Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | — |
clade II mpox with a genital rash; Literature citation. Case reference number US-BN-2026-000442 is a spontaneous literature case report, title as stated above, identified on 08-Jul-2025, and concerns a male patient of unknown age (patient five). During the global clade II mpox outbreak, cases had disproportionately affected gay, bisexual, and other men who had sex with men (MSM). Cruise ship travel-associated mpox infections have not been previously described. During January 25-April 18, 2024, CDC was notified of eight mpox cases among cruise travelers on four ships: four among crew members and four among passengers. Seven cases were laboratory-confirmed as clade II Monkeypox virus. All exposure histories indicated male-to-male sexual contact. No patients were hospitalized, and none died. Crew members with mpox received their diagnoses on board and were isolated while infectious. Contacts were identified, monitored, and assessed for mpox postexposure prophylaxis (mpox vaccination). No crew members with mpox had been vaccinated against mpox. Passengers with mpox received their diagnoses after cruising on voyages marketed to gay and bisexual men, with symptom onset dates suggesting voyage exposures. For one cruise ship, two of the three reports of mpox among passengers were received after health departments were notified of potential cruise-associated exposures, and letters were sent to other passengers. Three of the four passengers with mpox had received two doses of JYNNEOS vaccine in 2022. Cruise lines should consider educating crew members on symptoms, risks, and preventive measures related to mpox and working with medical personnel to facilitate mpox vaccination as preexposure prophylaxis for eligible crew members. Cruise passengers who were eligible, predominantly MSM, should receive mpox vaccine before cruise travel. For cruise voyages marketed to gay and bisexual men, having mpox vaccine available on board would facilitate timely postexposure prophylaxis, if indicated; mpox prevention messaging and education before and during a voyage are also recommended. The patient's medical history and concomitant medication details were not provided. On an unspecified date in 2022, the patient received the first dose of Jynneos vaccine (brand name: unknown), at an unknown dose, route, and site of administration for pre-exposure prophylaxis. On an unspecified date in 2022, the patient received the second dose of Jynneos vaccine (brand name: unknown), at an unknown dose, route, and site of administration. As reported, the patient had 25 and four sexual partners during the voyage. On an unspecified date, on the day of disembarkation, the patient experience genital rash. On an unspecified date, the patient's laboratory test showed results as follows: Polymerase chain reaction (PCR) confirmed clade II mpox. At the time of initial report, it was unknown if the patient recovered from the event of 'mpox'. The reporter did not provide a seriousness assessment for the event of 'mpox'; however, the event was assessed as serious due to the seriousness criteria of medical significance. The reporter did not provide a causality assessment for the event of 'mpox'. The case is linked with the cases ID US-BN-2026-000441 and ID US-BN-2026-000443 (the same article). No further information provided.; Reporter's Comments: A male patient of unknown age received two doses of Jynneos vaccine for pre-exposure prophylaxis. On an unspecified date, the patient had multiple sexual partners during the voyage. Reportedly, the patient experienced a serious event of monkeypox (medical significance). Monkeypox is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A male patient of unknown age received two doses of Jynneos vaccine for pre-exposure prophylaxis. On an unspecified date, the patient had multiple sexual partners during the voyage. Reportedly, the patient experienced a serious event of monkeypox (medical significance). Monkeypox is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.
Comments: None.
Test Name: PCR; Result Unstructured Data: Test Result:/ ;confirmed clade II mpox; Comments: /