Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinusitis, Urinary tract infection, Visual impairment
Clinical narrative: neurological issues/She states she is in the traumatic brain injury category; Fatigue level increasing; Migraine; Postural dizziness; Visual disturbance; Extreme sensitivity to any type of light, light was intolerable to her in may2021; Paresthesia; Numbness has been more on her right side then her left side; Shooting pain primarily in her head; Foot now is rather painful and tender; Her right leg does not work exactly as it should/(R) leg weakness; Difficulty concentrating; Cognitive difficulty; This is a spontaneous report from a contactable physician. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 07Apr2021 09:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included ongoing anxiety for more than 5 years. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for anxiety from an unspecified start date and ongoing. Historical vaccine included Flu vaccine (Manufacturer: Glaxo, Lot/Batch: B7473) on 25Mar2021 via intramuscular in left deltoid at age of 52-year-old; 1st dose of BNT162B2 (Lot: EP7534) on 17Mar2021 at 09:00 am via intramuscular in right arm at age 52-year-old for Covid-19 immunization and experienced worsening headache, hematuria, acute urinary tract infection, sinusitis, yeast infection, increased urinary frequency, allergies reaction to insect bites and neurological issues. The patient experienced neurological issues/she stated she was in the traumatic brain injury category, fatigue level increasing, migraine, postural dizziness, visual disturbance, extreme sensitivity to any type of light, light was intolerable to her in May2021 (event onset from 07Apr2021), paresthesia, numbness had been more on her right side then her left side, shooting pain primarily in her head, foot now is rather painful and tender, her right leg does not work exactly as it should/ (R) leg weakness, difficulty concentrating and cognitive difficulty, all on 07Apr2021 with outcome of recovering.  The patient underwent lab tests and procedures which included CT angiography: no abnormality on 30Jun2021, computerised tomogram head: no abnormality on 11Jun2021. Therapeutic measures were taken as a result of postural dizziness. The events required to visit: Physician office. The events were reported as serious with seriousness criteria: persistent/significant disability/incapacity.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the reported events and 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.