Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event, Product administered at inappropriate site
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; vaccine administered in left lower forearm; Case reference number US-BN-2022-003946 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 07-Oct-2022, the patient was vaccinated with a first 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'), *in left lower forearm (explicitly coded as 'vaccine administered at inappropriate site')*, 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-2022-003948 (same reporter).   Non-significant case correction performed for information received from Bavarian Nordic on 10-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, the patient's initials were provided and anatomical site of Jynneos vaccine administration was provided which led to capturing of an additional special situation.; Reporter's Comments: An adult male patient  was vaccinated with a first dose of Jynneos vaccine, administered intradermally at a dose of 0.1ml for monkeypox prophylaxis, in left forearm, which is considered intradermal injection and vaccine administered at inappropriate site. Reportedly, the nurse gave two vaccines out of a vial that had expired which is considered expired vaccine used. All events are assessed as listed per the Company conventions. The patient's medical history and concomitant medications details were not provided. The patient did not experience any adverse events due to Jynneos. Intradermal injection, vaccine administered at inappropriate site and expired vaccine used are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: An adult male patient born in 2000 was vaccinated with a first dose of Jynneos vaccine, administered intradermally at a dose of 0.1ml for monkeypox prophylaxis, in left forearm, which is considered intradermal injection and vaccine administered at inappropriate site. Reportedly, the nurse gave two vaccines out of a vial that had expired which is considered expired vaccine used. All events are assessed as listed per the Company conventions. The patient's medical history and concomitant medications details were not provided. The patient did not experience any adverse events due to Jynneos. Intradermal injection, vaccine administered at inappropriate site and expired vaccine used are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.