Sex: F
Vaccine: COVID19
Symptoms: Infective episcleritis, Intraocular pressure test, Investigation, Visual acuity tests
Clinical narrative: Unilateral Episcleritis Following COVID-19 Booster Vaccination;    A 27-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "myopic astigmatism of both eyes" (unspecified if ongoing); "bilateral allergic conjunctivitis" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "Crohn s disease" (unspecified if ongoing); "mild intermittent asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: INFECTIVE EPISCLERITIS (medically significant), 4 hrs after the suspect product(s) administration, outcome "unknown", described as "Unilateral Episcleritis Following COVID-19 Booster Vaccination". The patient underwent the following laboratory tests and procedures: Intraocular pressure test: 15 mmHg, notes: right eye; 16 mmHg, notes: in the left eye; clinical exam: unremarkable; best corrected visual acuity remained 20/20 bilate; back to baseline; Visual acuity tests: 20/20, notes: bilaterally. Therapeutic measures were taken as a result of infective episcleritis.  Clinical information: A 27-year-old female patient presented with right eye redness, itching, and burning four hours after receiving her COVID-19 mRNA booster vaccine, third total dose. She used artificial tears, but her symptoms were unchanged on the following day which prompted her to seek an ophthalmological exam. She denied photophobia, blurry vision, double vision, foreign body sensation, epiphora, visual flashes, or visual floaters. There were no prior similar episodes with the same vaccine prior two doses. The left eye was asymptomatic and unaffected. The patient's past medical history was significant for myopic astigmatism of both eyes, bilateral allergic conjunctivitis, allergic rhinitis, Crohn's disease, and mild intermittent asthma. On ophthalmic examination best corrected visual acuity remained 20/20 bilaterally. Intraocular pressures measured at 15 mmHg in the right eye and 16 mmHg in the left eye. The right conjunctiva had 2+ injection that blanched with phenylephrine drops. There was no scleral injection, no scleral tenderness, and no physical irritation adjacent to the episcleritis area (eg, no trichiasis). The anterior chamber of the right eye appeared deep and quiet. The remainder of the anterior and posterior segments clinical exam was unremarkable. The patient continued artificial tears and started ibuprofen 200 mg three times daily for one week. The patient adhered to and tolerated the described regimen and one week later, all ocular symptoms and signs resolved. The patient was satisfied by the care she received. She was relieved that her symptoms resolved, and her final vision was not affected. She plans to double check with her rheumatologist before future COVID-19 booster vaccine doses.; Sender's Comments: Based on the available information in the case, the causal association between the events INFECTIVE EPISCLERITIS 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.