Sex: U
Vaccine: SMALLMNK
Symptoms: Blood HIV RNA, CD4 lymphocytes increased, Incomplete course of vaccination, Monkeypox
Clinical narrative: Monkeypox; Received one dose of Jynneos vaccine; Literature citation:  Case reference number US-BN-2023-000892 is a literature case report, titled as stated above, identified on 16-May-2023 and concerns an adult patient of unknown gender, first out of three (median age 38, between 29-45).  The aim of the article was to describe monkeypox (mpox) among people with human immunodeficiency virus who received more than 14 days of tecovirimat (brand name unknown) and/or co-administration of additional mpox treatments and since the monkeypox clinical course during the 2022 outbreak was poorly understood.   11 patients were identified with persistent or worsening mpox during tecovirimat treatment through healthcare providers who called Department of Health or Centers for Disease Control and Prevention's clinical team for consultation between 02-Aug-2022 and 16-Dec-2022.  Demographics and HIV/mpox clinical information was collected and cases were crossmatched with DOHMH HIV surveillance for CD4 and viral load (VL) and Immunization Registry for Jynneos vaccination.  . Median HIV VL was 237,000 copies/mL (range: 73,000-2 million). All had CD4 less than 200 cells/mm3 while eight (73 percent) had CD4 less than 50 cells/mm3. On an unspecified date, first out of three patients received one dose of Jynneos vaccine (batch number unknown), at unknown dose, site or route of administration for an unknown indication (explicitly coded as 'incomplete course of vaccination'). Within five days of vaccination the patient was diagnosed with mpox. Nine (82 percent) were not on HIV treatment at mpox diagnosis. Median time from initial specimen collection to tecovirimat initiation was 5.5 days (range: 0-16, data available for 10 cases). Tecovirimat duration ranged from 21 to 120 days. Other medications co-administered with tecovirimat included vaccinia immune globulin (VIG) (n=9, 82 percent; brand name unknown), cidofovir (brand name unknown), brincidofovir (brand name unknown), and trifluridine eye drops (each with n=2, 18 percent; brand name unknown). Of cases receiving VIG, five (56 percent) received multiple doses. All 11 PWH were hospitalized with severe mpox manifestations. Examples included necrotic facial lesions, severe eye involvement and airway edema, and uncontrollable rectal bleeding.  As reported, as of 16-Dec-2022, one case (9 percent) had lesion resolution, five (45 percent) were still hospitalized on treatment, four (36 percent) died, and one (9 percent) had unknown clinical disposition. The group of PWH with advanced HIV had severe mpox manifestations and poor response to tecovirimat.  At the time of the initial report, the outcome of the event 'monkeypox' was unknown.  The reporter assessed the event 'monkeypox' as serious due to hospitalization but did not provide a causality assessment. Additionally, the event 'monkeypox' was assessed as serious due to the seriousness criteria of medical significance.  This case is linked with US-BN-2023-000893 and US-BN-2023-000894 concerning the same reporter.  Additional information received from Bavarian Nordic on 17-May-2023 included the local BN case ID.; Reporter's Comments: An adult patient of unknown gender (median age 38, between 29-45) received one dose of Jynneos vaccine, at unknown dose, site or route of administration for an unknown indication, which is considered as incomplete course of vaccination. Within five days of vaccination the patient was diagnosed with mpox (seriousness criteria: hospitalization and medical significance). Monkeypox is unlisted for Jynneos according to the CCDS and PI, whilst incomplete course of vaccination is considered as listed per company convention. The patient's current condition included HIV infection. Reportedly, the outcome of the event of monkeypox was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. The CCDS contains a warning that as with any other vaccine, vaccination may not result in protection in all cases. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An adult patient of unknown gender (median age 38, between 29-45) received one dose of Jynneos vaccine, at unknown dose, site or route of administration for an unknown indication, which is considered as incomplete course of vaccination. Within five days of vaccination the patient was diagnosed with mpox (seriousness criteria: hospitalization and medical significance). Monkeypox is unlisted for Jynneos according to the CCDS and PI, whilst incomplete course of vaccination is considered as listed per company convention. The patient's current condition included HIV infection. Reportedly, the outcome of the event of monkeypox was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. The CCDS contains a warning that as with any other vaccine, vaccination may not result in protection in all cases. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.