Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | LA |
Angioedema of sites of dermal filler placement; Angioedema of sites of dermal filler placement; This is a spontaneous report received from a Consumer or other non HCP. A 24-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Nov2025 at 18:30 as dose 1, single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation; hpv vaccine vlp rl1 4v (yeast) (GARDASIL), on 25Nov2025 as dose 2, single, in left arm for immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing); "dermal filler", start date: Jul2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Minocycline, reaction(s): "Allergies: minocycline". The following information was reported: ANGIOEDEMA (medically significant), DERMAL FILLER REACTION (medically significant) all with onset 27Nov2025 at 14:00, outcome "recovering" and all described as "Angioedema of sites of dermal filler placement". Therapeutic measures were taken as a result of angioedema, dermal filler reaction. Clinical course: Angioedema of sites of dermal filler placement. Filler was injected in Jul2024. Treatment for the event was Corticosteroid and antihistamines via IV. No other vaccine in four weeks and no other medications in two weeks. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Dermal filler injection; Penicillin allergy; Ulcerative colitis