Sex: M
Vaccine: SMALLMNK
Symptoms: Monkeypox, Neisseria test negative, Off label use, Oral disorder, Orthopoxvirus test positive
Clinical narrative: The patient received second dose of Jynneos after presenting monkeypox symptoms; Urine culture revealed pseudomonas aeruginosa and klebsiella pneumoniae; Urine culture revealed pseudomonas aeruginosa and klebsiella pneumoniae; Monkeypox; Presumed late latent syphilis; Scrotal and penile cellulitis secondary to MRSA; Hepatitis C RNA PCR viral load 10,000 IU/mL; Hepatitis A IgM positive; Tested positive for COVID-19, asymptomatic;  Case reference number US-BN-2023-001797 is a literature case report, identified on 14-Nov-2023, and concerns a 37-year-old male patient.  The aim of article was to describe the concurrent infection of monkeypox in the setting of severe immunodeficiency (AIDS), late latent syphilis, and scrotal and penile cellulitis secondary to (methicillin-resistant staphylococcus aureus) MRSA.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: not provided), at an unknown dose, route or site of administration, for an unknown indication.  On unspecified date, unknown amount of time after receiving the first dose of Jynneos, the patient presented to an outside hospital emergency department for ulcerations and lesions on the penis and scrotum. A qualitative polymerase chain reaction (PCR) of the swabbed lesions revealed monkeypox. The patient received second dose of Jynneos (batch number: not provided) unknown amount of time after receiving the first dose, at an unknown dose, route or site of administration (explicitly coded as 'off label vaccine use') and was discharged home with amoxicillin clavulanate and mupirocin ointment (brand name unknown).   On unspecified date, reported as four days later, the patient presented again to the same emergency department with a diffuse rash on the nose, back, face, chest, and arms and induration with multiple ulcerations on the penis. A rapid plasma reagent (RPR) returned with 1:128 titer, and fluorescent treponemal antibody absorption test (FTA-ABS) was positive. The patient received 2.4 MU of penicillin (brand name unknown) for presumed late latent syphilis, given history of primary syphilis treated in 2014. As reported, CD4 count was 129 cells/mm3, and the patient received sulfamethoxazole/trimethoprim for pneumocystis pneumonia (PCP) prophylaxis. The patient was prescribed with highly active antiretroviral therapy (HAART) and sulfamethoxazole/trimethoprim (brand name unknown). The patient also tested positive for COVID 19 but remained asymptomatic. As reported, the patient then left against medical advice from the hospital for unclear reasons.  On unspecified date, reported as three weeks later, the patient presented to emergency department with a complaint of fatigue. As reported, the patient did not comply with antibiotic regimen or HAART and expressed discomfort from whole body and oral lesions. After discussion with infectious disease specialists, it was considered beneficial to initiate antiviral treatment for monkeypox lesions given a prolonged course of symptoms in the setting of immunodeficiency. The patient was started on Tpoxx (tecovirimat) for 28 doses. CD4 count returned at 63 cells/mm3, and HIV viral load was over 230,000 copies per microliter. PCP prophylaxis and HAART were initiated. Hepatitis A IgM was positive, and Hepatitis C RNA PCR viral load was 10 000 IU/mL. RPR was reactive at 1:64 titer. The patient was treated for late latent syphilis and given two doses of Bicillin (benzathine benzylpenicillin) 2.4 million units each 1 week apart for three doses. Patient also had significant scrotal edema with superficial overlying gangrenous changes. Empiric antibiotics (vancomycin, ceftriaxone, and metronidazole (brand name unknown)) were stopped after 13 days when blood cultures remained negative. Urine screening for gonorrhea and chlamydia was negative, however urine culture revealed 50 000 to 99 000 colony-forming unit (CFU) per millilitre Pseudomonas aeruginosa and 10 000 to 49 000 CFU per millilitre Klebsiella pneumoniae and was discharged home with levofloxacin and doxycycline (brand name unknown) for 10 days after improvement of symptoms. After one month of HAART, the patient was advised to follow up with urology outpatient for surgical debridement due to the high risk of infections in immunocompromised state. It was reported that the patient had multiple infections (monkeypox, cellulitis, syphilis, hepatitis C, COVID 19) due to severe immunodeficiency. Clinically, there was difficulty discerning whether this patient's whole body and facial lesions were from monkeypox alone or gummas from tertiary syphilis due to similarities in gross appearance.  At the time of initial report, the outcome for the events of monkeypox, 'hepatitis C RNA positive', 'asymptomatic COVID-19', late syphilis latent, 'hepatitis A virus IgM antibody positive', 'MRSA cellulitis', 'klebsiella pneumoniae test positive' and 'pseudomonas aeruginosa test positive' was unknown.  The reporter did not provide the seriousness assessment for the events of monkeypox, 'hepatitis C RNA positive', 'asymptomatic COVID-19', late syphilis latent, 'hepatitis A virus IgM antibody positive', 'MRSA cellulitis', 'klebsiella pneumoniae test positive' and 'pseudomonas aeruginosa test positive'. However, the events of monkeypox, 'hepatitis C RNA positive', late syphilis latent, 'MRSA cellulitis', 'klebsiella pneumoniae test positive' and 'pseudomonas aeruginosa test positive' were assessed as serious due to criteria of medical significance. The reporter did not provide the causality assessment for the events of 'hepatitis A virus IgM antibody positive', 'klebsiella pneumoniae test positive' and 'pseudomonas aeruginosa test positive', while the events of monkeypox, 'hepatitis C RNA positive', 'asymptomatic COVID-19', 'MRSA cellulitis' and late syphilis latent were assessed as not related due to severe immunodeficiency.  No further information was provided.; Reporter's Comments: A 37-year-old male patient was vaccinated with a dose of Jynneos via unknown route of administration. An unknown amount of time later, the patient developed penile and scrotal lesions and ulcerations. Swab PCR confirmed mpox infection. A second dose of Jynneos was given (which is considered off label vaccine use). The patient was prescribed with antibiotics. Four days later, the patient returned to the ED with a diffuse rash, as well as induration of the penile lesions. Due to positive RPR and FTA-ABS, this was assumed to be a latent syphilis, based on the patient's past history of syphilis. The patient was prescribed HAART and sulfamethoxazole/trimethoprim. The patient was also tested for COVID-19 but was asymptomatic. Three weeks later, the patient returned again to the ED, with complaints of fatigue. Patient had poor compliance to the prescribed therapeutical regimen and there were whole body discomfort and oral lesions. HIV viral load was 230k copies/mL. Hepatitis IgM was positive, hepatitis C RNA  PCR viral load was 10000 IU/mL. Urine culture was negative for gonorrhoea and chlamydia, but were positive for the presence of K. pneumoniae and P. aeruginosa. Patient also developed penile MRSA cellulitis. The events of mpox, K. pneumoniae test positive, P. aeruginosa test positive, latent syphilis, MRSA cellulitis, hepatitis C RNA positive, hepatitis A IgM positive and COVID-19 are unlisted and unlabeled per the Regulatory Authority and prescribing information for Jynneos. Off label use is considered listed per company conventions. Medical history included AIDS (due to untreated HIV) and past syphilis. Noted that the patient was given a second dose of Jynneos after lesions had already been developed. Based on the fact that Jynneos is a non-replicating vaccine which does not contain the mpox virus, the event of mpox is assessed as not related to Jynneos. Latent syphilis is considered not related to Jynneos, but to reactivation of the primary infection from the past, contributed to by immunodeficiency and incompliance to antiretroviral therapy. The co-infection with the opportunistic Klebsiella and Pseudomonas (although without specific symptoms mentioned), as well as the subsequent MRSA development on cellulitis can be explained by the severe immunodeficiency; and they are unrelated to Jynneos due to lack of biological plausibility. No associated symptoms were reported (such as jaundice for the hepatitis), and due to the known routes of transmission, the events of COVID-19, positive hepatitis A and C tests are also considered not related to Jynneos. The patient developed mpox system an unknown amount of time after the first dose, which is insufficient for immunity, especially in the setting of AIDS. The incompliance to therapeutical prescriptions and recommendations resulted in the following complications of cellulitis and reactivation of latent syphilis. Off label use is not related to Jynneos, but to human factors. The case is serious due to medical significance of mpox, Klebsiella, Pseudomonas, hepatitis C RNA positive, syphilis, cellulitis.; Sender's Comments: A 37-year-old male patient was vaccinated with a dose of Jynneos via unknown route of administration. An unknown amount of time later, the patient developed penile and scrotal lesions and ulcerations. Swab PCR confirmed mpox infection. A second dose of Jynneos was given (which is considered off label vaccine use). The patient was prescribed with antibiotics. Four days later, the patient returned to the ED with a diffuse rash, as well as induration of the penile lesions. Due to positive RPR and FTA-ABS, this was assumed to be a latent syphilis, based on the patient's past history of syphilis. The patient was prescribed HAART and sulfamethoxazole/trimethoprim. The patient was also tested for COVID-19 but was asymptomatic. Three weeks later, the patient returned again to the ED, with complaints of fatigue. Patient had poor compliance to the prescribed therapeutical regimen and there were whole body discomfort and oral lesions. HIV viral load was 230k copies/mL. Hepatitis IgM was positive, hepatitis C RNA  PCR viral load was 10000 IU/mL. Urine culture was negative for gonorrhoea and chlamydia, but were positive for the presence of K. pneumoniae and P. aeruginosa. Patient also developed penile MRSA cellulitis. The events of mpox, K. pneumoniae test positive, P. aeruginosa test positive, latent syphilis, MRSA cellulitis, hepatitis C RNA positive, hepatitis A IgM positive and COVID-19 are unlisted and unlabeled per the Regulatory Authority and prescribing information for Jynneos. Off label use is considered listed per company conventions. Medical history included AIDS (due to untreated HIV) and past syphilis. Noted that the patient was given a second dose of Jynneos after lesions had already been developed. Based on the fact that Jynneos is a non-replicating vaccine which does not contain the mpox virus, the event of mpox is assessed as not related to Jynneos. Latent syphilis is considered not related to Jynneos, but to reactivation of the primary infection from the past, contributed to by immunodeficiency and incompliance to antiretroviral therapy. The co-infection with the opportunistic Klebsiella and Pseudomonas (although without specific symptoms mentioned), as well as the subsequent MRSA development on cellulitis can be explained by the severe immunodeficiency; and they are unrelated to Jynneos due to lack of biological plausibility. No associated symptoms were reported (such as jaundice for the hepatitis), and due to the known routes of transmission, the events of COVID-19, positive hepatitis A and C tests are also considered not related to Jynneos. The patient developed mpox system an unknown amount of time after the first dose, which is insufficient for immunity, especially in the setting of AIDS. The incompliance to therapeutical prescriptions and recommendations resulted in the following complications of cellulitis and reactivation of latent syphilis. Off label use is not related to Jynneos, but to human factors. The case is serious due to medical significance of mpox, Klebsiella, Pseudomonas, hepatitis C RNA positive, syphilis, cellulitis.