Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cerebrovascular accident, Computerised tomogram head, Emotional disorder, Magnetic resonance imaging head
Clinical narrative: Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine; Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine; This is a spontaneous report from a contactable nurse reporting for her husband. The report was not related to a study or programme. A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 5:45pm (at the age of 62-year-old) as single for covid-19 immunisation. Medical history included ongoing High blood pressure, BPH (benign prostatic hyperplasia) from an unknown date and unknown if ongoing and hip replacement for osteoarthritis. It was reported that within the last two years, her husband was not taking medications for this diagnosis. The patient had no family medical history relevant to adverse events. Concomitant medications included Amlodipine taken for high blood pressure; VITAMIN D3, started may be a year ago taken to support strong bones and immune health, curcuma longa rhizome (CURCUMIN TURMERIC), started maybe about a year and a half ago taken for antioxidant benefits, Paracetamol (TYLENOL), started few years ago for sleep and Melatonin, started from two years (sometimes it was a tablet and sometimes it was a sublingual lozengier) taken for sleep; all started on an unspecified date and ongoing. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 5:45pm (at the age of 62-year-old) as single for covid-19 immunisation. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not have any events prior vaccinations. She stated that she was not aware that her husband has had any vaccinations as an adult. On 5May2021 at 3 pm, the patient experienced right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine. The clinical course of the events as follows: She stated that his symptoms began on 05May2021. She reported that on 5May2021, her husband went through the emergency room, and had a stroke alert, called, and then was admitted to the hospital. On 6 May 2021, the patient was hospitalized for Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine. The patient admission diagnosis was left arm ataxia with neglect. The patient had some emotional issues and was not sure if it was from the stroke or from anxiety because of the event. She stated that her husband had a small CVA (cerebrovascular accident), cardiovascular accident, within 3.5 weeks of his second dose of vaccine. She stated that the doctors called his CVA as cryptogenic. On 6May2021, the patient lab tests included: CT scan (Computerized tomogram head) Scan of brain, two: Result: right parietal lobe acute cryptogenic small vessel CVA. MRI (Magnetic resonance imaging head) of the brain shows acute to subacute completed infarct involving the right parietal high convexity, CTA (CT angiography) of the head and neck shows no large vessel occlusion. The patient was discharged on 07May2021, with some lingering problems of his left arm, and spatial concerns. The patient discharge diagnosis was right parietal lobe acute cryptogenic small vessel CVA. Reporter seriousness for Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine was hospitalization. She reported that her husband had no underlying reasons to have the CVA. She reported that from a physical perspective, he was recovered completely. His left arm symptoms, cleared up, by 12May2021. She mentioned that her husband felt his symptoms went away, maybe about 12May2021. The patient was resolved from left arm symptoms on 12May2021, and the other events were resolved on an unspecified date in 2021. She stated that she was not sure if anyone else had reported this, but she would know, that some of the other vaccines had problems.   Further follow-up is needed. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be 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.