Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood thyroid stimulating hormone, Body temperature, Dizziness
Clinical narrative: elevated BP 168/89; dizziness; Nystagmus; mental fatigue; felt exhausted; i had a small clot most likely; highest temp 101.2; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I had covid Oct2020", start date: Oct2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster) and Manufacturer unknown), for Covid-19 immunization. The following information was reported: NYSTAGMUS (non-serious) with onset 06Dec2022 at 15:00, outcome "recovered" (Dec2022); DIZZINESS (non-serious) with onset 06Dec2022 at 15:00, outcome "recovered" (Dec2022); BLOOD PRESSURE INCREASED (medically significant) with onset 06Dec2022 at 15:00, outcome "recovered" (Dec2022), described as "elevated BP 168/89"; FATIGUE (non-serious) with onset Dec2022, outcome "recovered" (Dec2022), described as "felt exhausted"; PYREXIA (non-serious) with onset Dec2022, 5 days 15 hrs after the suspect product(s) administration, outcome "recovered" (Dec2022), described as "highest temp 101.2"; THROMBOSIS (medically significant) with onset Dec2022, 17 days 7 hrs after the suspect product(s) administration, outcome "unknown", described as "i had a small clot most likely"; MENTAL FATIGUE (non-serious) with onset Dec2022, outcome "recovered" (Dec2022). The events "elevated bp 168/89", "i had a small clot most likely", "highest temp 101.2", "dizziness", "mental fatigue", "felt exhausted" and "nystagmus" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 168/89; Blood thyroid stimulating hormone: (unspecified date) normal; Body temperature: (unspecified date) 101.2; Full blood count: (unspecified date) normal; eye exam: (unspecified date) Unknown results; Metabolic function test: (unspecified date) normal; SARS-CoV-2 test: (02Jan2023) Negative. Therapeutic measures were not taken as a result of blood pressure increased, pyrexia, dizziness, mental fatigue, fatigue, nystagmus.  Clinical Courses: Fever initially for 36 hours highest temp 101.2. Day 5 while seeing patients in the office the patient sat down to chart and experienced Nystagmus then dizziness for approximately 15 minutes with elevated BP 168/89. (don't have hypertension) went to PCP and BP remained elevated but no neuroimaging was performed. They checked CBC, CMEP and TSH which were all normal. The patient just had a normal eye exam which is 5 weeks since the booster. The next 7 days experienced dizziness, mental fatigue and felt exhausted like patient did when had covid Oct2020. On day 13 woke up and felt better. Thought really had a small clot most likely. Had no health issues and take no medications was 57.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 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 BLOOD PRESSURE INCREASED & THROMBOSIS 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.