Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
Missing third dose; Late second dose; 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 54-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 24-NOV-2024, the patient received the 2nd dose of Twinrix. The patient did not receive the 3rd dose of Twinrix. On 24-NOV-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Missing third dose). 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: 07-AUG-2025 Pharmacist explained that he has a patient come in for vaccine, but she was off schedule and caller was wondering if they should repeat the series. According to Glaxo Smith Kline documentation, it supposed to be at 0, 1 month, 6 months. The patient received second dose at longer interval than recommended which led drug dose administration interval too long. They were requesting to come in and get their third dose today on 07-August-2025, what should been actually back in May, which led incomplete course of vaccination. It was unknown by the Pharmacist if the patient got any prior Hepatitis A or Hepatitis B vaccines. The reporter did not consent to follow-up.
Twinrix