Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myelitis, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Following a complex neurologic work-up the patient was diagnosed with suspected transverse myelitis; Numbness and tingling of the right upper extremity, this progressed to the right torso and right lower extremity; Numbness and tingling of the right upper extremity, this progressed to the right torso and right lower extremity; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 61 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN9581), administration date: 17Feb2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6202), administration date: 10Mar2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: MYELITIS (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Following a complex neurologic work-up the patient was diagnosed with suspected transverse myelitis"; HYPOAESTHESIA (disability), PARAESTHESIA (disability) all with onset 21Nov2021, outcome "not recovered" and all described as "Numbness and tingling of the right upper extremity, this progressed to the right torso and right lower extremity". The events "following a complex neurologic work-up the patient was diagnosed with suspected transverse myelitis" and "numbness and tingling of the right upper extremity, this progressed to the right torso and right lower extremity" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of myelitis, hypoaesthesia, paraesthesia.  Clinical course: It was reported that patient began experiencing numbness and tingling of the right upper extremity, this progressed to the right torso and right lower extremity. Following a complex neurologic work-up the patient was diagnosed with suspected transverse myelitis, most likely caused by recent vaccination. It was reported that prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient was not tested for COVID-19. Patient had no known allergies. Device Date was reported as 22Jul2022.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association  of suspect  cannot be excluded for  reported events .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