Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 324BY | — |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
The patient has not received a second dose of Twinrix; received first dose of Havrix on 29Jan2019/first dose of Twinrix on 10Apr2025/Inappropriate schedule of vaccine administered; 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 65-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Previously administered products included Havrix (patient received the first dose of Havrix on 29-JAN-2019 Batch no: D94MK Exp date :05-JUL-2021). On 10-APR-2025, the patient received the 1st dose of Twinrix. The patient did not receive the 2nd dose of Twinrix. On 10-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Havrix on 29Jan2019/first dose of Twinrix on 10Apr2025/Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: The patient has not received a second dose of Twinrix). The outcome of the drug dose administration interval too long and incomplete course of vaccination were 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: 17-JUL-2025 A patient received the first dose of Havrix and Twinrix has not receive a second dose. The patient received a dose of Havrix and then received a dose of Twinrix as a booster of Havrix (Hepatitis A) later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.