Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
abscess at injection site; This is a solicited report received from an Other HCP, Program ID. An 87-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Nov2024 at 12:31 as dose 1, single (Batch/Lot number: unknown) at the age of 87 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ABSCESS (medically significant) with onset 11Nov2024 at 09:00, outcome "unknown", described as "abscess at injection site". Patient was noticed an abscess at injection site. She was reported white pus coming from abscess. She was a nurse so she took care of cleaning and draining it. She didn't get seen by a doctor for it. Causality for "abscess at injection site" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction). The reporter's assessment of the causal relationship of "abscess at injection site" 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. Amendment: This follow-up report is being submitted to amend previous information: device causality assessment and reaction data (event "abscess at injection site" was upgraded to serious as medically significant).; Sender's Comments: Based on plausible temporal association and limited information available, there is reasonable possibility of causal association between the event abscess at injection site and the suspect drug BNT162b2 omicron (kp.2).