Sex: M
Vaccine: UNK
Symptoms: Anorectal disorder, Fatigue, Gonorrhoea, Headache, Lymphadenopathy
Clinical narrative: Patient tested positive for monkeypox 46 days after receiving the first dose of the MVA-BN; Oropharyngeal gonorrhea; Literature citation:  Case reference number US-BN-2022-004054 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 46 days after the first dose that is, 11 days after the second dose. The patient had systemic symptoms like fatigue, lymphadenopathy and headache, perianal lesion (less than 10), rectal pain, lesions on forearms and legs, and oropharyngeal gonorrhea.   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-2022-004053, 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) 46 days after the first dose and 11 days after the second dose of MVA-BN vaccine was administered, and serious event oropharyngeal gonorrhea (medically significant) on unspecified day. Monkeypox and oropharyngeal gonorrhea are unlisted per the CCDS v1 and the USPI. Reportedly, the patient had systemic symptoms like fatigue, lymphadenopathy and headache, less than ten perianal lesions, rectal pain, lesions on forearms and legs. 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. Oropharyngeal gonorrhea has also been considered not related to MVA-BN vaccine, due to biological implausibility.; Sender's Comments: An adult male patient of unknown age developed serious event monkeypox (medically significant) 46 days after the first dose and 11 days after the second dose of MVA-BN vaccine was administered, and serious event oropharyngeal gonorrhea (medically significant) on unspecified day. Monkeypox and oropharyngeal gonorrhea are unlisted per the CCDS v1 and the USPI. Reportedly, the patient had systemic symptoms like fatigue, lymphadenopathy and headache, less than ten perianal lesions, rectal pain, lesions on forearms and legs. 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.  Oropharyngeal gonorrhea has also been considered not related to MVA-BN vaccine, due to biological implausibility.