Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Guillain-Barre syndrome; This is a literature report for the following literature source(s). A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), 60 days after the suspect product(s) administration, outcome "recovering" (reported as partial recovery). The clinical course was reported as follows: the patient experienced lower back pain, numbness and tingling of the bilateral lower extremities, urinary retention and constipation. The patient underwent the following investigations: a magnetic resonance imaging (MRI) of the spine, which demonstrated signs of osteoarthritis with the spinal cord intact and nerve conduction and electromyography studies, which revealed demyelination and dysfunctions in the engagement of distal muscles below the knee. Therapeutic measures were taken as a result of guillain-barre syndrome, which included intravenous immunoglobulin (IV IG).; Sender's Comments: Given the compatible time association, the reasonable possibility that the event Guillain-Barre syndrome is related to BNT162b2 administration cannot be completely excluded. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. This case will be reassessed should additional information become available. 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.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Test Name: electromyography studies; Result Unstructured Data: Test Result:demyelination and dysfunctions in the engagement; Comments: of distal muscles below the knee; Test Name: MRI of cervical spine; Result Unstructured Data: Test Result:signs of osteoarthritis with the spinal cord; Comments: intact; Test Name: Nerve conduction; Result Unstructured Data: Test Result:demyelination and dysfunctions in the engagement; Comments: of distal muscles below the knee