Sex: M
Vaccine: COVID19
Symptoms: Culture, Ophthalmic herpes simplex, Slit-lamp examination
Clinical narrative: Recurrent Keratitis/ suspected viral flare; The initial case was missing the following minimum criteria: no identifiable patient. Upon receipt of follow-up information on 24Aug2023 this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 12May2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpes simplex virus" (unspecified if ongoing), notes: of his right eye. The patient's concomitant medications were not reported. The following information was reported: OPHTHALMIC HERPES SIMPLEX (medically significant) with onset 26May2021, outcome "recovered" (Jun2021), described as "Recurrent Keratitis/ suspected viral flare". The event "recurrent keratitis/ suspected viral flare" required physician office visit. The patient underwent the following laboratory tests and procedures: Culture: Negative; Slit-lamp examination: 360 degrees of peripheral, notes: neovascularization with stromal infiltration; mild peripheral scarring consistent, notes: with resolution of keratitis. Therapeutic measures were taken as a result of ophthalmic herpes simplex. Clinical course: Several physicians in our practice noted a cohort of patients presenting with keratitis in temporal proximity to their COVID-19 vaccinations. We hypothesize that the intense immunological reaction following LNP-formulated mRNAbased COVID-19 vaccinations may have triggered or reactivated keratitis. A 54-year-old man with a history of herpes simplex virus of his right eye presented to our practice with pain, tearing, and a 1-week history of a corneal ulcer in his right eye which started 2 weeks after his first dose of the Pfizer COVID-19 vaccine. He had been treated by a referring ophthalmologist with ofloxacin and tobramycin eye drops with persistent symptoms. Slit-lamp examination of the right cornea revealed 360 degrees of peripheral neovascularization with stromal infiltration. There was a peripheral, non-continuous, curvilinear epithelial defect with an associated infiltrate at 5 o'clock, with mild anterior chamber cellular reaction. Although viral cultures were negative, the patient was treated as a suspected viral flare, given his acute presentation and history of HSV and viral cold sores. He was started on valacyclovir 1 g by mouth twice a day, doxycycline 100 mg by mouth twice a day, a methylprednisolone dose pack, moxifloxacin every 2 h, and erythromycin ointment at bedtime. At 1-week follow-up, the patient reported significant improvement, and slit-lamp exam showed mild peripheral scarring consistent with resolution of keratitis. At 3-week follow-up, the ulcer had resolved.; Sender's Comments: Based on the available information in the case, the causal association between the event Herpes simplex keratitis 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.,Linked Report(s) : US-PFIZER INC-202300285376 Same article/ drug/event and different patient;US-PFIZER INC-202300285149 Same article/ drug/event and different patient;US-PFIZER INC-202300285375 Same article/ drug/event and different patient;US-PFIZER INC-202300285377 Same article/ drug/event and different patient;