Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | — |
Delayed inflammatory reaction to hyaluronic acid filler following COVID-19 vaccination; Swelling of the lips and the bilateral under eye compartments/Inflammation around her eyes; Swelling of the lips and the bilateral under eye compartments/Inflammation around her eyes; Swelling of the lips and the bilateral under eye compartments/Inflammation around her eyes; This is a literature report for the following literature source(s). A 29-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single and as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INFLAMMATION (medically significant), outcome "recovered", described as "Delayed inflammatory reaction to hyaluronic acid filler following COVID-19 vaccination"; LIP SWELLING (medically significant), PERIORBITAL SWELLING (medically significant), DERMATITIS (medically significant), outcome "recovered" and all described as "Swelling of the lips and the bilateral under eye compartments/Inflammation around her eyes". Therapeutic measures were taken as a result of inflammation, lip swelling, periorbital swelling, dermatitis. Clinical course: Duration of filler was 4 months, Type of vaccine was "1st dose of Pfizer after 2 doses of Moderna". Clinical features were swelling of the lips and the bilateral under-eye compartments. Treatment included watchful waiting; Hyaluronidase injection (under-eye). Treatment response: Lip swelling had resolved but the inflammation around her eyes persisted; completely resolution in 1 day.; Sender's Comments: Based on the temporal relationship, the association between the event inflammatory reaction with BNT162b2 can not be fully excluded. There is a reasonable possibility that the events lip swelling, periorbital swelling, and dermatitis were related to BNT162b2 based on known drug safety profile. 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.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none