Received Aug 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix adult) for prophylaxis. On 20-JUN-2025, the patient received the 1st dose of Havrix adult. On 20-JUN-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)) and overdose (Verbatim: Maladministration of adult dose to a 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: 13-AUG-2025 The registered nurse called to ask about safety concerns on five patients vaccination schedule with the maladministration of an adult dose of Havrix which led to adult product administered to child and overdose. They just noticed due to a billing review. The registered nurse called in behalf of another site where the incident happened. Vaccination dates and partial patient demographics were obtained in this call. No vaccine detail was obtained in this call.