Sex: M
Vaccine: SMALLMNK
Symptoms: Cytology abnormal, Dehydration, Diarrhoea, Fatigue, Genital lesion
Clinical narrative: Monkeypox infection; Syphilis reinfection; COVID-19;   Case reference number US-BN-2024-000098 is a spontaneous literature case report identified on 23-Jan-2024, and concerns a 37-year-old male patient.  The article aimed to present the cytology findings of samples taken from swabs of mucocutaneous monkeypox (mpox) lesions in three different patients.  For the patient, sample was received in 15-mL tubes containing 3 cc ThinPrep PreservCyt Solution. The tubes were spun down for six minutes at 1600g to consolidate the material. The supernatant was poured off and the concentrated material was pipetted into a cytofunnel chamber along with a drop (0.5 mL) of Cytospin Collection Fluid (Fisher Scientific). The chambers holding Superfrost Plus microscope slides (Fisher Scientific) were centrifuged at 1000 rpm for 5 minutes. Slides were removed from the slots and placed directly into 95 percent alcohol for fixation. Slides were then stained using the Papanicolaou (Pap) method (EA- 50, Papanicolaou, and hematoxylin, Ricca Chemical). For each case, key features were noted, including cytoplasmic features, nuclear features, and background. Relevant clinical and laboratory data were collected from the electronic medical chart.  On an unknown date, the patient received the first dose of Jynneos (batch number: unknown), at an unknown dose, route, or site of administration, for an unknown indication. The patient had a medical history of human immunodeficiency virus (HIV) / acquired immunodeficiency syndrome (AIDS), (CD4 count 63 cells/mm3; viral load 230,000 copies/mL), syphilis, and chronic hepatitis C and presented to the emergency department with a three-week history of fatigue, painful skin lesions, a penile ulcer, and recent diarrhea.  On an unspecified date, the patient received the second dose of Jynneos (batch number: unknown), as reported, one day prior to symptom onset, at an unknown dose, route, or site of administration. The patient was admitted to an outside hospital two weeks prior for similar symptoms and was diagnosed with monkeypox infection (West African clade) by DNA Polymerase chain reaction (PCR), HIV (HIV antibody detected through enzyme-linked immunoassay), COVID-19 (PCR), and syphilis reinfection (rapid plasma reagin titer 1:128) concurrently. The patient did not receive antiviral therapy and was readmitted to the facility with progressive ulcerated, pustular, and umbilicated lesions noted on the oral mucosa, face, scalp, bilateral ears, extremities, trunk, and penis, and the patient's scrotum was diffusely swollen. The patient was admitted to the hospital with progressive mpox, cellulitis of the penis/scrotum, COVID-19, dehydration, and hyponatremia. The patient's cytology findings demonstrated squamous cells with enlarged nuclei, open chromatin, and prominent red nucleoli, occasional scattered cells showed intracytoplasmic structures suggestive of Guarnieri bodies (GBs). The specimen demonstrated a necrotic and inflammatory background. The residual keratinocytes showed marked atypia in the form of enlarged irregular nuclei with relatively open chromatin and prominent red nucleoli. There were no multinucleated keratinocytes. Rare cells showed intracytoplasmic structures suggestive of GBs vs prominent keratohyalin granules. The cytopathic changes of monkeypox were not specific, but their recognition could prompt appropriate PCR testing.  At the time of the initial report, the outcome of the events of monkeypox infection, COVID-19, and syphilis reinfection was unknown.  The reporter assessed the events of monkeypox infection, COVID-19, and syphilis reinfection as serious due to hospitalization, additionally, the events of monkeypox infection and syphilis reinfection were assessed as serious due to criteria of medical significance. The reporter did not provide a causality assessment for the events of monkeypox infection, COVID-19, and syphilis reinfection.  The case is linked with US-BN-2024-000097, concerning the same article.  No further information was provided.; Reporter's Comments: A 37-year-old male patient developed serious events of monkeypox, syphilis and COVID-19 (hospitalization and medical significance) on an unspecified date, an unknown amount of time after the patient received the second dose of Jynneos for an unknown indication. The events are unlisted and unexpected for Jynneos according to the CCDS v6 and PI. 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. Also, considering the nature of the events, syphilis and COVID-19 have been considered as not related to the suspect vaccine. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: A 37-year-old male patient developed serious events of monkeypox, syphilis and COVID-19 (hospitalization and medical significance) on an unspecified date, an unknown amount of time after the patient received the second dose of Jynneos for an unknown indication. The events are unlisted and unexpected for Jynneos according to the CCDS v6 and PI. 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. Also, considering the nature of the events, syphilis and COVID-19 have been considered as not related to the suspect vaccine. This case is considered as serious due to hospitalization and medical significance.