Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4DS4N | — |
Angioedema; Irritation; Sore throat; This serious case was reported by a nurse via call center representative and described the occurrence of angioedema in a 65-year-old male patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis. Additional patient notes included no allergies. On 07-FEB-2025, the patient received Twinrix. On 10-FEB-2025, 3 days after receiving Twinrix, the patient experienced angioedema (Verbatim: Angioedema) (serious criteria GSK medically significant). In FEB-2025, the patient experienced irritability (Verbatim: Irritation) and sore throat (Verbatim: Sore throat). The patient was treated with prednisone. The outcome of the angioedema was not resolved and the outcome of the irritability and sore throat were resolving. It was unknown if the reporter considered the angioedema, irritability and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device. The company considered the angioedema to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the irritability and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-FEB-2025 Nurse called to report that patient received the Twinrix vaccine on 07 February 2025. The symptoms started on 10 February 2025 presented angioedema and he was seen in the office on 12 February 2025 with swollen mouth, Irritation, sore throat, dry lips, no fever but feeling warm. Patient was treated with prednisone 40mg for 5 days and symptoms went away for the most part but on 28 February 2025 at 3am it reoccurs, and patient presented lip and tongue swelling, jaw line was white and feels a pressure from the inside of his mouth. Nurse comments patient had no allergies at all that he knows of. Did not consent to follow-up. The vaccine administration facility is the same as primary reporter. No route for prednisone reported.; Sender's Comments: Angioedema is a listed event which is considered related to GSK vaccine Twinrix and Twinrix Pre-Filled Syringe Device.
Comments: no allergies