Sex: M
Vaccine: DTAP
Symptoms: Mental status changes, Migraine, Muscular weakness, Myelin oligodendrocyte glycoprotein antibody-associated disease, Paraesthesia
Clinical narrative: Myelin oligodendrocyte glycoprotein antibody-Associated Hemorrhagic acute disseminated encephalomyelitis; difficulty with walking and urination; Myelin oligodendrocyte glycoprotein antibody-Associated Hemorrhagic acute disseminated encephalomyelitis; retro-orbital headache; urinary retention; visual disturbance (blurred vision in the left eye); visual disturbance (blurred vision in the left eye); vertigo; subcortical white matter lesions in the posterior right frontal lobe; lymphocytic predominant pleocytosis; lower extremity weakness; cerebral venous sinus thrombosis; difficulty with walking and urination; lower extremity paresthesia; altered mental status; language disturbance; vasogenic edema; Initial information received on 17-Jul-2024 via other healthcare professional regarding an unsolicited valid serious case issued from a literature article:   This case involves a 35-year-old male patient who experienced myelin oligodendrocyte glycoprotein (MOG) antibody-associated hemorrhagic acute disseminated encephalomyelitis (ADEM) (Myelin oligodendrocyte glycoprotein antibody-associated disease) while receiving vaccine diphtheria, tetanus and acellular pertussis vaccine (Latency: 2 weeks).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date patient presented to an urgent care with 9 days of retro-orbital headache (headache). Two weeks before symptom onset, he received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination. He was diagnosed with migraine but returned to care 3 days later with persistent headache and new-onset urinary retention (urinary retention), visual disturbance (blurred vision in the left eye) (visual impairment) (vision blurred), and vertigo. MRI (magnetic resonance imaging) with contrast demonstrated an enhancing white matter T2/FLAIR (T2-weighted-Fluid-Attenuated Inversion Recovery) hyperintense lesion in the anterior right lateral aspect of the pons with additional subcortical white matter lesions in the posterior right frontal lobe (white matter lesion). There were anterior central T2 hyperintense lesions in the thoracic cord that enhanced with gadolinium. CSF (cerebro spinal fluid) analysis demonstrated a lymphocytic predominant pleocytosis (214 cells/uL) and elevated protein (61 mg/dL). He was treated with IV (intravenous) methylprednisolone (IVMP) 1,000 mg daily for 3 days and started intermittent bladder catheterization. Three days after IVMP, he returned to the emergency department with lower extremity weakness (Muscular weakness) and difficulty with walking and urination (Gait disturbance) (Dysuria). Despite additional IVMP followed by oral prednisone, his symptoms persisted, and he also developed lower extremity paresthesia (Paraesthesia).  At an outpatient neurology appointment 10 days later, his examination was notable for hyperreflexic patellar stretch and extensor plantar responses. He remained on prednisone 60 mg daily. Over the next few days, he developed worsened lower extremity weakness, altered mental status (Altered state of consciousness), and language disturbance (language disorder). He was hospitalized because of alertness and required intubation. Brain MRI with contrast demonstrated new multifocal T2/FLAIR hyperintensities in the supratentorial white matter, corpus callosum, and basal ganglia with peripheral enhancement and extensive intralesional blood products. Hemorrhagic T2/ FLAIR hyperintensities of the bilateral thalami were noted with evidence of thrombosis of the bilateral internal cerebral veins, straight sinus, transverse sinus, and right sigmoid sinus. No lesions were noted on the spinal MRI at this time. CSF analysis showed RBC (red blood cells) of 105 cells/ul, WBC (white blood cells) of 87 cells/ul (85% polys), and 89 mg/dL protein.  He was transferred to a tertiary care center for further management. Serum MOG-IgG (Ig- immunoglobulin) that had been drawn at his outpatient neurology appointment returned positive at a titer level of 1:1,000 by cell-based assay. CSF interleukin-6 (IL-6) level was elevated at 17,904.6 pg/mL (normal level =7.5 pg/mL). Given his worsening despite IV steroid treatment, he underwent 5 sessions of plasma exchange (PLEX), and the cerebral venous sinus thrombosis (CVST), presumed secondary to inflammation from MOGAD, was treated with anticoagulation. He improved clinically, and this was attributed to PLEX treatment. Interval imaging showed decreased enhancement and a marked decrease in vasogenic edema (Vasogenic cerebral oedema) surrounding numerous hemorrhagic lesions in the supratentorial brain. After his inpatient hospitalization, he was transferred to a rehabilitation hospital. Given the elevated CSF IL-6 level, he was started on the IL-6R antagonist tocilizumab 8 mg/kg every 4 weeks, which he has continued for more than one year. He completed a slow oral prednisone taper 10 months later. His serum MOG-IgG level remains positive at 1:1,000. Currently, he ambulates without assistance but struggles with neurocognitive deficits. He has not been able to return to work.  Seriousness criteria: Life threatening, medically significant and hospitalization for the event. Action taken: Not applicable. Corrective treatment: Anticoagulation, tocilizumab, methylprednisolone, bladder catheterization, intubation, prednisone, plasma exchange for the event. Outcome: Not recovered for the event. Reporter causality: Related.; Sender's Comments: Sanofi company comment dated 19-JUL-2024: This case involves a 35-year-old male patient who experienced MOG (myelin oligodendrocyte glycoprotein) antibody-associated hemorrhagic ADEM (acute disseminated encephalomyelitis) while receiving vaccine diphtheria, tetanus and acellular pertussis vaccine. 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, laboratory investigations 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.