Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | LA |
Angioedema of sites of dermal filler placement. Filler was injected in July 2024; This spontaneous report was received from a consumer or other non-health professional, via other company, and refers to a 24-year-old not pregnancy female patient. The patient's medical history included dermal filler placement in July 2024. The patient's concurrent conditions included ulcerative colitis, and allergy to penicillin and minocycline. Historical drugs included penicillin and minocycline. Concomitant therapies were not reported. On 25-NOV-2025, the patient received the dose #2 of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (GARDASIL) administered as prophylaxis in Left Arm (dose, vaccine scheme, rout of administration were not reported; expiration date and lot # were not available/provided to reporter at the time of report); also on the same date at 6:30 pm, she was vaccinated with 2025 Covid Booster (dose, vaccine scheme, rout of administration were not reported; expiration date and lot # were not available/provided to reporter at the time of report). Facility was reported as pharmacy/drugstore. It was added that the patient did not receive any other vaccines within 4 weeks prior to the above reported vaccines. On 27-NOV-2025, the patient experienced angioedema of sites of dermal filler placement. Filler was injected in July 2024 (historical condition). The patient was not taking any other medications within 2 weeks of the event starting. On 28-NOV-2025, she received corticosteroid and antihistamines via intravenous (IV) as treatment for the event. At the reporting time, the patient was recovering from the event. The causal relationship between the event and suspect vaccines was not provided. Upon internal review, the event of angioedema of sites of dermal filler placement was determined to be medically significant.
Drug allergy; Ulcerative colitis
Medical History/Concurrent Conditions: Dermal filler injection