Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 6 | 7NX57 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 5 | 4D333 | — |
Engerix-B - Extra doses; Engerix-B - Extra doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received HBV (Engerix B) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 4D333, expiry date 14-AUG-2026) for prophylaxis. On 04-MAR-2025, the patient received the 6th dose of Engerix B. On 15-NOV-2024, the patient received the 5th dose of Engerix B. On 15-NOV-2024, not applicable after receiving Engerix B and 365 days after receiving Engerix B, the patient experienced extra dose administered (Verbatim: Engerix-B - Extra doses). On 04-MAR-2025, the patient experienced extra dose administered (Verbatim: Engerix-B - Extra doses). The outcome of the extra dose administered 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: 05-MAR-2025 The health care provider reported that a patient received a fifth and sixth dose of Engerix-B, which led to extra dose administered. The patient received three doses in but due to lack of records this patient received a fifth and a sixth dose. The patient was currently 5 years 11-month-old. The fifth dose was administered on 11/15/2024 and the sixth dose was given on 3/4/2025.