, applied at a 0.1 ml dose intradermally (explicitly coded as intradermal injection). Reportedly, the vaccine vial had been kept open for longer than 8 h and had expired - which is considered expired vaccine used. No associated adverse events were reported with this medication error. Expired vaccine used and intradermal injection are considered listed per company convention. The patient's medical history and concomitant medications were not reported. Expired vaccine used and intradermal injections are considered not related to Jynneos, but to human factor. The case is non-serious.; Sender's Comments: An adult male patient, born in 2000, received his first dose of Jynneos, applied via unknown route or site, for monkeypox prophylaxis. 28 days later, the patient received the second dose of Jynneos, applied at a 0.1 ml dose intradermally (explicitly coded as intradermal injection). Reportedly, the vaccine vial had been kept open for longer than 8 h and had expired - which is considered expired vaccine used. No associated adverse events were reported with this medication error. Expired vaccine used and intradermal injection are considered listed per company convention. The patient's medical history and concomitant medications were not reported. Expired vaccine used and intradermal injections are considered not related to Jynneos, but to human factor. The case is non-serious.