Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
swelling on left arm the size of a soft ball; burning sensation down to her elbow; sick; permanent memory loss; sores all over her body; Some sores would pop and leave scars; breathing issues; This is a spontaneous report received from an Other HCP, Program ID. A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Jun2025 at 01:05 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCAR (disability) with onset 10Jun2025, outcome "not recovered", described as "Some sores would pop and leave scars"; DYSPNOEA (disability) with onset 10Jun2025, outcome "not recovered", described as "breathing issues"; AMNESIA (disability) with onset 10Jun2025, outcome "unknown", described as "permanent memory loss"; SKIN LESION (disability) with onset 10Jun2025, outcome "not recovered", described as "sores all over her body"; VACCINATION SITE SWELLING (disability), outcome "unknown", described as "swelling on left arm the size of a soft ball"; VACCINATION SITE PAIN (disability), outcome "unknown", described as "burning sensation down to her elbow"; ILLNESS (disability), outcome "unknown", described as "sick". The events "permanent memory loss", "sores all over her body", "some sores would pop and leave scars", "breathing issues", "swelling on left arm the size of a soft ball", "burning sensation down to her elbow" and "sick" required physician office visit. Clinical course: The patient experienced swelling on left arm the size of a soft ball after receiving the vaccine. She also states there was a burning sensation down to her elbow. Patient became sick and went to visit her doctor. The patient then experienced sores all over her body. Some sores would pop and leave scars. The patient is still experiencing these sores. The patient states she has some permanent memory loss now and also has breathing issues. 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 temporal association, there is reasonable possibility of causal association between the Reported events Memory loss, Skin lesion, Scar, Breathing difficult, Vaccination site swelling, Vaccination site burning, Sickness and the suspect drug 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.