Sex: F
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Neurological examination, Protein total
Clinical narrative: Acute Inflammatory Demyelinating Polyneuropathy; This is a literature report for the following literature source(s):  Journal of Clinical Neuromuscular Disease, 2022; Vol:23 (4), pgs:230-231, DOI:10.1097/CND.0000000000000397.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization.The following information was reported: DEMYELINATING POLYNEUROPATHY (medically significant, life threatening), 1 day after the suspect product(s) administration, outcome "unknown", described as "Acute Inflammatory Demyelinating Polyneuropathy". The patient underwent the following laboratory tests and procedures: Antibody test: Negative; Biopsy skin: significantly reduced epidermal, notes: nerve fiber density consistent with length-dependent small fiber neuropathy; CSF cell count: remarkable; Electromyogram: absent peroneal F-waves and, notes: H-reflexes bilaterally, indicative of proximal motor conduction block; Medical Research Council muscular strength: 5/5, notes: throughout; Magnetic resonance imaging head: within normal limits.; Magnetic resonance imaging spinal: multilevel mild disc, notes: degeneration at T 2-3, T 7-8, and a syrinx at T 6-9; Neurological examination: showed bilateral decreased sensation to pain,, notes: temperature, and touch extending from the toes to the shins and the fingers to the forearms; Protein total (20-40): 53 mg/dl; Reflex test: Ankle reflexes were absent with all other reflexes, notes: present and no sensory level; SARS-CoV-2 antibody test: Negative; SARS-CoV-2 test: Negative; Vital signs measurement: normal. Therapeutic measures were taken as a result of demyelinating polyneuropathy.Clinical Course: if the goal of COVID-19 vaccination in 1 billion people is achieved, many people may develop GBS within a few weeks of vaccination by coincidence alone.2 Care must be taken when attributing a particular event directly to a vaccine, with emphasis that temporal associations cannot automatically to be translated to causality. Presently, the benefits of vaccination greatly outweigh the risks of COVID-19 infection in both morbidity and mortality.2 Conversely, the reported increase in GBS cases with vaccination does warrant continued post vaccination surveillance because rare occurrences of vaccine-related neurological complications are feasible. If detected and treated rapidly, this may result in improved clinical outcomes  Follow-up (09Jun2022): This is a literature report for the following literature source(s): Journal of Clinical Neuromuscular Disease, 2022; Vol: 23(4), pgs: 230-231, DOI: 10.1097/CND.0000000000000397. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  Updated information included: Primary reporter, literature information, patient demographics, RMH, Lab data (antiganglioside antibodies, skin biopsy, Cerebral spinal fluid, Electromyography, Medical Research Council muscular strength, Brain Magnetic Resonance Imaging, Thoracic spine Magnetic Resonance, Neurological examination, protein, Ankle reflexes, COVID-19 antibodies, nasopharyngeal SARS-CoV-2 screen nucleic acid, Vital signs) and Product dosage were updated.  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, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.  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.