Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inflammation, Scan, Uveitis
Clinical narrative: Was sick with Covid; Was sick with Covid; it is possibly inflammation from the vaccine; after getting the vaccine she developed a new eye condition called Uveitis; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 29Dec2020 at 21:35 as dose 1, single (Lot number: EK9231, Expiration Date: 30Apr2021) at the age of 40 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "eye condition related to macular degeneration" (unspecified if ongoing), notes: eye condition related to macular degeneration   , Her condition was stable and the original eye condition was stable as of Oct2020. For 3 or 4 months, it was stable. There were no concomitant medications. The following information was reported: UVEITIS (medically significant) with onset Dec2020, outcome "unknown", described as "after getting the vaccine she developed a new eye condition called Uveitis"; INFLAMMATION (non-serious) with onset Jun2021, outcome "not recovered", described as "it is possibly inflammation from the vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Was sick with Covid". The event "after getting the vaccine she developed a new eye condition called uveitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Scan: inflammation is still there, notes: they do those every single month. Therapeutic measures were taken as a result of uveitis, inflammation. Clinical course: Caller states she had one of the first Pfizer vaccines in Dec2020. She had an underlying eye condition that was felt to be auto immune and may have been virus related. When she got the Pfizer vaccine in Dec2020, shortly after that, she had a new eye condition that came up. She was wondering if she needed to report this under reportable symptoms. She states it is called uveitis. She states the new condition is in a different spot in her eye and states that was new, after the vaccine. She states it was the middle of Jun2021 that the eye problem was occurring, or was in the late spring of 2021. She states she was not able to get in to see Dr. (name withheld) until the end of Jun2021. It took her a month to get in and it was kind of delayed. They put her on high dose steroids, Prednisone and Methotrexate. She had a steroid seed injection, she thinks 2 or 3 times. She had to get subcutaneous Methotrexate because she was sick with Covid and could not take it. The inflammation was getting worse. Now, she is going to have to go on Humira Subcutaneous, to help with the inflammation because it just keeps popping up. Caller states she told her hospital where she works, she was waiting to take the second dose of Pfizer because the inflammation in her eye was out of control. She states they wanted her to take it anyway. Her doctor wrote her a note that it needed to be waived until they could get the eye condition under control. It never got under control. She states they both occurred in 2 different spits in her eyes. When she was having the macular  thing happen,  they though it  was histoplasmosis but they werent sure that the virus was affecting the retina. Another eye doctor thought it was something else and they did a full workup. She started having injections and it kind of subsided. This new inflammation was in a different layer of the eye. They said this new inflammation happened in the blood vessels or in the third layer down. It looked like mountains on the scans, of inflammation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Uveitis, inflammation, Drug ineffective, COVID-19 cannot be completely 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.