Sex: M
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme, Anti-aquaporin-4 antibody, Antibody test, Antinuclear antibody, Babinski reflex test
Clinical narrative: Longitudinally Extensive Transverse Myelitis; This is a literature report for the following literature source(s).  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 infection" (not ongoing), notes: 10 months earlier with complete recovery without treatment. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 immunization. The following information was reported: MYELITIS TRANSVERSE (hospitalization, medically significant), 20 days after the suspect product(s) administration, outcome "recovered", described as "Longitudinally Extensive Transverse Myelitis". The event "longitudinally extensive transverse myelitis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiotensin converting enzyme: unremarkable; Anti-aquaporin-4 antibody: unremarkable; Antibody test: unremarkable; Unremarkable; Antinuclear antibody: unremarkable; unremarkable; Babinski reflex test: positive; Blood copper: unremarkable; Blood immunoglobulin G: unremarkable; Blood immunoglobulin M: unremarkable; Blood pressure measurement: 136/72 mmHg; Body temperature: 36.7 Centigrade; CSF glucose (55-88): 59 mg/dl; CSF lymphocyte count (40-80): 12 %; CSF monocyte count (15-45): 71 %; CSF neutrophil count (0-6): 17 %; CSF oligoclonal band (0-1): 0, notes: bands; CSF protein (15-45): 68 mg/dl; CSF test: revealed pleocytosis, notes: elevated protein with normal glucose; Full blood count: were unremarkable; Heart rate: 76, notes: units:beats /min; HIV test: unremarkable; antimyelin oligodendrocyte glycoprotein: unremarkable; CSF Nucleated cells (0-10): 129 /mm3; unremarkable; 4/5; 5/5; unremarkable; Magnetic resonance imaging head: unremarkable; Magnetic resonance imaging spinal: multiple relatively long, notes: segments of increased cord signal diffusely throughout the cervical and thoracic cord with lesions mainly affecting C2-C5 and T2-T7; Metabolic function test: Unremarkable; Oxygen saturation: 98 %; physical examination: decreased strength in the bilateral lower, notes: extremities (muscle power 4/5), decreased vibration sense and proprioception in the bilateral lower extremities with sensory level at T4, and brisk reflexes (3+) in all four extremities with a positive Babinski reflex and ataxic gait. The rest of the physical examination was unremarkable; Reflex test: 3 plus, notes: in all four extremities; Respiratory rate: 16, notes: units: breaths/min; Rheumatoid factor: unremarkable; SARS-CoV-2 test: Negative; Treponema test: unremarkable; Unremarkable; Vitamin B12: unremarkable; West Nile virus test: Unremarkable. Therapeutic measures were taken as a result of myelitis transverse.  A 50-year-old man with no significant past medical history presented to the emergency department with progressive weakness and numbness of the bilateral lower extremities, back pain, and difficult urination for 2 days. He denied fever, chills, headache, dizziness, vision changes, chest pain, shortness of breath, abdominal pain, nausea and vomiting. He had no history of recent trauma, travel or contact with a sick person. He reported COVID-19 infection 10 months earlier with complete recovery without treatment. He had received his second dose of the Pfizer COVID-19 vaccine 20 days previously. His initial vital signs were blood pressure of 136/72 mmHg, temperature of 36.7 degrees C, heart rate of 76 beats/min, and respiratory rate of 16 breaths/min with 98% saturation on room air. The physical examination revealed decreased strength in the bilateral lower extremities (muscle power 4/5), decreased vibration sense and proprioception in the bilateral lower extremities with sensory level at T4, and brisk reflexes (3+) in all four extremities with a positive Babinski reflex and ataxic gait. The rest of the physical examination was unremarkable. The laboratory studies, including complete blood count and comprehensive metabolic panel, were unremarkable. A COVID-19 PCR test was negative. MRI of the brain was unremarkable. However, MRI of the spine (cervical/thoracic/lumbar) revealed multiple relatively long segments of increased cord signal diffusely throughout the cervical and thoracic cord with lesions mainly affecting C2-C5 and T2-T7. Additional work-up including CSF oligoclonal band, angiotensin-converting enzyme, aquaporin 4 receptor antibody (NMO-IgG), antimyelin oligodendrocyte glycoprotein (MOG) antibody, Lyme antibodies, meningitis panel, West Nile virus IgG and IgM, HIV, syphilis rapid plasma reagin, serum vitamin B12, serum copper, antinuclear antibody, antibody to an extractable nuclear antigen, rheumatoid factor and a paraneoplastic CSF panel, was unremarkable. The diagnosis of LETM secondary to COVID-19 vaccination was made by a diagnosis of exclusion. The patient was started on intravenous methylprednisone 1000 mg daily for 5 days. After five doses of methylprednisolone and physical therapy, his lower extremity weakness had improved (muscle power 5/5). He reported improved sensation in both feet, although numbness and tingling persisted. He was started on oral prednisone 1 mg/kg/day for 2 weeks, followed by a gradual taper, and discharged to the acute rehabilitation unit to continue physical therapy. After 1 week of extensive physical therapy, he was discharged home. He continued outpatient physical therapy three times a week and completed recovery in about 1 month.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events myelitis transverse and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.