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 | — | — |
Early 3rd dose; Early 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Engerix b (patient received first dose on 17th October, 2024). On 06-MAR-2025, the patient received the 3rd dose of Engerix B. On 30-OCT-2024, the patient received the 2nd dose of Engerix B. On 30-OCT-2024, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). On 06-MAR-2025, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose). The outcome of the drug dose administration interval too short 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: 31-MAR-2025 Other HCP reported that a patient had received the series of Engerix-B with the schedule, 1st dose on 17th October 2024, 2nd dose on 30th October 2024 and 3rd dose on 6th March 2025. Reporter did not give more details about this and declined follow-up by safety team. The patient received 2nd dose of Engerix B,?earlier than the recommended interval, which led to shortening of vaccinations schedule. Patient received 3rd dose of Engerix B,?later than the recommended interval, which led to lengthening of vaccinations schedule.