Sex: M
Vaccine: UNK
Symptoms: Genital lesion, Incomplete course of vaccination, Monkeypox, Orthopoxvirus test positive, Penis disorder
Clinical narrative: Patient tested positive for monkeypox 35 days after receiving the first dose of the MVA-BN; It was confirmed that the patient didn't receive second dose; Literature citation:   Case reference number US-BN-2022-004051 is a literature case report, title as stated above, identified on 11-Oct-2022 and concerns an adult male patient of unknown age.  The clinic began administering MVA-BN (modified vaccinia ankara  bavarian nordic live virus (live-attenuated, non-replicating) to eligible individuals on 28-Jun-2022. Patients who tested positive for monkeypox at least 1 day after receiving the first dose of the MVA-BN from 28-Jun-2022, through 9-Sep-2022, were included. During the study period, 400 patients tested positive for monkeypox, and 7339 individuals received their first dose of MVA-BN. Ninety patients tested positive for monkeypox at least 1 day after vaccination with a median age of 33 years ( range, 24-69 years); 91 percent were men, 37.8 percent were living with HIV, and 73.5 percent had viral loads less than 200 copies/mL.  Eight monkeypox cases occurred more than 28 days from the first dose of MVA-BN, of which 2 cases occurred more than 14 days from the second dose. All 8 patients self-identified as males, 50 percent (4/8) had HIV, all of whom were virologically suppressed. All patients except 1 had fewer than 10 lesions. One monkeypox case occurred 35 days after the first dose, the patient had penile lesions (less than 10), lesions on the back, rectal pain and didn't receive the second dose (explicitly coded as 'missed dose').  This case is linked to the cases US-BN-2022-004048, US-BN-2022-004050, US-BN-2022-004052, US-BN-2022-004053, US-BN-2022-004054, US-BN-2022-004055, US-BN-2022-004056 and US-BN-2022-004059 (same reporter).  Additional information received from Bavarian Nordic on 11-Oct-2022 included local BN case ID.; Reporter's Comments: An adult male patient of unknown age developed serious event monkeypox (medically significant) 35 days after the first dose of MVA-BN vaccine was administered. The patient didn't receive the second dose, which is considered missed dose. Missed dose is listed by convention. Monkeypox is unlisted per the CCDS v1 and the USPI. Reportedly, the patient had penile lesions, lesions on the back and rectal pain. Concomitant medications and medical history were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to MVA-BN. Missed dose is not related to MVA-BN, but to a human factor.; Sender's Comments: An adult male patient of unknown age developed serious event monkeypox (medically significant) 35 days after the first dose of MVA-BN vaccine was administered. The patient didn't receive the second dose, which is considered missed dose. Missed dose is listed by convention. Monkeypox is unlisted per the CCDS v1 and the USPI. Reportedly, the patient had penile lesions, lesions on the back and rectal pain. Concomitant medications and medical history were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to MVA. Furthermore, the recommended standard dose regimen was not given. Missed dose is not related to MVA-BN, but to a human factor.