Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4T93R | — |
adult dose(Harvix) to a pediatric patient; adult dose(Harvix) to a pediatric patient; Upon review two other doses were also given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-year-old patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. On 23-MAY-2025, the patient received Havrix 1440 adult. On 23-MAY-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: adult dose(Harvix) to a pediatric patient), adult product administered to child (Verbatim: adult dose(Harvix) to a pediatric patient) and extra dose administered (Verbatim: Upon review two other doses were also given). The outcome of the overdose, adult product administered to child 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: 07-JUL-2025 The reporter reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old)and upon review two other doses were also given, which led to adult product administered to child and overdose and extra dose administered. Also asked if that dose was valid or not. Any side effects need to advise the parents of as well. This case was 1 of 3 cases reported by same reporter.; Sender's Comments: US-GSK-US2025085083:Same reporter/Diffrent patient US-GSK-US2025087636:Same reporter/Diffrent patient