Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Cerebrovascular accident, Confusional state, Dysarthria, Laboratory test normal
Clinical narrative: Stroke; Slurred speech; balance was a little off; Little confused; Little bit of vision; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), on 30Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 83 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN5318, Expiry date: 10Feb2021), administration date: 2021, when the patient was 81 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3246, Expiry date: 30Apr2021), administration date: 2021, when the patient was 81 years old, for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FG3527), for COVID-19 immunization. The following information was reported: VISUAL IMPAIRMENT (hospitalization) with onset 12Nov2022, outcome "recovered" (13Nov2022), described as "Little bit of vision"; CONFUSIONAL STATE (hospitalization) with onset 12Nov2022, outcome "recovered" (13Nov2022), described as "Little confused"; DYSARTHRIA (hospitalization) with onset 12Nov2022, outcome "recovered" (13Nov2022), described as "Slurred speech"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 12Nov2022, outcome "recovered" (13Nov2022), described as "Stroke"; BALANCE DISORDER (hospitalization) with onset 12Nov2022, outcome "recovered" (13Nov2022), described as "balance was a little off". The patient was hospitalized for cerebrovascular accident, dysarthria, balance disorder, confusional state, visual impairment (start date: 12Nov2022, discharge date: 13Nov2022, hospitalization duration: 2 day(s)). The events "stroke", "slurred speech", "balance was a little off", "little confused" and "little bit of vision" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab: Unknown results, notes: they did do labs before she was discharged from the hospital, and they were good. Therapeutic measures were taken as a result of cerebrovascular accident, dysarthria, balance disorder, confusional state, visual impairment. Prescribed 325mg regular Aspirin to take once a day.  Clinical course: No other conditions, products, and investigations. Caller mentions that she worked in the OR, the ER, and the last 10-15 years of her nursing career she was in surgical and cardiac ICU. Caller states that she has her own business now. States that she does not do online things because she is 83 years and spends her time with the horses, so she does not have time, she has a secretary for all of that. States that she worked in research for 2 years, so she is calling to mainly notify the research team. Caller states that she is a nurse, she worked 40 years in critical care. States that she has had all of the vaccines. States that morning she was speaking with the veterinarian who looks after the horses and the vet noticed that the caller's speech was so slurred. Caller states that she thought maybe it was just her false teeth. The vet looked the caller in the eyes and told the caller that the caller's speech was drastically slurred, the caller was told by the vet to stand up and put her shoes on and the caller could not do so. The last vaccine she had was on 30Oct2022 and then 12 days later she had a stroke. To have the stroke 12 days after the vaccine is a bit unusual. The vet then took the caller to the hospital. She has slurred speech, her balance was a little off, she was a little confused, a little bit of vision, does not specify what with the vision; caller states she had no headache or anything like that. She was admitted into the hospital, and everything resolved quickly. She was discharged from the hospital the next day on one Aspirin a day. Caller states that she has never been on any medications or had any health issues. States then she had the stroke on 12Nov2022. Now she just takes the Aspirin since the stroke. She has not taken anything else since the stroke either. States that she is in pretty good shape now, her balance is a little off but not too bad. States she does not complain, and she takes her Aspirin as she was instructed. Caller states that she worked in research for a while and does not know if there is a connection. States that it is difficult to say with her age, but her health history is negative, and she has had no problems, has not been on any medications. States that to then have a stroke is drastic. Caller states that she has her physical done yearly and has labs done and they are always within normal limits. States that she has no past history, no neurological problems, no lung problems, no bowel problems, no nothing. She was hit with a stroke out of the blue. States that it was shocking to her. She had no prior symptoms, she just woke up in the morning and boom, her speech was slurred, and her balance was off. States that she felt like something was wrong with her speech, but not until the veterinarian came by and said it. Caller states that it resolved quickly, and she was discharged from the hospital the next day. States that she got to thinking about it, later research wise and wondered if the vaccine was contributory to the stroke. States that she is older, in terrific shape, she has no physical problems. Caller states that with her age and clean bill of health, if she was still in research, she would be looking into it. Caller states that the hospital should have record of her labs. States that she originated in their Emergency Room, they should have all the records. Prior Vaccinations (within 4 weeks) was none. Caller states that she is doing well. She is not saying this all is from the vaccine but working in research she knows it could be connected. This report is not related to a study or programme.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.1 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  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.