Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
administer an Engerix-B vaccine and it was expired; Drug dose administration interval too long; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received HBV (Engerix B) (expiry date 09-MAR-2025) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Engerix-B (received the 1st dose of Engerix-B in 29-JUL-2024). On 18-MAR-2025, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, the patient received the 2nd dose of Engerix B. On 23-OCT-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 18-MAR-2025, the patient experienced expired vaccine used (Verbatim: administer an Engerix-B vaccine and it was expired). The outcome of the expired vaccine used and drug dose administration interval too long 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: 19-MAR-2025 On 19-Mar-2025 a Registered Nurse called and reported that had a medical assistant, before the day of reporting, who administered an Engerix-B vaccine and it was expired, it expired 09-Mar-2025. The Vaccine Administration Facility was the same as Primary Reporter. The vaccines was administered on 18-Mar-2025, the patient received prior Engerix-B doses on 29-July-2024 and 23-Oct-2024, which led to expired vaccine used and drug dose administration interval too long.