Sex: M
Vaccine: SMALLMNK
Symptoms: Pyrexia, Skin lesion, Syncope
Clinical narrative: Monkeypox virus; Syncopal episode; Literature citation:   Case reference number US-BN-2024-000097 is a spontaneous literature case report, title as stated above, identified on 23-Jan-2024, and concerns a 55-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, the sample was collected in the Aptima preservative transport media. 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. 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, as reported ten days before presentation, 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 the human immunodeficiency virus (HIV) (CD4 count 441 cells/mm3; viral load 36 copies/mL), cutaneous T-cell lymphoma, perirectal human papillomavirus, genital herpes simplex virus (HSV), syphilis, hyperlipidemia, asthma, glucose-6-phosphate dehydrogenase deficiency, and stage 3a chronic kidney disease who presented to our outpatient clinic with a one - to two-day history of lesions on the chest, back, and face following three days of subjective fever and fatigue and a syncopal episode two days prior to presentation. Vesicular lesions were observed on the chest, back, face, and oral mucosa, and real-time PCR testing of the chest lesions was positive for monkeypox virus and negative for HSV 1 and HSV 2. Additional tests for chlamydia and gonorrhea from mucosal swabs (amplified nucleic acid probe assay for detection of ribosomal RNA) were negative. The patient's last sexual encounter was approximately one month prior to presentation and was protected. The specimen demonstrated predominantly anucleate keratinocytes in a clean background, but occasional viable cells demonstrated nuclear atypia in the form of enlarged round nuclei with glassy open chromatin and occasional prominent red nucleoli. Rare multinucleated keratinocytes were present. No definite Guarnieri bodies (GBs) were identified.  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 virus and syncopal episode was unknown.  The reporter did not provide a seriousness and causality assessment for the events of monkeypox virus and syncopal episode, additionally, the events of monkeypox virus and syncopal episode were assessed as serious due to criteria of medical significance.   The case is linked with US-BN-2024-000098, concerning the same article.  No further information was provided.; Reporter's Comments: A 55-year-old male patient experienced serious events of monkeypox and syncope (medical significance) an unknown amount of time after the patient received the first dose of Jynneos for an unknown indication. Anxiety-related reactions, including vasovagal reactions, such as syncope is listed for Jynneos according to the CCDS v6 and unexpected per USPI, whilst monkeypox is unlisted and unexpected. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the event of syncope has been considered as related to Jynneos. 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.; Sender's Comments: A 55-year-old male patient experienced serious events of monkeypox and syncope (medical significance) an unknown amount of time after the patient received the first dose of Jynneos for an unknown indication. Anxiety-related reactions, including vasovagal reactions, such as syncope is listed for Jynneos according to the CCDS v6 and unexpected per USPI, whilst monkeypox is unlisted and unexpected. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the event of syncope has been considered as related to Jynneos. 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.