Sex: M
Vaccine: UNK
Symptoms: Orthopoxvirus test positive, Proctalgia, Pyrexia, Rectal haemorrhage
Clinical narrative: Patient tested positive for monkeypox 37 days after receiving the first dose of the MVA-BN; Literature citation:  Case reference number US-BN-2022-004053 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 37 days after the first dose that is, 7 days after the second dose, the patient had systemic symptoms like fevers, fatigue and lymphadenopathy, perianal and intra-anal lesions, and rectal pain and bleeding. The patient was given tecovirimat antiviral therapy due to severity of anogenital symptoms.   This case is linked to the cases US-BN-2022-004048, US-BN-2022-004050, US-BN-2022-004051, US-BN-2022-004052, 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) 37 days after the first dose, and 7 days after the second dose of MVA-BN vaccine was administered. Monkeypox is unlisted per the CCDS v1 and the USPI. Reportedly, the patient had systemic symptoms like fevers, fatigue and lymphadenopathy, perianal and intra-anal lesions, and rectal pain and bleeding. 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.; Sender's Comments: An adult male patient of unknown age developed serious event monkeypox (medically significant) 37 days after the first dose, and 7 days after the second dose of MVA-BN vaccine was administered. Monkeypox is unlisted per the CCDS v1 and the USPI. Reportedly, the patient had systemic symptoms like fevers, fatigue and lymphadenopathy, perianal and intra-anal lesions, and rectal pain and bleeding. 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. In this small study, the majority of postvaccination monkeypox infections occurred within 2 weeks of receiving the first dose of MVA-BN, before full effectiveness was likely to have been achieved, in line with published immunogenicity data. Because the incubation period for monkeypox is 3 to 17 days, this case may not represent true vaccine failure because patients may have sought vaccination after realizing they were exposed.