Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Computerised tomogram, Diplopia, Dizziness, Echocardiogram
Clinical narrative: Vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes); Vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes); Vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes); Dizziness, Giddiness, lightheadedness; This is a spontaneous report from a contactable Other Health Professional. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the right arm on 12Feb2021 at 10:00 (Batch/Lot number was not reported) at 69-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. Medical history included blood pressure high (HBP) from an unknown date and unknown if ongoing, atrial fibrillation (A-fib) from an unknown date and unknown if ongoing; and relevant past drug history: Yes, as reported (no details provided). Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; and others as reported. On 12Feb2021 at 14:00, the patient experienced: vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes) (hospitalization, medically significant), and dizziness, giddiness, lightheadedness (hospitalization).  The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included computerised tomogram (CT): result was not provided on an unspecified date, echocardiogram: result was not provided on an unspecified date, Nasal Swab: negative on 24Apr2021 (post vaccination). Therapeutic measures were taken as a result of the events, which included CT and echocardiogram (as reported). The clinical outcome of the events: vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes) was recovered on an unspecified date. The clinical outcome of the events: dizziness, giddiness, lightheadedness was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender's Comments: Based on a temporal association, a causal relationship between the reported events partial vision loss for a few seconds, unfocused spots in vision, double vision and dizziness, and the vaccine BNT162B2 cannot be completely excluded. The causality was confounded by the patients preexisting cardiovascular conditions including hypertension and atrial fibrillation and multiple concomitant medications.  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.