Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
early third dose; Potential 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 66-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Previously administered products included Hepatitis A-B combo vaccine (Received 1st dose of Hepatitis A-B combo vaccine on 26-JUL-2023). On 13-SEP-2024, the patient received the 2nd dose of Twinrix. On 11-OCT-2024, the patient received the 3rd dose of Twinrix. On 13-SEP-2024, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Potential late second dose). On 11-OCT-2024, the patient experienced drug dose administration interval too short (Verbatim: early third dose). The outcome of the drug dose administration interval too long and drug dose administration interval too short 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: 11-APR-2025 Pharmacist stated that a patient got what they thought it was a first dose of Twinrix on 13 September 2024 and second dose on 11 October 2024. But later they discovered that patient forgot that they received a prior dose of a Hepatitis A-B combo vaccine (unknown brand or lot number) on 26JUL2023 which led to drug dose administration interval too long and drug dose administration interval too short. The reporter did not have lot number or expiration date for none of the 2 Twinrix vaccines. Consented to follow up.; Sender's Comments: US-GSK-US2025038452:SAME REPORTER