Received May 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Approx 3-4 weeks after receiving Comirnaty at store he experienced unilateral ptosis in his right eye.; This is a spontaneous report received from a Physician from a sales representative. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2025 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYELID PTOSIS (medically significant) with onset 02Nov2025, outcome "not recovered", described as "Approx 3-4 weeks after receiving Comirnaty at store he experienced unilateral ptosis in his right eye.". It was unknown if therapeutic measures were taken as a result of eyelid ptosis. Additional information: Facility where vaccine was administered at Pharmacy or Drug Store. It was mentioned as unknown whether patient received any other vaccines on the same date as the vaccine(s). It was mentioned as unknown whether patient receive any other vaccines within 4 weeks Prior to the vaccine(s). Approx 3 to 4 weeks after receiving Comirnaty at store he experienced unilateral ptosis in his right eye. His eye remained completely closed for 10 days. He was still experiencing some symptoms related to the ptosis. This reaction occurred on or around 02Nov2025. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on the available information the company considers that there was not a reasonable possibility that the event Ptosis was related to BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA). There is no compelling evidence to implicate suspect drug with the event nd more likely related to underlying/intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer drug 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