Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0589 | OT / RA |
Bad rash; This is a spontaneous report received from a Nurse. A 79-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 09Oct2025 as dose 1, single (Lot number: NA0589, Expiration Date: 23Jun2026) at the age of 79 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (ongoing), notes: Glaucoma; "Arthritis" (ongoing), notes: Arthritis; "hearing aid", start date: 2023 (ongoing), notes: hearing aid Has had 2.5 years. Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation, on 09Oct2025 as dose number unknown, single; TYLENOL oral taken for arthritis (ongoing); ALEVE oral taken for arthritis (ongoing); TIMOLOL ophthalmic taken for glaucoma (ongoing); LATANOPROST ophthalmic taken for glaucoma (ongoing). The following information was reported: RASH (medically significant) with onset 10Oct2025, outcome "not recovered", described as "Bad rash". Therapeutic measures were taken as a result of rash. Clinical course: Bad Rash she got the shot last Thursday, confirmed as, 09Oct2025. Then 24 hours got bad rash. Seriousness Criteria: Confirms as medically significant. The bad rash was completely surrounding the trunk of body. It was enough to call and report. The patient took all the anti-itch medications that are available at the drug store. Causality: 98% would say yes. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The AE did not require a visit to the Emergency Room. The AE did not require a visit to a Physician's Office. The patient previously received the Pfizer suspect vaccine. The patient was not allergic to any previous vaccination, medications, food or other products.; Sender's Comments: Based on the available information and product safety profile, a causal relationship between the reported serious event- ( Rash ) and suspect drug is assessed as possible. 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 event. 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.
Arthritis; Glaucoma; Hearing aid user (hearing aid Has had 2.5 years)
FLUZONE HIGH DOSE; TYLENOL; ALEVE; TIMOLOL; LATANOPROST