Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration, Magnetic resonance imaging, Pain in extremity
Clinical narrative: Stroke/very small stroke in her left thalamus; Sore arm; high cholesterol; blood pressure was trending a little high; patient never got the second dose; Headache; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140), via an unspecified route of administration in the left arm on 19Dec2020 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. The patient's medical history included 2 migraines auras about 10 years ago, left shoulder pain from something minor. Her father had a history of mild strokes, and she had a genetic component from that. He had a big one that rendered him debilitated. He had congestive heart failure, but she did not know if it was ischemic or hemorrhagic stroke. Concomitant medications were not reported. The patient previously had a flu shot in early Nov2020. She took doxycycline a long time ago in the 1990's or early 2000's once and had difficulty breathing. Additional vaccines were not administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks of vaccination. The patient was a hospital chaplain and reported that she got her first dose of the COVID-19 vaccine on 19Dec2020. She wanted to report a possible adverse event. She said that she had a few severe headaches for a few days after the injection and then on 02Jan2021, she had a stroke. It was 2 weeks from the time of the vaccine and 1.5 weeks since the headaches stopped. She also reported that she had a sore arm. The patient stated she got the vaccine at 11:00 on the 19Dec2020, and at about 14:00, she felt the headache, it was not severe, but was strange and it lasted about 3 hours. She has had 2 migraines auras about 10 years ago, and it was similar to that in that it was a different kind of headache. It was not a garden variety headache. She said that she did not remember it enough to describe it fully. She was fine in the evening and the next morning, but said that in the afternoon, she had a more normal headache toward the back of her head. She did not think it was super unusual. The headaches occurred on Sunday, Monday, and Tuesday and then they were done. She felt fine after that. She tried fluoxetine hcl (PROZAC) and had the same kind of feeling in her head like it was something that wasn't supposed to be there. No further details provided. She had a completely normal New Year's Eve and was cross country skiing. She woke up on 02Jan2021 with what felt like tingling in her arm, like her arm fell asleep. Then she realized it was her whole right side that was doing it. It was just this weird sensory tingling that was occurring on her right side. She had no difficulty with speech, cognition, or weakness. She could walk fine and speak fine. She tried to shake it out and said that she looked it up online. She woke up her husband and told him what was happening. It was not going away. It was in her arm, leg, and her side. She called a nurse friend and asked her, and she said that it sounded like a stroke. Her husband drove her to the Emergency room, and they called a Code Stroke on her immediately. She said that it was surreal to be on this side of this. Within 5 minutes they started an IV, did a CT scan, and a blood draw. They did a 50-minute MRI, and they told her that she had a very small stroke in her left thalamus (02Jan2021). They did a CT angiogram to follow up (unspecified date), and she was kept in the hospital from Saturday until Monday (2 days), so she could have an echocardiogram. She said that she had the echocardiogram on Monday (04Jan2021), and her heart was fine. She said that they found high cholesterol which she never had before (unspecified date). She was a healthy person that worked out and was very fit. Her cholesterol was high and had never been high before. She was put on atorvastatin 40 mg and a baby aspirin 81mg. She said that they put her on clopidogrel bisulfate (PLAVIX) in the hospital, but she had abnormal bruising and bleeding, and they stopped that after 3 weeks. The patient stated that her blood pressure was trending a little high (unspecified date), and she was put on amlodipine 5mg on the 17Jan2021 by her primary care physician. The patient stated she still had a little bit of tingling mostly in her right hand. They told her it was normal. She went back to the emergency room on the 05Jan2021, because she had a new symptom, on her right side of her abdomen it felt like she has a tight exercise band around her abdomen. It was like a sensory pressure that comes and goes. She was told that they can get these fluky things with strokes. There was nothing there, but it felt like there was. The patient never got the second dose of the vaccine. Her daughter and her friend thought it was because of the vaccine. She thinks it was just a perfect storm of genetics, stress, and her cholesterol, and then adding the vaccine on top of that. The ER doctors thought it did not have anything to do with it until she came back to the emergency room on the 05Jan2021. The patient made a stroke clinic appointment. She also had to take 2 weeks off from work. She had some post stroke fatigue. She was due for a varicella zoster vaccine rge (cho) (SHINGRIX) series and was waiting for that too. The patient's height used to be 63 inches. The clinical outcome of stroke was recovered with sequelae. The outcome of headache was recovered on 22Dec2020. The outcome of other events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event  Stroke cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.