Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | T5P73 | — |
Maladministration of Adult Dose on an Pediatric Patient; Adult Dose on an Pediatric Patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 17-year-old female patient who received HBV (Engerix B) (batch number T5P73, expiry date 10-APR-2027) for prophylaxis. On 20-MAR-2025, the patient received Engerix B. On 20-MAR-2025, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: Maladministration of Adult Dose on an Pediatric Patient) and overdose (Verbatim: Adult Dose on an Pediatric Patient). The outcome of the adult product administered to child 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: 28-APR-2025 The pharmacist called to ask about guidance/safety concerns because a pediatric patient seventeen year old was administered with an adult dose, which led to adult product administered to child and overdose. The Vaccine Administration Facility is the same as Primary Reporter.