Received Jan 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Guillain-Barre syndrome; This is a literature report for the following literature source(s): A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "generalized weakness" (unspecified if ongoing); "nausea" (unspecified if ongoing); "black diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "recovering". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 14 day(s)). The patient underwent the following laboratory tests and procedures: Clostridium test: negative; CSF glucose: 44; CSF protein: 109; CSF white blood cell count: 0; Examination: diffuse areflexia in ankles and knees, but present, notes: in the upper extremities; symmetrical weakness in lower extremities and normal in upper extremities; Lumbar puncture: cytoalbuminologic dissociation with cerebrospinal, notes: fluid (CSF) protein 109, glucose 44 and white blood count 0; Magnetic resonance imaging spinal: did not show acute pathology; Respiratory syncytial virus test: positive. Therapeutic measures were taken as a result of guillain-barre syndrome. Additional information: A 60-year-old female presented with a 6- week history of generalized weakness, nausea and black diarrhea. She received the Pfizer-BioNTech COVID-19 vaccine 6 weeks prior and developed symptoms. Weakness in her legs worsened and progressed to her ribs and right shoulder. She felt numbness in legs up to breasts, but the patient denied difficulty breathing. Examination revealed diffuse areflexia in ankles and knees, but present in the upper extremities; symmetrical weakness in lower extremities and normal in upper extremities. She tested positive for respiratory syncytial virus (RSV) and negative for Clostridium difficile. Lumbar puncture showed cytoalbuminologic dissociation with cerebrospinal fluid (CSF) protein 109, glucose 44 and white blood count 0. Cervical and thoracic spine MRI did not show acute pathology. Her presentation to the hospital was 6 weeks post vaccination and symptoms did not progress. Nadir was within 4 weeks and confirmed the diagnosis of GBS. She obtained 4 courses of IVIg treatment. Following 2 weeks of hospitalization, she was discharged to post-acute care with improvement of lower extremity strength and partial recovery of reflexes. SUMMARY/CONCLUSION: GBS has previously presented as an adverse effect of vaccination. This interesting case of GBS occurred following the first dose of the Pfizer-BioNTech COVID-19 vaccine. While temporal correlation doesn't prove causation, this report emphasizes the importance of monitoring possible vaccine side effects.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event GUILLAIN-BARRE SYNDROME and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Medical History/Concurrent Conditions: Diarrhea; Nausea; Weakness generalised
Test Name: Clostridium difficile test; Test Result: Negative ; Test Name: CSF glucose; Result Unstructured Data: Test Result:44; Test Name: CSF protein; Result Unstructured Data: Test Result:109; Test Name: CSF white blood count; Result Unstructured Data: Test Result:0; Test Name: Examination; Result Unstructured Data: Test Result:diffuse areflexia in ankles and knees, but present; Comments: in the upper extremities; symmetrical weakness in lower extremities and normal in upper extremities; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:cytoalbuminologic dissociation with cerebrospinal; Comments: fluid (CSF) protein 109, glucose 44 and white blood count 0; Test Name: Cervical and thoracic spine MRI; Result Unstructured Data: Test Result:did not show acute pathology; Test Name: respiratory syncytial virus test; Test Result: Positive