Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | 9K34M | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 9K34M | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Late 3rd dose; Overdose; Late 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 long in a 46-year-old male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 9K34M) for prophylaxis and HBV (Engerix B) (batch number 9K34M) for prophylaxis. Previously administered products included Shingrix (received the 1st dose on 22-Oct-2013). On 03-SEP-2014, the patient received the 2nd dose of Engerix B. On 15-JUL-2024, the patient received the 3rd dose of Engerix B. On 15-JUL-2025, the patient received the 4th dose of Engerix B. On 03-SEP-2014, an unknown time after receiving Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 15-JUL-2025, the patient experienced drug dose administration interval too long (Verbatim: Late 3rd dose) and overdose (Verbatim: Overdose). The outcome of the drug dose administration interval too long, drug dose administration interval too long and overdose 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: 15-JUL-2025 Other HCP reported that they accidentally administered a 2nd dose of the Hep B (Engerix-B) vaccine to an adult in the same day. Reporter mentioned that the PX received the 1st dose on 22nd October 20213, and the 2nd on 03rd September 2014, which led to drug dose administration interval too long. And on 15th July 2024 the patient received the 3rd and 4th dose (on the same day), which led to drug dose administration interval too long and accidental overdose. The lot number that HCP provide was for the 3rd and 4th dose.