Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4T93R | — |
adult dose of Harvix to a 19-Month-Old pediatric patient; adult dose of Harvix to a 19-Month-Old pediatric patient; patient received 3 doses of Harvix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 18-month-old patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. Previously administered products included Havrix (Upon review two other doses were also given (1st on unknown date)) and Havrix (Upon review two other doses were also given (2nd on unknown date)). On 20-JUN-2025, the patient received Havrix 1440 adult. On 20-JUN-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: adult dose of Harvix to a 19-Month-Old pediatric patient), overdose (Verbatim: adult dose of Harvix to a 19-Month-Old pediatric patient) and extra dose administered (Verbatim: patient received 3 doses of Harvix). The outcome of the adult product administered to child, overdose 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 Other HCP reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old) 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. Upon review two other doses were also given. This case is 1 of 3 cases reported by same reporter.; Sender's Comments: US-GSK-US2025087636:Same reporter/Diffrent patient GSK-US2025087634:Same reporter/Diffrent patient