Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | K4JH7 | — |
adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose; adult patient was administered a pediatric dose of the Engerix-B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 64-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 14-JAN-2025, the patient received Engerix B pediatric. On 14-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose) and adult use of a child product (Verbatim: adult patient was administered a pediatric dose of the Engerix-B vaccine). The outcome of the accidental underdose and adult use of a child product were unknown. 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: 14-JAN-2025 The reporter called to report an adult patient was administered a pediatric dose of the Engerix-B vaccine, due to a hurry to give the patient a hepatitis-b dose, which led to an adult use of a child product and accidental underdose. Reporter asked about to advise whether to give another pediatric dose (and when) or when to administer an adult Engerix-B dose. The vaccine administration facility was the same as primary reporter.