Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Spinal laminectomy, Spinal operation, X-ray
Clinical narrative: Providers have diagnosed Guillain-Barre; Pt developed tingling in toes and finger; progressed to numbness and climbed up extremities to now include above the wrist down; patient is now unable to ambulate.; trouble swallowing; headache; This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EW0170), via intramuscular route of administration, administered on 06May2021 (at the age of 59-years-old) as SINGLE dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown), via unspecified route of administration, administered on 27May2021(at the age of 59-years-old) for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing. Concomitant medication(s) included Amlodipine (Amlodipine) taken for an unspecified indication, start and stop date were not reported; Atorvastatin (Atorvastatin) taken for an unspecified indication, start and stop date were not reported; Benazepril (Benazepril) taken for an unspecified indication, start and stop date were not reported; Duloxetine (Duloxetine) taken for an unspecified indication, start and stop date were not reported; Omeprazole (Omeprazole) taken for an unspecified indication, start and stop date were not reported. the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19.The patient experienced providers have diagnosed guillain-barre on 12Jul2021, pt developed tingling in toes and finger that have progressed to numbness and climbed up extremities to now include above the wrist down and patient is now unable to ambulate on 12Jul2021, Progression has been over three days. Patient also complained of trouble swallowing and headache on 12Jul2021, patient has underwent lumbar laminectomy on Jun2021. Therapeutic measures were taken with first dose of IVIG last night is due to receive second dose tonight as a result of providers have diagnosed guillain-barre, pt developed tingling in toes, progressed to numbness, patient is now unable to ambulate, trouble swallowing, headache, patient has underwent lumbar laminectomy. Pt was transferred to ICU level of care over night. He is currently still admitted, there is discussion of transfer to another hospital with higher level neurology services at this time. If he remains stable he will stay here. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Guillain-Barre syndrome, Paraesthesia, Hypoaesthesia, Gait inability, Dysphagia and headache cannot be totally excluded 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.