Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Eye pain, Headache, Inflammation, Interleukin level increased, Leukocytosis
Clinical narrative: MOG antibody-associated hemorrhagic acute demyelinating encephalomyelitis (ADEM) with elevated CSF IL-6 after Tdap vaccination; retroorbital pain; headaches; new-onset urinary retention; vertigo; visual disturbance; neurological status deteriorated; cerebral sinus venous thrombosis secondary to inflammation due to MOGAD; Initial information received on 09-Oct-2024 from Health Care Professional regarding an unsolicited valid serious case issued from a literature article:    This case involves a 35-years-old male patient who experienced cerebral sinus venous thrombosis secondary to inflammation due to MOGAD (cerebral venous sinus thrombosis) (Latency: unknown) and MOG antibody-associated hemorrhagic acute demyelinating encephalomyelitis (ADEM) with elevated CSF IL-6 after Tdap vaccination (myelin oligodendrocyte glycoprotein antibody-associated disease) (Diphtheria, Tetanus and acellular pertussis vaccine) (latency: 14 days).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, patient had received a dose of (Tdap) Diphtheria, Tetanus and acellular pertussis vaccination produced by unknown manufacturer lot number not reported via unknown route in unknown administration site 14 days prior, presented to urgent care with headaches (headache) and retroorbital pain (eye pain). Initially diagnosed with migraines and prescribed medication, he returned three days later with persistent symptoms, including new-onset urinary retention (urinary retention), visual disturbance (visual impairment), and vertigo. Magnetic resonance imaging (MRI) revealed specific lesions, and initial Cerebrospinal fluid (CSF) analysis indicated elevated protein and leukocytosis without oligoclonal bands. Treatment with intravenous (IV) methylprednisolone (MP) was followed by a discharge, but symptoms worsened, requiring additional IVMP and oral prednisone. As his neurological status deteriorated (condition aggravated), he was intubated and transferred to a tertiary care center for further management.  Results: Repeat MRI showed multifocal T2 hyperintensities, associated hemorrhage, thrombosis of internal cerebral veins and venous sinuses. CSF showed white blood cells (WBCs) of 87 cells/l (85% polys), 89 mg/dl protein. MOG (myelin oligodendrocyte glycoprotein - immunoglobulin G (IgG) by (cell-based assay) CBA returned positive with a titer level of 1:1000, and CSF interleukin-6 (IL-6) was 17,904.6 pg/ml. As the patient did not respond to IV steroids, he underwent plasma exchange, and improved. The cerebral sinus venous thrombosis was presumed secondary to inflammation due to MOGAD. To prevent further relapses, he was started on tocilizumab. He has not experienced relapses and has sustained to improvement.   Author stated that: It has been documented that infections can trigger myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). This case showcases a remarkable instance of MOG IgG-associated hemorrhagic ADEM with significantly elevated CSF IL-6 following Tdap vaccination. The association of Tdap vaccination with ADEM and TM prompts consideration of its role in precipitating this patient's condition. Emphasizing the importance of testing CSF cytokines, including IL-6, in new onset MOGAD, our findings endorse the use of anti-IL-6R monoclonal antibody therapy in MOGAD.  Seriousness criteria: medically significant for both events. Action taken: not applicable. Corrective treatment: methylprednisolone and prednisone, intubated and plasma exchange for MOG antibody-associated hemorrhagic acute demyelinating encephalomyelitis (ADEM) with elevated CSF IL-6 after Tdap vaccination. For cerebral sinus venous thrombosis not reported. Outcome: Recovered / Resolved for the event mog antibody-associated hemorrhagic acute demyelinating encephalomyelitis (adem) with elevated csf il-6 after tdap vaccination and Unknown for the event cerebral sinus venous thrombosis secondary to inflammation due to mogad. Reporter's causality: Related; Sender's Comments: Sanofi company comment on dated 15-OCT-2024: This case involves a 35-years-old male patient who experienced cerebral sinus venous thrombosis secondary to inflammation due to MOGAD (cerebral venous sinus thrombosis) (Latency: unknown) and MOG antibody-associated hemorrhagic acute demyelinating encephalomyelitis (ADEM) with elevated CSF IL-6 after Tdap vaccination (myelin oligodendrocyte glycoprotein antibody-associated disease) (Diphtheria, Tetanus and acellular pertussis vaccine) (latency: 14 days). Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely.