Report #2882848

Overview

Sex

Male

Age

Age unknown

State

TX

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

diagnosed with GBS; This is a literature report for the following literature source(s). A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant, life threatening), outcome "unknown", described as "diagnosed with GBS". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of guillain-barre syndrome. Clinical course: Introduction: Distribution of the coronavirus vaccine became a beacon of light throughout the world at the end of 2020 and in early 2021 given the significant death toll and morbidity as well as economic collapse caused by the novel SARS-CoV-2 (COVID-19). Preliminary results from the vaccine testing showed very mild side effects, mostly flu-like symptoms. However, there were isolated cases of neurological symptoms, most prominently Bell's palsy, also noted. Therefore, it was clear that the vaccine may have some neurological manifestations as well. Literature also shows that infection with the virus had been linked to Guillain–Barré syndrome (GBS) in a handful of case reports. Case report: A 65-year-old male who had received the second dose of the Pfizer-BioNTech COVID-19 Vaccine developed neurological symptoms 10 days later. His symptoms started with headache and body aches, quickly progressing to lower extremity weakness, unsteady gait, and neuropathic pain throughout his extremities. He tested negative for COVID-19 infection. He was subsequently diagnosed with GBS and treated with IVIg. Conclusion: Given the severity of this syndrome and potential for other neurologic manifestations, further studies on the safety of the Pfizer-BioNTech COVID-19 Vaccine may be warranted.; Sender's Comments: Based on the available information the company considers that there was not a reasonable possibility that the event Guillain-Barre syndrome was related to BNT162b2. There is no compelling evidence to implicate suspect drug with the event and more likely related to underlying/intercurrent medical condition. 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.

Lab data

Test Name: COVID-19 infection test; Test Result: Negative