Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Potential administration of Engerix-B 20 MGRS DOSE TO 19 YEAR-OLD PATIENTS; Potential administration of Engerix-B 20 MGRS DOSE TO 19 years old patinets; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B adult) for prophylaxis. On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Potential administration of Engerix-B 20 MGRS DOSE TO 19 YEAR-OLD PATIENTS) and adult product administered to child (Verbatim: Potential administration of Engerix-B 20 MGRS DOSE TO 19 years old patinets). The outcome of the overdose and adult product administered to child were not applicable. Additional Information: GSK Receipt Date:22-APR-2025 The reporter just noticed that Engerix-B 20 mgrs. dose was indicated for 20 years-old and older. She was not sure, but she believed that some 19 year-old patients could potentially receive Engerix-B 1 ml dose at her clinic, which led to overdose and adult product administered to child. She accepted a follow up to clarify. No further information available at the moment of the call. The Vaccine Administration Facility is the same as Primary Reporter. No further information available at the moment of the call. The reporter consented to follow up.