Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Overdose; 2 year old female given Havrix 1440 adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 2-year-old female patient who received HAV (Havrix 1440 adult) for prophylaxis. On 11-MAR-2025, the patient received the 1st dose of Havrix 1440 adult. On 11-MAR-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: 2 year old female given Havrix 1440 adult). The outcome of the overdose and adult product administered to child 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: 12-MAR-2025 The reporter reported that 2 year old female given Havrix 1440 EL.U/ml dose for 1st in Hepatitis A series on 11 MAR 2025 which led to Adult product administered to child and Overdose. They request to advise as pediatric patient received adult Havrix formulation. The vaccine administration facility was the same as primary reporter.