Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Computerised tomogram, Headache, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: Plavix for clots; Loss ability to put to see the lines on road; Peripheral vision impacted; Blood sugar 439; Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 at 15:15 as dose 4 (booster), single (Lot number: GJ6739) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; VALSARTAN; OZEMPIC. Vaccination history included: Covid-19 vaccine (Dose 1/ Dose 2, Primary immunization series completed, 'Manufacturer unknown'), for COVID-19 immunization; Covid-19 vaccine (Dose 3, 'Manufacturer unknown'), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE ABNORMAL (hospitalization) with onset 12Dec2022, outcome "recovering", described as "Blood sugar 439"; HEADACHE (hospitalization) with onset 12Dec2022, outcome "recovering"; VISUAL IMPAIRMENT (hospitalization) with onset 12Dec2022, outcome "recovering", described as "Loss ability to put to see the lines on road"; VISUAL FIELD DEFECT (hospitalization) with onset 12Dec2022, outcome "recovering", described as "Peripheral vision impacted"; THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Plavix for clots". The patient was hospitalized for thrombosis, visual impairment, visual field defect, blood glucose abnormal, headache (hospitalization duration: 1 day(s)). The events "plavix for clots", "loss ability to put to see the lines on road", "peripheral vision impacted", "blood sugar 439" and "headache" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose abnormal: 439, notes: Blood sugar 439; Computerised tomogram: Unknown Results; Magnetic resonance imaging: Unknown Results; SARS-CoV-2 test: NO, notes: If covid tested post vaccination: No; Scan: Unknown Results. Therapeutic measures were taken as a result of thrombosis, visual impairment, visual field defect, headache.  Clinical course: Report about covid treatment yes, Reporter type patient, No other vaccine in four weeks, Dose received more than 3, Loss ability to put to see the lines on road Peripheral vision impacted Driving was dangerous could not understand how to park Could not understand how to put on my pants or shoes on Dec19-21. Headache right after Blood sugar 439. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. No days hospitalization 1, If treatment AE yes, If covid prior vaccination yes, If covid tested post vaccination no.; Sender's Comments: Based on the available information in the case, the causal association between the events THROMBOSIS, VISUAL IMPAIRMENT, VISUAL FIELD DEFECT,  BLOOD GLUCOSE ABNORMAL, HEADACHE 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.