Received Jun 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Patient received 4th dose; Second dose: Jan 29 2025 Third dose: Feb 26 2025; First Dose: Sept 03 2024 Second dose: Jan 29 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. Previously administered products included Engerix b (received 1st dose on 03-SEP-2024). On 29-MAY-2025, the patient received the 4th dose of Engerix B. On 26-FEB-2025, the patient received the 3rd dose of Engerix B. On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: First Dose: Sept 03 2024 Second dose: Jan 29 2025). On 26-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: Second dose: Jan 29 2025 Third dose: Feb 26 2025). On 29-MAY-2025, the patient experienced extra dose administered (Verbatim: Patient received 4th dose). The outcome of the extra dose administered, drug dose administration interval too short 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: 09-JUN-2025 A registered nurse reported that the patient received their first dose of Engerix B on 3rd September 2024, their second dose on 29th January 2025, the third dose on 25th February 2025 and the fourth dose on 29th May 2025. The nurse initially stated they wanted data about the administration of a vaccine because the intervals were shorter than recommended. They also stated the need to test for titers. The Vaccine Administration Facility was the same as Primary Reporter The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule. The patient received 4th dose of Engerix B not as per local schedule, which led to extra dose administered.; Sender's Comments: US-GSK-US2025071733:same reporter