Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood thyroid stimulating hormone, C-reactive protein, Carcinoembryonic antigen
Clinical narrative: acute inflammatory demyelinating polyneuropathy; This is a literature report for the following literature source(s): PRIVACY.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "coronary artery disease" (unspecified if ongoing); "diabetes mellitus" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "cryptogenic cirrhosis" (unspecified if ongoing); "liver transplantation", start date: Jun2020 (unspecified if ongoing); "hospitalized", start date: Feb2021 (unspecified if ongoing), notes: for subacute lower extremity weakness and paresthesia ascending to bilateral hands over 4 days. Concomitant medication(s) included: PREDNISONE. Past drug history included: Cyclosporine; Immunoglobulins, notes: IV. The following information was reported: SUBACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY (medically significant), outcome "recovering", described as "acute inflammatory demyelinating polyneuropathy". The patient underwent the following laboratory tests and procedures: aspartate aminotransferase: 149 IU/l, notes: High; autoantibody test: negative; bacterial test: negative; biopsy liver: high-grade neuroendocrine tumor of unclear origin, notes: plus mild acute rejection in his graft; blood alkaline phosphatase: 233 IU/l, notes: High; blood bilirubin: 2.1 mg/dl, notes: High; blood chromogranin a: 403 ng/ml, notes: ULN less than 93 ng/mL; blood culture: negative; blood glucose: 87 mg/dl, notes: High; blood immunoglobulin a: 214 mg/dl; blood immunoglobulin g: 1194 mg/dl; blood immunoglobulin m: 71 mg/dl; blood thyroid stimulating hormone: 1.83 MiU/L; carcinoembryonic antigen: 36 ng/ml, notes: ULN lessthan3 ng/mL; c-reactive protein: 1 mg/dl; cryptococcus test: negative; culture: negative; culture urine: unknown; cytology: negative for carcinoma; cytomegalovirus test: negative; electrophoresis protein: ew tiny oligoclonal bands in gamma region; epstein-barr virus test: negative; flow cytometry: negative for atypical or malignant cells; fungal test: negative; negative; hiv test: negative; magnetic resonance imaging head: nornal; magnetic resonance imaging hepatobiliary: innumerable new bilobar lesions; magnetic resonance imaging spinal: normal; mycobacterium tuberculosis complex test: negative; neurological examination: bilateral lower extremity weakness, hyporeflexia, notes: and loss of pinprick sensation; physical examination: could only stand with support and required, notes: assistance for ambulation; platelet count: 89000 uL, notes: Low; polymerase chain reaction: negative; negative; protein total: 107 mg/dl, notes: High; red blood cell count: 2, notes: cells/cmm; red blood cell sedimentation rate: 20; sars-cov-2 test negative: negative, notes: by nasopharyngeal swab PCR; treponema test: nonreactive; vitamin b12: 884 pg/mL; white blood cell count: 1, notes: cell/cmm; white blood cell count: 3500 uL, notes: Low. Therapeutic measures were taken as a result of subacute inflammatory demyelinating polyneuropathy.; Sender's Comments: Based on the current available information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of the Subacute inflammatory demyelinating polyneuropathy cannot be fully 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 RAs, Ethics Committees, and Investigators, as appropriate.