Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Gait disturbance, Incontinence, Magnetic resonance imaging head
Clinical narrative: also became incontinent; difficulty walking; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 09Nov2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable Nurse (patient). This 64-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot Number: EW0171), dose 2, intramuscular, administered in Deltoid Left on 27Apr2021 at 09:56 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing lactose intolerance, hypertension from 1988 and ongoing, diabetes mellitus from 2005 and ongoing, cerebrovascular accident from 2007 and ongoing, atrial fibrillation from 2009 and ongoing, cataract from 2018 and ongoing and tonsillectomy from 1987 and ongoing. Concomitant medications included ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication from an unspecified start date and ongoing; amiodarone (AMIODARONE) taken for atrial fibrillation from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for atrial fibrillation from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN 81) taken for atrial fibrillation from an unspecified start date and ongoing; clonidine (CLONIDINE) taken for hypertension from an unspecified start date and ongoing; fenofibrate (FENOFIBRATE) taken for blood cholesterol from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for atrial fibrillation from an unspecified start date and ongoing; lisinopril (LISINOPRIL) taken for hypertension from an unspecified start date and ongoing; atorvastatin calcium (LIPITOR) taken for blood cholesterol from an unspecified start date and ongoing; potassium chloride (POTASSIUM CHLORIDE) taken for hypokalaemia from an unspecified start date and ongoing; warfarin (WARFARIN) taken for atrial fibrillation, cerebrovascular accident from an unspecified start date and ongoing; and insulin human, insulin human injection, isophane (NOVOLIN 30/70) taken for diabetes mellitus, start and stop date were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EP6955), dose 1, intramuscular, administered in the left deltoid on 29Mar2021 at 15:08 as DOSE 1, SINGLE for COVID-19 immunization with no reported adverse effects. On 28Apr2021, the day following the patient's second dose, she noticed that her left foot was flaccid, dragging and unable to lift it. In two days it continued and progressed to her left knee. In two days it continued and progressed to her right foot, in two days to her right knee and continued to her right hip. At this point , she was unable to walk and could only manage a sliding gait and required use of a cane. The patient also became incontinent on an unspecified date, because she could no longer get to the restroom in her normal timely manner. The patient made an appointment with her primary physician, who thought she had some type of aging disease and referred her to a neurologist. The neurologist ordered a CT scan and an MRI of her brain. Occupational & Physical therapies were prescribed and the patient was referred for a second opinion to specialist because of "gradient susceptibility" and a need to determine whether the patient needed to stop her prescribed baby aspirin and coumadin. The Neurologist instructed her to continue those medications but commented that the patient walked like a drunk. Both neurologists could not determine a cause for her sudden onset ambulation issues. Despite her stroke which resulted in loss of 25% of my abilities, the Pfizer Covid-19 vaccine resulted in an additional loss of 40% of her capabilities. Her gait was now unsteady and she must use an assistive device (cane) that she never needed after her stroke. The adverse event created a financial, physical and emotional hardship for her. To have survived a stroke with a great outcome, but only to have the Pfizer covid-19 vaccine leave her more impaired is a difficult situation to be dealt. The patient underwent lab tests and procedures which included computerised tomogram (11Aug2007): there are no areas of acute intracranial hemorrhage or abnormal extra-axial fluid accumulation, no midline shift or mass effect. Small, wedge-shaped region of slightly decreased attenuation is seen within the posterior left temporal parietal lobe, likely representing small region of subacute ischemia. Tiny region of slightly decreased attenuation is noted within the right side of pons, consistent with region of old ischemia from prior infarct as noted on prior MRI study. Chronic small vessel ischemic changes are seen in the periventricular and subcortical white matter. Ventricular size is within normal limits. There is no acute fracture. The paranasal sinuses are clear; computerised tomogram (06Jul2021): there are no areas of acute intracranial hemorrhage or abnormal extra-axial fluid accumulation. There is no midline shift or mass effect. Small, wedge-shaped region of slightly decreased attenuation is seen within the posterior left temporal parietal lobe, likely representing small region of subacute ischemia. Tiny region of slightly decreased attenuation is noted within the right side of pons, consistent with region of old ischemia from prior infarct as noted on prior MRI study. Chronic small vessel ischemic changes are seen in the periventricular and subcortical white matter. Ventricular size is within normal limits. There is no acute fracture. The paranasal sinuses are clear; magnetic resonance imaging (MRI) head (11Aug2007): there is no evidence of diffusion restriction. Numerous foci of white matter T2 hyperintensity most consistent with chronic microangiopathic ischemic changes. Focal encephalomalacia and gliotic process noted in the left parietal lobe suggestive for chronic infarct. Small chronic right pontine infarct noted. There is no abnormal postcontrast enhancement intracranially. No evidence of intracranial hemorrhage, mass effect, edema, midline shift, hydrocephalus or extra-axial fluid collection.  Multiple small foci of central and peripheral gradient susceptibility identified. Possible etiologies include hypertension and cerebral amyloid angiopathy; and MRI head (10Jun2021): There is no evidence of diffusion restriction. Numerous foci of white matter T2 hyperintensity most consistent with chronic microangiopathic ischemic changes. Focal encephalomalacia and gliotic process noted in the left parietal lobe suggestive for chronic infarct. Small chronic right pontine infarct noted. There is no abnormal postcontrast enhancement intracranially. No evidence of intracranial hemorrhage, mass effect, edema, midline shift, hydrocephalus or extra-axial fluid collection. Therapeutic measures taken included physically therapy and occupational therapy. Clinical outcome of the events was not resolved. The events were assessed as serious (disability).   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of Walking difficulty and incontinent. 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.