Sex: F
Vaccine: COVID19
Symptoms: CSF red blood cell count, CSF white blood cell count, Computerised tomogram head, Cryptococcus test, Cytomegalovirus test
Clinical narrative: Acute Disseminated Encephalomyelitis; The initial case was missing the following minimum criteria with no patient information and considered invalid. Upon receipt of follow-up information on 05Aug2022, this case now contains all required information to be considered valid.  This is a literature report.  A 44-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "renal stone" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: ACUTE DISSEMINATED ENCEPHALOMYELITIS (disability, medically significant), outcome "recovered". The event "acute disseminated encephalomyelitis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiotensin converting enzyme (normal high range 15): 6, notes: Unit=p/mol/L/min; Antibody test: Negative; Blood potassium: 3.4 mEq/l; Borrelia test: Negative; Computerised tomogram head: showed a 2.4 cm low-density mass, notes: in anterior left frontal lobe along with multiple supratentorial and infratentorial lesions consistent with demyelinating disease either multiple sclerosis (MS) or acute disseminated encephalomyelitis (ADEM); Cryptococcus test: Negative; CSF glucose (40-70): 66 mg/dl; CSF immunoglobulin (normal high range 0.6): 1.8 mg/dl; CSF immunoglobulin (0.8-7.7): 11.6 mg/dl; CSF immunoglobulin (normal high range 0.5): 1.8 mg/dl; CSF myelin basic protein (2.0-4.0): 10.2 ug/L; CSF oligoclonal band: No bands; CSF protein (8.0-42.0): 59 mg/dl; CSF protein (15-40): 98 mg/dl; CSF red blood cell count (0-5): 7, notes: Unit=cells; CSF white blood cell count (0-10): 105, notes: Unit=cells; Cytomegalovirus test (normal high range 30): less than 30; Cytomegalovirus test: Negative; Epstein-Barr virus antibody (normal high range 200): 693 IU/ml; Herpes simplex test: Negative; HIV antibody: Non-reactive; Influenza A virus test: Negative; Influenza B virus test: Negative; Meningoencephalitis panel, CSF: Negative; Magnetic resonance imaging head: Multifocal and diffuse, notes: abnormal central cord signal intensity beginning at C3-C4 extending into thoracic spine with focal sparing at C5-C6. Diffuse abnormal central cord signal intensity throughout thoracic spine was favoring ADEM considering recent MRI brain findings; Magnetic resonance imaging spinal: showed multifocal supratentorial predominantly, notes: periventricular lesions with a single lesion in right upper cervical cord and an enhancing 17 mm lesion in left frontal white matter with surrounding edema, again findings consistent with demyelinating disease; in 14 days showed improvement, previous lesions, notes: seemed to decrease in size or resolved. she was discharged on steroid taper with advice to follow up with ophthalmology, urology and neurology as outpatient; Six months later showed resolution, notes: of previously reported demyelinating lesions and no new demyelinating lesions; which showed a 12 mm lesion, notes: in conus at T11-12 level consistent with an active demyelinating plaque; Mycoplasma test (normal high range 0.90): 4.07 mg/dl; Mycoplasma test (normal high range 770): 1943 mg/dl; Ophthalmological examination: stable; Peritoneal fluid analysis: Negative; Physical examination: showed muscle strength 1/5, notes: 0 deep tendon reflexes of bilateral lower extremities, bilateral and equal diminished sensation to touch and pinprick, and sensory level at T3. Gait couldn't be checked since she wasn't able to stand, rest of the physical examination was otherwise normal; SARS-CoV-2 antibody test (normal high range 1.39): 0.09 mg/dl; SARS-CoV-2 test: never had a positive result, notes: twice weekly; Treponema test: Non-reactive; Non-reactive; Varicella virus test: Not detected; Vital signs measurement: stable; West Nile virus test: less than 1.30; less than 0.90; White blood cell count: 12.1 x10 3/mm3. Therapeutic measures were taken as a result of acute disseminated encephalomyelitis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event acute disseminated encephalomyelitis and the 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.