First and only dose of Jynneos was administered on the 14-Jul-2022; Monkeypox; Case reference number US-BN-2022-002594 is a spontaneous case report initially received on 15-Sep-2022 from a consumer via Bavarian Nordic and concerns a male patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was exposed to monkeypox.  On 14-Jul-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, route or site of administration for monkeypox.  On 15-Jul-2022, one day after the first dose of Jynneos, the patient developed symptoms of monkeypox.  It was confirmed that the patient did not receive further doses of Jynneos (explicitly coded as 'incomplete course of vaccination').  On an unspecified date, also reported as about four weeks after initial symptoms, the patient recovered from the event of monkeypox.  The reporter did not provide seriousness assessment. However, the event of 'monkeypox' was assessed as serious due to the seriousness criteria of medical significance. Causality assessment was not provided.  No further information was provided.  This case is linked with US-BN-2022-001595, US-BN-2022-002593 and US-BN-2022-002595.; Reporter's Comments: A male patient of an unknown age experienced a serious event of monkeypox (medically significant) on the day 1 after the patient was vaccinated with the first dose of Jynneos at an unknown dose, route, or site of administration for monkeypox. Reportedly, earlier on an unspecified date, the patient was exposed to monkeypox. It was confirmed that the patient did not receive further doses, which is considered as incomplete course of vaccination. The event of monkeypox is unlisted for Jynneos according to the agency, while incomplete course of vaccination is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event of monkeypox. Monkeypox has been considered as not related to the suspect vaccine, but to a viral infection, while incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor.; Sender's Comments: A male patient of an unknown age experienced a serious event of monkeypox (medically significant) on the day 1 after the patient was vaccinated with the first dose of Jynneos at an unknown dose, route, or site of administration for monkeypox. Reportedly, earlier on an unspecified date, the patient was exposed to monkeypox. It was confirmed that the patient did not receive further doses, which is considered as incomplete course of vaccination. The event of monkeypox is unlisted for Jynneos according to the agency, while incomplete course of vaccination is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event of monkeypox. Monkeypox has been considered as not related to the suspect vaccine, but to a viral infection, while incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor.