Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
liver transplant; This serious case was reported by a pharmacist via call center representative and described the occurrence of liver transplant in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis. Concurrent medical conditions included liver disorder. On 15-MAY-2025, the patient received Twinrix. On 16-MAY-2025, 1 days after receiving Twinrix, the patient experienced liver transplant (Verbatim: liver transplant) (serious criteria clinically significant/intervention required). The outcome of the liver transplant was not reported. It was unknown if the reporter considered the liver transplant to be related to Twinrix and Twinrix Pre-Filled Syringe Device. The company considered the liver transplant to be unrelated 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: 27-AUG-2025 The pharmacist contacted GlaxoSmithKline to request data about the recommendations after a patient received their first dose of Twinrix and the following day, got a liver transplant and then never got their second dose. The reporter wanted to know if there was any data, including recommendations. The reporter did not have the vaccine details. The vaccine administration facility was the same as primary reporter.; Sender's Comments: A case of Liver transplant, 1 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, in a 65-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative etiology (Concurrent medical conditions included liver disorder).
Liver disorder