Received Jun 18, 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 | — | — |
the fourth dose in May 29, 2025.; second dose in January 29, 2025, the third dose in February 25, 2025; first dose in September 3, 2025, their second dose in January 29, 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old female 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 25-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 in September 3, 2025, their second dose in January 29, 2025). On 25-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: second dose in January 29, 2025, the third dose in February 25, 2025). On 29-MAY-2025, the patient experienced extra dose administered (Verbatim: the fourth dose in May 29, 2025.). The outcome of the drug dose administration interval too long, drug dose administration interval too short and extra dose administered 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-US2025071746:same reporter