Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Paraesthesia, Protein total, SARS-CoV-2 test
Clinical narrative: diagnosis of GBS after lumbar puncture showed high protein levels; diagnosis of GBS after lumbar puncture showed high protein levels; weakness; Started with numbness and tingling in hands within 4 hours of injection/Progressed to full arms then legs; Started with numbness and tingling in hands within 4 hours of injection/Progressed to full arms then legs; This is a spontaneous report from a contactable other health care professional (patient). A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0165), via an unspecified route of administration, in the left arm on 12Aug2021 at 12:15 (at the age of 46-years-old) as single dose for COVID-19 immunisation. Medical history included covid-19. Known allergies included clindamcycin, flu shot, adhesive tape. Concomitant medications included topiramate (TOPAMAX), magnesium, melatonin, tocopherol (VIT E), ergocalciferol (VIT D), ascorbic acid (VIT C) and vit B (VITAMIN B COMPLEX) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 12Aug2021 at 16:00, the patient experienced, started with numbness and tingling in hands within 4 hours of injection. Progressed to full arms then legs. Hospitalized 2 days after injection, in ICU, with diagnosis of GBS (Guillain-Barre syndrome) after lumbar puncture showed high protein levels on 14Aug2021. Spent 5 days in hospital. Received IVIG, MRI of spine and brain. Still with weakness and not fully recovered. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event), disability or permanent damage. Number of days hospitalization was 5. Patient had received treatment for event was IVIG. On 14Aug2021, the patient underwent lab tests and procedures which included lumbar puncture: unknown result, magnetic resonance imaging head: unknown result, magnetic resonance imaging spinal: unknown result, protein total: high and nasal swab sars-cov-2 test: negative. Outcome of the event weakness was unknown and all other events recovered with sequel on Aug2021.; Sender's Comments: Based on the available information in the case, the causal association between the events Guillain-Barre syndrome, CSF protein increased , hypoesthesia, paresthesia, and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.