Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mental status changes, Thrombosis
Clinical narrative: has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease; has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease; has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease; diagnosis of a brain blood clot; her mental status decline; This is a spontaneous report from a contactable Nurse (reported for his/her mother). A 61-year-old non-pregnant female patient received second dose of bnt162b2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in May2021 at the age of 61 years old as single dose for covid-19 immunisation. Medical history included hypertension and shellfish allergy, both from an unknown date.  The patient did not experienced Covid-19 prior to vaccination and the patient was not tested for Covid-19 post vaccination. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Batch/Lot No: Unknown. Unable to locate or read the details) on an unspecified date in Apr2021 at the age of 61 years old for COVID-19 immunization. There were no other vaccines received in four weeks and there were no other medications received in two weeks. After the patient received the Pfizer vaccine bnt162b2, her mental status decline in Jul2021 and in Aug2021 the patient was brought to the Emergency room with diagnosis of a brain blood clot the patient has been treated with pradaxa for blood clot, although now in Nov2021 the patient has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease - possibly brought out by bnt162b2. The reported 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. The patient was hospitalized for 5 days. The patient underwent lab tests which included blood work, multiple CT scans, magnetic resonance imaging with unknown results on an unknown date in 2021. Therapeutic measures which included multiple CT scans, magnetic resonance imaging, spinal tap, blood work, and blood thinners were taken as a result of reported events. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Mental status changes, Thrombosis, Ischaemic stroke, Central nervous system vasculitis and Autoimmune disorder. 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.