Received Dec 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
had already had a cataract developing in his left eye; diagnosed with uvetistis; vision impairment in the right eye/ left eye, so he was already experiencing vision issues in that eye; really bad headache on the right side of head; excruciating eye pain; Reading was difficult and redness developed in the right eye; Reading was difficult and redness developed in the right eye; eye pressure was high in the right eye; diagnosed with iritis; TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Nov2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: READING DISORDER (disability), OCULAR HYPERAEMIA (disability) all with onset 28Nov2024, outcome "unknown" and all described as "Reading was difficult and redness developed in the right eye"; IRITIS (disability) with onset 28Nov2024, outcome "unknown", described as "diagnosed with iritis"; UVEITIS (disability, medically significant) with onset 28Nov2024, outcome "unknown", described as "diagnosed with uvetistis"; EYE PAIN (disability) with onset 28Nov2024, outcome "unknown", described as "excruciating eye pain"; INTRAOCULAR PRESSURE INCREASED (disability) with onset 28Nov2024, outcome "unknown", described as "eye pressure was high in the right eye"; CATARACT (disability, medically significant) with onset 28Nov2024, outcome "unknown", described as "had already had a cataract developing in his left eye"; HEADACHE (disability) with onset 28Nov2024, outcome "unknown", described as "really bad headache on the right side of head"; VISUAL IMPAIRMENT (disability) with onset 28Nov2024, outcome "unknown", described as "vision impairment in the right eye/ left eye, so he was already experiencing vision issues in that eye". The events "had already had a cataract developing in his left eye", "diagnosed with uvetistis", "vision impairment in the right eye/ left eye, so he was already experiencing vision issues in that eye", "really bad headache on the right side of head", "excruciating eye pain", "reading was difficult and redness developed in the right eye", "eye pressure was high in the right eye" and "diagnosed with iritis" required physician office visit. The patient underwent the following laboratory tests and procedures: Intraocular pressure test: (28Nov2024) high. Clinical course: The patient received the COVID vaccine and then almost immediately started to experience vision impairment in the right eye. Patient experienced a really bad headache on the right side of head and excruciating eye pain. The patient had already had a cataract developing in his left eye, so he was already experiencing vision issues in that eye. Reading was difficult and redness developed in the right eye. The patient went to visit an eye doctor and was told the eye pressure was high in the right eye. The patient was diagnosed with iritis and then eventually diagnosed with uveitis. The patient has been back and forth to multiple eye doctors and specialists in the past year. The reporter's assessment of the causal relationship of "had already had a cataract developing in his left eye", "diagnosed with uvetistis", "vision impairment in the right eye/ left eye, so he was already experiencing vision issues in that eye", "really bad headache on the right side of head", "excruciating eye pain", "reading was difficult and redness developed in the right eye", "eye pressure was high in the right eye" and "diagnosed with iritis" with the suspect product(s) BNT162b2 omicron (kp.2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: There is a reasonable possibility that the events headache and ocular hyperemia were related to COMIRNATY (2024-2025 FORMULA) based on known drug safety profile. Based on the close temporal relationship, the association between the rest of the other events with COMIRNATY (2024-2025 FORMULA) can not be fully 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.
Test Date: 20241128; Test Name: eye pressure; Result Unstructured Data: Test Result:high