Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Eye swelling; This is a spontaneous report from a contactable nurse.   A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Mar2021 (at age of 74-year-old)(Lot Number: EN6206; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included detached retina, cataract, eye surgery on 12Feb2021, and hit the head on the freezer door. Concomitant medications included hydrochlorothiazide (HTZ) taken for an unspecified indication, start and stop date were not reported; potassium chloride taken for an unspecified indication, start and stop date were not reported; vitamins NOS (MULTIVITAMINS) taken for an unspecified indication, start and stop date were not reported. There was no History of all previous immunization with the Pfizer vaccine considered as suspect or additional vaccines administered on same date of the Pfizer Suspect. There was no prior vaccinations (within 4 weeks).  The patient experienced eye swelling on 08Mar2021. The reported seriousness criteria was medically significant. The events did not result in emergency room visit or physician office visit.  Time the Vaccination Was Given: 2:15-3:00 pm. The patient had the vaccine then she went to her retina specialist right after, she had a detached retina prior to receiving the vaccine. At the retina appointment before the vaccine she didn't have edema within her eye, at this appointment she had new onset edema inside of her eye. The edema was on the right, the vaccine was on the left. The patient knows there are lymph nodes around the eye and she has a weird body. The patient wants to know if other people have experienced this. There is edema inside the eye. The patient wonders if the vaccine interacted with the oil given during the retina exam. The patient had cataract surgery done and then had a hole in her retina following the surgery. The hole got worse and she had to go for surgery on 12Feb2021, then she had 3 month appointments.  The patient didn't not know if she still has the eye swelling, she went back to her retina doctor on 19Apr2021. The retina doctor put her on eye drops after they found the eye swelling. The patient mentioned that she stopped the eye drops that she was taking after her surgery a week before she received the vaccine. The patient hit her head on the freezer door right before her retina detached, the doctors said that it did not cause the retina to detach but she thought it was related because she hit her head really hard.  Therapeutic measures were taken as a result of eye swelling (eye swelling). The outcome of event was unknown. The patient thought this eye swelling may be related to the vaccine but she is unsure.; Sender's Comments: Based on the available information, the company considers that a causal relationship between eye swelling and BNT162B2 vaccine cannot be excluded due to plausible temporal association. 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.