Sex: M
Vaccine: UNK
Symptoms: Headache, Infection, Laboratory test abnormal, Monkeypox, Myalgia
Clinical narrative: Breakthrough infection was observed in a patient, 58 days after the first dose; Rectal gonorrhea; Patient tested positive for monkeypox 58 days after receiving the first dose of the MVA-BN; Breakthrough infection was observed in a patient, 58 days after the first dose;   Case reference number US-BN-2022-004055 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 (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. At least two breakthrough infections were observed in individuals at least three weeks after a second dose. One patient had a breakthrough infection 58 days after the first dose that is, 27 days after the second dose, the patient had systemic symptoms like fevers, chills, myalgias and headache, perianal and penile lesions (less than 10) and rectal 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-2022-004054, 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 the serious (medically significant) event of breakthrough infection, 58 days after the first dose, equivalent to 27 days after the second dose of MVA-BN, and serious event gonorrhoea (medically significant) on unspecified day. Reportedly, the patient had systemic symptoms like fevers, chills, myalgias and headache, perianal and penile lesions. Breakthrough infection and gonorrhoea are unlisted per the CCDS V1.0 and USPI for MVA-BN. Medical history and concomitant medications information was not available. Considering that the vaccine is non-replicating and does not contain monkeypox virus, the event of is assessed as not related to MVA-BN. Gonorrhoea has also been considered not related to MVA-BN vaccine, due to biological implausibility. This case may represent a breakthrough infection since it occurred more than 3 weeks after the second dose.; Sender's Comments: An adult male patient of unknown age developed the serious (medically significant) event of breakthrough infection, 58 days after the first dose, equivalent to 27 days after the second dose of MVA-BN, and serious event gonorrhoea (medically significant) on unspecified day. Reportedly, the patient had systemic symptoms like fevers, chills, myalgias and headache, perianal and penile lesions. Breakthrough infection and gonorrhoea are unlisted per the CCDS V1.0 and USPI for MVA-BN. Medical history and concomitant medications information was not available. Considering that the vaccine is non-replicating and does not contain monkeypox virus, the event of is assessed as not related to MVA-BN. Gonorrhoea has also been considered not related to MVA-BN vaccine, due to biological implausibility. This case may represent a breakthrough infection since it occurred more than 3 weeks after the second dose.