Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram head, Hypoaesthesia, Lacunar stroke, Magnetic resonance imaging
Clinical narrative: stroke/stroke symptoms/ a small lacunar stroke on left side of brain; Numbness of right hand and fingers; focal seizures; aphasia/Expressive aphasia; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 88-year-old female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 87 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "atrial fib" (ongoing), notes: patient was having long runs of atrial fib; "High cholesterol" (ongoing); "Stroke", start date: Jan2022 (ongoing), notes: stroke in Jan 2022; the stroke that was aborted. Concomitant medication(s) included: LIPITOR oral taken for blood cholesterol increased (ongoing); METOPROLOL oral taken for atrial fibrillation (ongoing); VALSARTAN taken for hypertension (ongoing). Vaccination history included: Flu vaccine, for influenza Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (hospitalization) with onset 17Sep2023, outcome "recovered" (17Sep2023), described as "Numbness of right hand and fingers"; PARTIAL SEIZURES (hospitalization) with onset 17Sep2023, outcome "unknown", described as "focal seizures"; LACUNAR STROKE (hospitalization) with onset 17Sep2023, outcome "recovered" (17Sep2023), described as "stroke/stroke symptoms/ a small lacunar stroke on left side of brain"; APHASIA (hospitalization) with onset 04Oct2023, outcome "recovered" (05Oct2023), described as "aphasia/Expressive aphasia". The patient was hospitalized for lacunar stroke, hypoaesthesia, partial seizures (start date: 17Sep2023, discharge date: 20Sep2023, hospitalization duration: 4 day(s)); for aphasia (start date: 04Oct2023, discharge date: 05Oct2023, hospitalization duration: 2 day(s)). The events "stroke/stroke symptoms/ a small lacunar stroke on left side of brain", "numbness of right hand and fingers", "focal seizures" and "aphasia/expressive aphasia" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (unspecified date) Negative at this time for a stroke or bleed; Magnetic resonance imaging: (2023) focal seizure; (17Sep2023) Stroke, notes: radiologist that looked at it said the MRI showed a sub-acute stroke; (18Sep2023) a small lacunar stroke on left side of brain; (18Sep2023) showed small stroke; Weight: (unspecified date) 115-118 lbs. Therapeutic measures were taken as a result of lacunar stroke, hypoaesthesia, partial seizures. Clinical course: Reporter stated she was calling on behalf of her mother who had been prescribed Keppra (Levetiracetam). Reporter was also a recently retired nurse/RN. When reporter was getting the new Pfizer Comirnaty vaccine yesterday she noted that the paperwork asked if she were on any anti-convulsants and since her mother was taking Keppra, it lead to some concern about her mother receiving the new Comirnaty 2023-2024 vaccination. She wanted to know more about possible danger in receiving Comirnaty 2023-2024 while taking Levetiracetam/Keppra. Reporter stated that her mother has had the original vaccine and all of the covid booster vaccines, All vaccinations were manufactured by Pfizer. She stated her mother's last covid booster was administered last Fall. She stated that this year in early to mid Sep, her mother experienced a stroke that showed up on MRI and possible bifocal seizures and was hospitalized for 4 days. Two weeks after her mother went home, reporter went over to check on her and her mother was experiencing sudden onset acute expressive aphasia and could not string 2 words together. She was rushed back to the hospital and the aphasia lasted about 8 hours. It was thought she also might be also having focal seizures, which expressed itself through sudden onset of acute expressive aphasia. Doctor's concluded that she had not "restroked" or had a stroke extension and thought she might have experienced a bifocal seizure. However, doctors were not sure if it was a seizure and reporter was not sure that a seizure would cause this aphasia. On this second hospitalization the only thing doctors did was increase patient's Levetiracetam dose from 500mg bid (twice a day) to 750mg bid (twice a day). Reporter stated she saw two internet sites (sites could not be recalled) which linked mRNA vaccines and levetiracetam with an increase seizure incidence of 2-4%. She saw other internet sites that did not mention levetiracetam increasing seizure risk, but did include Dilantin, "phenobarb", and carbamazepine. Reporter stated she was almost certain the covid vaccinations and this current issue with her mother were not related as her last covid vaccination was last Fall. Thought this was what caused the stroke. When she had the aborted stroke in Jan2022 patient was having long runs of atrial fib. Was in with cardiologist and had heart monitor placed for 2 weeks. She was having a Bad genes. Concomitant Lipitor was doubled from 20mg once a day 40mg after the Sep2023 hospitalization. Dates when patient was in hospital for Expressive aphasia: 4Oct2023 to 5Oct2023. Dates when patient was in hospital for Numbness of right hand and fingers: 17Sep2023 to 20Sep2023. Dates when patient was in hospital for Stroke symptoms: 17Sep2023 to 20Sep2023. Dates for Concomitant Products Lipitor Metoprolol Valsartan: (Start: Unspecified Stop: Ongoing). They increased her Keppra dose from 500mg BID to 750mg BID. She clarified with the first admission stoke was confirmed by a MRI. She had a small lacunar stroke on left side of brain. She reiterated she did not related the stroke or expressive aphasia to the Covid Vaccine. Sadly she had bad genes that run in the family. She was the oldest of 4 children and is the only surviving one. Explained mother, the patient, lives 5 minutes away. She would not be able to assist in answering question. She saw cardiologist and had primary care doctor that was with internal medicine. Patient was taken to the hospital on 17Sep2023. Reporter went to the patient's house around 11 am. Patient complained of having right hand numbness and numbness of right fingers. Historically, patient had an aborted stroke Jan 2022. Patient was rushed to the hospital and she was there within the window of time for thrombolytics. On 17Sep2023 patient was complaining of numbness of right hand fingers and was told she needed to go to the hospital. Explained Numbness of right hand and fingers, why took the ER. Patient had a head CT which was negative at this time for a stroke or bleed. Then they wanted to admit her for 24 hours due to previous history of having an aborted CVA in Jan 2022. On 18Sep2023 they did a MRI of the head and discovered she had the small left lacunar infarct. They were blown away by the details. On 17Sep2023 patient was complaining of the numbness and reporter thought patient was having a TIA. They were all blown away the MRI on 18Sep showed small stroke. Stroke symptoms was the reason admitted to the hospital. This was the diagnosis as the reason why admitted. She was in for four days. However, provided dates of hospitalization as confirmed 17Sep2023 to 20Sep2023. Details captured as provided by reporter. Reporter clarified Keppra to be, Levetiracetam. Patient started on as clarified Levetiracetam starting on 18Sep2023 and went home from hospital on this dose and was on this dose 500mg as clarified two times a day by mouth. Then 05Oct2023, patient's dose was change to 750mg two times a day by mouth by neurology. Further explained, it was unknown if patient actually had a stroke on 17Sep2023. The radiologist that looked at it said the MRI showed a sub-acute stroke, a recent stroke and asked if patient had stroke on 17Sep2023 or if it was before this date. The actual date of stroke is unknown. This resolved after a coupe of hours or so. It was intermittent. She recovered from the numbness. She had a stroke that was not aborted and she was feeling effects of that. When reporter went the morning of 04Oct2023 to her mother's to check vitals the patient's speech was so garbled could not put more than 2 words together. She could not understand one word of that. Other than that, her mother was walking and dressed herself. Reporter informed patient this was a sign of a stroke and needed to go to the hospital. Patient put on her sneakers and tied them. Only thing patient was experiencing was this severe expressive aphasia. This resolved after 12-18 hours. Around 7am 05Oct2023, when walked into the room patient was awake laying in bed. When reporter walked in she said "hi (withheld)." Then stated it had 99.9% resolved. She might have had words seeking or searching, but it was minimal. That was why said it resolved within 12-18 hours. Reporter confirmed it has resolved completely. Confirmed patient was admitted to the hospital. Patient was in the ER first. Reporter informed them the CT won't show stroke right away and requested they bypass the CT and went straight to MRI. Once they did the MRI it was determined patient did not re-stroke or re-extend her stroke. However, she was still admitted and neurology followed. Due to results of MRI this was why suspicious she had a focal seizure. Reporter explained she had never known focal seizure to cause only expressive aphasia. It's suspected patient had focal seizure, but was not sure. Covid Booster Vaccine, Had this in the fall of last year. It was either Sep2022 or Oct2022. Think this is what caused the stroke. When she had the aborted stroke in Jan 2022 patient was having long runs of atrial fib. Was in with cardiologist and had heart monitor placed for 2 weeks. Communication: Details captured as clarified.  Causality assessment: The Result of Assessment by global introspection method by primary source reporter was reported as No.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and known safety profile the reported events are assessed as unrelated to BNT162b2.  The patient's history of ongoing hypertension, atrial fibrillation, hypercholesterolemia and stroke are risk factors for the  reported lacunar stroke, partial seizures, hypoaesthesia and aphasia.  The events are intercurrent  conditions.  Case will be reassessed if additional information is received.    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-202300359271 Same reporter/patient, different drug/AE;