Received Oct 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0738 | — |
Chronic Spontaneous Angioedema with tongue, lips, throat, nasal swelling; Chronic Spontaneous Angioedema with tongue, lips, throat, nasal swelling; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, single (Lot number: NA0738), in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE, start date: 2025; BABY ASPIRIN, start date: 2025; ROSUVASTATIN, start date: 2025; FAMOTIDINE, start date: 2025; OZEMPIC, start date: 2025. The following information was reported: ANGIOEDEMA (medically significant), TONGUE OEDEMA (non-serious) all with onset 20Sep2025, outcome "recovering" and all described as "Chronic Spontaneous Angioedema with tongue, lips, throat, nasal swelling". Therapeutic measures were taken as a result of angioedema, tongue oedema. Clinical course: Patient not received other vaccine same date and not received ther vaccine in four weeks. Other medications in 2 weeks received included Omeprazole, Baby Aspirin, Rosuvastatin, Ozempic. Therapeutic measures for adverse events included High dose antihistamine and then Xolair. Patient had no known allergies. No follow-up attempts are possible.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
OMEPRAZOLE; BABY ASPIRIN; ROSUVASTATIN; FAMOTIDINE; OZEMPIC