Confirmed case of monkeypox; 12-year-old vaccinated with Jynneos; Case reference number US-BN-2022-004822 is a spontaneous case report initially received from other health care professional via Bavarian Nordic on 30-Nov-2022 and concerns a 12-year-old female patient.  The patient's concurrent medical history included lesions, present at the time of vaccination.  The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live modified vaccinia virus ankara; batch number not provided) at an unknown dose, route or site of administration for close contact exposure with monkeypox case (explicitly coded as 'off label use').  On an unspecified date, an unknown amount of time after the vaccination, the patient experienced monkeypox.  At the time of this report, the outcome of the event was unknown.  The reporter did not provide seriousness or causality assessment. The event 'monkeypox' was assessed as serious, due to the seriousness criteria of medical significance.  Additional information received from Bavarian Nordic on 05-Dec-2022 included confirmation of the country of occurrence.  The case is linked with US-BN-2022-004823, US-BN-2022-004824, US-BN-2022-004825, US-BN-2022-004826 and US-BN-2022-004827 (same reporter).; Reporter's Comments: A 12-year-old female patient was vaccinated with Jynneos, at an unknown dose, route or site of administration for close contact exposure with monkeypox case, which is considered as off label use. Reportedly, on an unspecified date, an unknown amount of time after the vaccination, the patient experienced a serious event of monkeypox (medical significance). The event of monkeypox is unlisted for Jynneos according to the CCDS v1 and PI. However, vaccines are not necessarily protective in 100% of cases. Off label use is considered as listed per company convention. The patient's concurrent medical history included lesions, present at the time of vaccination and concomitant medication details were not provided. Reportedly, the outcome of the event was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Off label use has been considered as not related to the suspect vaccine, but to a human factor.; Sender's Comments: A 12-year-old female patient was vaccinated with Jynneos, at an unknown dose, route or site of administration for close contact exposure with monkeypox case, which is considered as off label use. Reportedly, on an unspecified date, an unknown amount of time after the vaccination, the patient experienced a serious event of monkeypox (medical significance). The event of monkeypox is unlisted for Jynneos according to the CCDS v1 and PI. However, vaccines are not necessarily protective in 100% of cases.  Off label use is considered as listed per company convention. The patient's concurrent medical history included lesions, present at the time of vaccination and concomitant medication details were not provided. Reportedly, the outcome of the event was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. Off label use has been considered as not related to the suspect vaccine, but to a human factor.