Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
diarrhea, asymmetric arthritis, dysuria, and uveitis due to reactive arthritis; Literature citation. Case reference number US-BN-2025-001627 is a spontaneous literature case report, title as stated above, identified on 02-Oct-2025, and concerns a 51-years-old male patient. The patient's medical history includes asthma. The patient's family history was remarkable for premature coronary artery disease in patient's father. The patient's past procedure included right rotator cuff tear status post right arthroscopic rotator cuff repair. The patient's current condition included Human Immunodeficiency Virus (HIV) . The patient's concomitant included HIV medications, gabapentin, emtricitabine/tenofovir, dolu-tegravir (brand names: unknown) and albuterol inhaler (salbutamol) On an unspecified date, the patient received the Jynneos (batch number: unknown), at an unknown dose, route or site of administration, for the indication prevention from mpox. On an unspecified date, two hours after vaccination with Jynneos, fever for two weeks with associated rigors, despite taking treatment of acetaminophen every four h. On an unspecified date, reported as two days later, the patient experienced severe watery diarrhea which lasted for about a week. On an unspecified date, the patient had treatment with bismuth subsalicylate for diarrhea and ibuprofen for fever. Patient denied nausea, vomiting, mucocutaneous rash, increased urinary frequency/urgency, recent travel, or sick contact. On an unspecified date the patient have a fever of 100.9° Fahrenheit and sinus tachycardia (110-120 beats per minute) with normal respiratory rate and oxygen saturation. Physical examination was unremarkable except for slight tenderness in the right shoulder joint at the site of the previous arthroscopy. On unspecified date, the patient's laboratory examination included no leukocytosis, elevated acute phase reactants C-reactive protein was67.82 mg/L (reference range: 0-10 mg/L); erythrocyte sedimentation rate was 38 mm/h (reference range: 0-30 mm/h). Patient's HIV viral load was undetectable with normal absolute CD4 count was673 cells/U (reference range: 404-1612 cells/UL). Blood, urine, and stool studies for infectious pathogens were negative. Cytomegalovirus PCR, respiratory viral panel, and tests for sexually transmitted infections, including nucleic acid amplification testing for chlamydia/gonorrhea, were negative. Chest X-ray was unremarkable. Patient's electrocardiogram showed sinus tachycardia with ventricular rate of 110 beats per minute, and echocardiogram showed left ventricular function of 60%-65% with no obvious valvular vegetation or pericardial effusion. Troponin T 5th-generation test was negative. A seven-day cardiac monitor showed sinus rhythm with average rate of 104 beats per minute. On an unspecified date, the patient's Left knee synovial fluid analysis showed Clarity was transparent (normal range: transparent); color was clear (normal range: clear), viscosity was low ( normal range: high), , white blood cells (WBC) was 1751 / mm3 (normal range: less 200), polymorphonuclear (PMN) leucocyte cells was 30% (normal range: less 25), glucose 119 mg/dL (normal range: 70-110), Protein was 5.3 gm/dL (normal range: 15-2.5) and crystal was negative (normal range: negative) On an unspecified date, the patient was under evaluation for tachycardia and fever, but patient started having progressively worsening pain and swelling of the left knee and ankle joint, restricting mobility. On examination, patient's left knee was red, swollen, and warm with positive tenderness in the left medial knee and 1+ pitting edema extending from the left foot to the knee. A complete duplex ultrasound of the left lower extremity was negative for deep vein thrombosis. MRI left knee without contrast showed grade 2 tear to the origin of the medial collateral ligament with some underlying medial femoral condyle edema and knee effusion. Patient underwent aspiration of the left knee effusion, yielding 50 cc of clear fluid with slightly elevated white blood cell count and protein level suggestive of inflammatory arthritis. Antinuclear antibody, rheumatoid factors, and HLAB27 were negative. Joint fluid crystals, cultures, and Lyme PCR testing were negative (normal range: negative). . The patient subsequently developed migratory arthritis (left elbow, right knee, bilateral temporomandibular joints) and redness in the left eye with floater spots and decreased vision. On an unspecified date, eye examination showed normal fundus with reduced visual acuity, circum-corneal congestion, keratin precipitate, irregular pupil, and anterior chamber cells suggestive of anterior uveitis. Visual acuity (Snellen-linear): right eye was 20/20 and left eye was 20/50 (normal range: 20/20), tonometry: right eye was 15 mmHg and left eye was 10 mmHg (normal range: 1021 mmHg),pupil reaction: right eye was brisk and left eye was sluggish (normal: brisk), pupil shape: right eye was round and left eye was irregular (normal: round), lids/lashes: both eyes were normal, conjunctiva/sclera: right eye was white and quiet; left eye showed 1+ injection 360° (normal: white and quiet), cornea: right eye was clear; left eye showed mild Descemet's folds without NaFl staining (normal: clear), anterior chamber: right eye was deep and quiet with no cells; left eye showed 2+ cells without hypopyon (normal: deep and quiet, no cells), iris: right eye was normal; left eye showed scattered posterior synechiae (normal: normal), lens: right eye was clear; left eye showed scattered pigment on the anterior capsule (normal: clear), vitreous: right eye was normal; left eye showed 1+ vitreous cells (normal: clear). On an unspecified date, the patient was started with treatment of prednisone eye drops every one hour and cyclopentolate twice a day. It was considered unlikely that extensive left knee swelling with effusion and pitting edema distally was associated with the small meniscal tear. The patient's diarrhea, asymmetric arthritis, dysuria, and uveitis were believed to be due to reactive arthritis. After septic arthritis was ruled out, the patient was started on methylprednisolone for two weeks. Patient's arthralgia improved when the patient was taking methylprednisolone, but it returned after finishing the course. On an unspecified date, patient started treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) three times daily with minimal benefit. Given the diminished visual field and migratory arthritis unresponsive to NSAIDs, patient was re-started on prednisone 20 mg daily for one week followed by 10 mg daily with meloxicam 15 mg daily. One month after treatment with steroids and NSAIDs, patient's arthralgia was well controlled and acute phase reactants returned to baseline. The patients visual field defect persisted. At the time of initial report, it was unknown if the patient recovered from event of 'reactive arthritis'. The reporter did not provide a seriousness and causality assessment for the event of 'reactive arthritis', however, the event of reactive arthritis was assessed as serious due to the seriousness criteria of medical significance. No further information was provided.; Reporter's Comments: This case concerns a 51-years-old male patient, who experienced serious (medically significant) event of reactive arthritis, on unspecified date after the patient receiving the first dose of Jynneos vaccine for the indication prevention from Mpox. Reactive arthritis is unlisted as per CCDS v7 and unexpected per USPI. Patient's medical history includes asthma and concomitant medication details were not provided. Outcome is unknown. For regulatory reporting purposes, causality is assessed as possibly related to the suspect. This case is considered as serious due to medical significance criteria.; Sender's Comments: This case concerns a 51-years-old male patient, who experienced serious (medically significant) event of reactive arthritis, on unspecified date after the patient receiving the first dose of Jynneos vaccine for the indication prevention from Mpox. Reactive arthritis is unlisted as per CCDS v7 and unexpected per USPI. Patient's medical history includes asthma and concomitant medication details were not provided. Outcome is unknown. For regulatory reporting purposes, causality is assessed as possibly related to the suspect. This case is considered as serious due to medical significance criteria.
Medical History/Concurrent Conditions: Arthroscopic surgery; Asthma; HIV disease
GABAPENTIN; EMTRICITABINE;TENOFOVIR; DOLUTEGRAVIR; ALBUTEROL [SALBUTAMOL]
Test Name: Antinuclear antibody; Result Unstructured Data: negative; Test Name: left knee synovial fluid analysis; Test Result: 119 mg/dL; Test Name: Blood, urine, and stool studies for infectious pathogens; Result Unstructured Data: studies for infectious pathogens were negative; Test Name: Temperature; Result Unstructured Data: 100.9 Fahrenheit; Test Name: 7 day cardiac monitor; Result Unstructured Data: showed sinus rhythm with average rate of 104 beats per minute; Test Name: CD4; Test Name: C-reactive protein; Test Name: cultures; Result Unstructured Data: negative; Test Name: echocardiogram; Result Unstructured Data: echocardiogram showed left ventricular function of 60%-65% with no obvious valvular vegetation or pericardial effusion; Test Name: electrocardiogram; Result Unstructured Data: showed sinus tachycardia with ventricular rate of 110 beats per minute; Test Name: Heart rate; Result Unstructured Data: 110-120 heart beats per minute; Test Name: HLAB27; Result Unstructured Data: negative; Test Name: Eye examination; Result Unstructured Data: Right eye 15 millimetre of mercury Lef eye 10 millimetre of mercury; Test Name: Joint fluid crystals; Result Unstructured Data: negative; Test Name: left knee synovial fluid analysis; Result Unstructured Data: 30 %; Test Name: MRI left knee without contrast; Result Unstructured Data: showed grade 2 tear to the origin of the medial collateral ligament with some underlying medial femoral condyle edema and knee effusion; Test Name: nucleic acid amplification testing for chlamydia/gonorrhea; Result Unstructured Data: negative; Test Name: Eye examination; Result Unstructured Data: showed normal fundus with reduced visual acuity, circum-corneal congestion, keratin precipitate, irregular pupil, and anterior chamber cells suggestive of anterior uveitis Pupil shape: right eye - round, left eye - irregular Lids / Lashes: right eye - normal, left eye - normal Conjunctiva/Sclera: right eye - White and quiet, left eye - 1+ injection 360 Cornea: right eye - clear, left eye - Mild desc folds, no NaF1 staining Anterior chamber: right eye - Deep and quiet, no cell, lef eye - 2+cell, no hypopyon Iris: right eye - normal, lef eye - Scattered posterior synechiae Lens: right eye - normal, lef eye - Scattered pigment on anterior capsule Vitreous: right eye - normal, lef eye- 1+ vitreous cells; Test Name: oxygen saturation; Result Unstructured Data: normal; Test Name: Physical examination; Result Unstructured Data: unremarkable except for slight tenderness in the right shoulder joint at the site of the previous arthroscopv; Test Name: Cytomegalovirus PCR; Result Unstructured Data: Negative; Test Name: Lyme PCR testing; Result Unstructured Data: negative; Test Name: left knee synovial fluid analysis; Test Name: Eye examination; Result Unstructured Data: Right eye: brisk Left eye: sluggish; Test Name: erythrocyte sedimentation rate; Test Name: Respiratory rate; Result Unstructured Data: normal; Test Name: respiratory viral panel; Result Unstructured Data: negative; Test Name: rheumatoid factors; Result Unstructured Data: negative; Test Name: tests for sexually transmitted infections; Result Unstructured Data: negative; Test Name: Blood, urine, and stool studies for infectious pathogens; Result Unstructured Data: studies for infectious pathogens were negative; Test Name: Left knee synovial fluid analysis; Result Unstructured Data: Clarity - Transparent Color - Clear Viscosity - Low; Test Name: Troponin T 5th-generation test; Result Unstructured Data: negative; Test Name: complete duplex ultrasound of the left lower extremity; Result Unstructured Data: negative for deep vein thrombosis; Test Name: Blood, urine, and stool studies for infectious pathogens; Result Unstructured Data: studies for infectious pathogens were negative; Test Name: laboratory diagnosis; Result Unstructured Data: no leuko- cytosis, elevated acute phase reactants; Test Name: Eye examination; Result Unstructured Data: Right eye: 20/20 Left eye 20/50; Test Name: left knee synovial fluid analysis; Result Unstructured Data: Test Result:1751 /mm3;Test low range:/ /mm3;Test high range:<200 /mm3;