Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Investigation, SARS-CoV-2 test
Clinical narrative: It was like I had a stroke; This is a spontaneous report received from a Nurse.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 1, single (Lot number: 32030BD) at the age of 69 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: It was high blood pressure but it is normal now; "Asthma" (ongoing); "thyroid" (ongoing). Concomitant medication(s) included: CAPTOPRIL taken for hypertension; VERAPAMIL taken for hypertension; SYNTHROID; ACCOLATE taken for asthma (ongoing). The patient also took other concomitant therapy. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 01Nov2021, outcome "unknown", described as "It was like I had a stroke". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Normal, notes: It was high blood pressure but it is normal now; good now, notes: my pressure was still good; good, notes: I did not even know if I really need this, my pressure is really good now; blood work: Unknown results; do not have lupus; SARS-CoV-2 test: negative. Clinical course: It was reported that the first shot, 3 days later, she could not move her own cup and right arm. She had everything in her right arm. So, She could not move it. It was like She had a stroke. She had no strength in the arm at all. She dropped things and She was left handed. Thank god She did it in the right arm instead of left. It took her month, She had to go to the doctor three times. The primary different people though, because her own doctor was out and She had different doctor in the group and they were all looking at her like She have 10 head, this went on for months that She could not move her arm and She could not even get her coat on. It was in fall when She had the shot, and She could not even get her arm in the coat. She had to her left arm and move her right arm into the socket of the coat to get her coat on and so they did blood work on her to see. Patient wanted to see if she got any antibodies from this vaccine and came back 4 days later, nurse told her you do not have lupus and do not have any antibodies. Patient reported that she took vaccine end of the 2021 that was almost three years ago. She was 72 now, was 69 then because it was complete fall. Patient was given exercise which she could not do because she could not lift her arm. She was not given any medication. Patient was just taking blood pressure medicine and thyroid medicine. It was high blood pressure but it was normal now. Patient was on Verapamil and it is Extended release, ER for years. She left work since and her blood pressure has been fine. Patient's pressure was really good now. She also had Asthma so she had to take this medication. It was called Accolate, but they have a generic now it was called Zafirlukast tablet (Not clarified if consumer is taking brand or generic, hence not captured), 20 milligrams, twice a day.; Sender's Comments: Based on the implied temporal association, the causal relationship between the event stroke and suspect drug 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.,Linked Report(s) : US-PFIZER INC-202400086830 same patient/drug, different dose/events (Dose 2);