Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment, SARS-CoV-2 test
Clinical narrative: Patient states the entire weekend unable to think cleary, delayed thought process; hard time forming words; Elevated blood pressure; Patient states the entire weekend unable to think cleary, delayed thought process; dont feel like myself; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 at 10:15 as dose 4 (booster), single (Lot number: GL0087) at the age of 61 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 11Feb2023, outcome "unknown", described as "Elevated blood pressure"; MENTAL IMPAIRMENT (medically significant), BRADYPHRENIA (non-serious) all with onset 11Feb2023, outcome "unknown" and all described as "Patient states the entire weekend unable to think cleary, delayed thought process"; FEELING ABNORMAL (non-serious) with onset 11Feb2023, outcome "unknown", described as "dont feel like myself"; APHASIA (non-serious) with onset 11Feb2023, outcome "unknown", described as "hard time forming words". The events "patient states the entire weekend unable to think cleary, delayed thought process", "hard time forming words", "elevated blood pressure" and "dont feel like myself" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Elevated; SARS-CoV-2 test: (14Feb2023) Pending, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of mental impairment, aphasia, blood pressure increased, bradyphrenia, feeling abnormal.  Additional information: Other medications patient received in two weeks were Blood Pressure Medications. Prior to vaccination, was the patient was not diagnosed with COVID-19. Patient stated "the entire weekend unable to think cleary, delayed thought process, hard time forming words, do not feel like myself. Elevated blood pressure". Adverse event start date was reported as 11Feb2023 12:00 AM.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 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.