Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Memory impairment, Unresponsive to stimuli, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 81-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: the patient was diabetic prior to the stroke, but it was controlled then. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Date and Lot Number for the patient's first dose of the Pfizer Covid Vaccine was unknown), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 23Feb2021, outcome "not recovered", described as "Stroke"; UNRESPONSIVE TO STIMULI (medically significant) with onset 23Feb2021, outcome "unknown", described as "unresponsive"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "determine if A-Fib caused the patient's stroke"; BRAIN INJURY (medically significant), outcome "unknown", described as "affected the patient's brain"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "affected her memory, it affected everything"; APHASIA (non-serious), outcome "unknown", described as "was unable to speak"; DYSPHAGIA (non-serious), outcome "unknown", described as "PEG tube placed because the stroke affected her ability to swallow"; BLOOD GLUCOSE ABNORMAL (non-serious), outcome "unknown", described as "patient's sugar levels are affected poorly"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "patient now walks slowly and needs assistance"; INSULIN THERAPY (non-serious), outcome "unknown", described as "patient is now also insulin reliant"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "cannot take care of herself"; BALANCE DISORDER (non-serious), outcome "unknown", described as "The patient's balance has been uncertain since the stroke". The patient was hospitalized for cerebrovascular accident (start date: 23Feb2021, discharge date: 11Mar2021, hospitalization duration: 17 day(s)). The event "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: Unknown results; Weight: 110-111 lbs. Therapeutic measures were taken as a result of dysphagia. Clinical course: The patient was diabetic prior to the stroke, but it was controlled. Since having the stroke, the patient had to have a PEG tube placed because the stroke affected her ability to swallow. The PEG tube is for the patient's meals. There is constant monitoring of the patient's sugar levels. The patient's sugar levels are affected poorly by the unspecified formula type that is for the patient's PEG Tube. The patient also had to have a Loop Recorder placed since having the stroke. They placed this Loop Recorder to try and determine if A-Fib caused the patient's stroke. The patient's balance has been uncertain since the stroke. The patient now walks slowly and needs assistance. The patient was completely independent before the stroke. Caller states that the patient is now also insulin reliant due to the unspecified formula used in the patient's PEG Tube. The patient has had multiple hospitalizations from the stroke and cannot take care of herself. The patient cannot cook or do things that she used to be able to do. The stroke affected the patient's brain as well, it affected her memory, it affected everything. The patient is not the same person as she was before the stroke.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.