Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Patient has 1st dose in Dec 2024, 2nd dose May 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose in December 2024). In MAY-2025, the patient received the 2nd dose of Twinrix. In MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Patient has 1st dose in Dec 2024, 2nd dose May 2025). The outcome of the drug dose administration interval too long was not applicable. 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: 29-JUL-2025 and 30-JUL-2025 The reporter reported that a patient was late for her second dose due to being out of the country. The HCP who originally called regarding medical information question in (withheld) case was different from Pharmacist who provided additional AE information upon callback from (withheld). This pharmacist's details who provided more information regarding AE are in AE form. The original HCP did not provide details regarding there being 2 patients. At this time, it was unknown if both patients had their doses on the same dates. Upon call back HCP who originally contacted (withheld) she states that both patients (husband and wife) got their 1st dose in Dec 2024, 2nd dose in May 2025. 3rd dose had not yet been administered. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case had been linked with US2025097730, reported by the same reporter; Sender's Comments: US-GSK-US2025097730:Same reporter/Diffrent patient