Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Inappropriate Dose Administered (adult dose maladministered on a pediatric patient); Inappropriate Dose Administered (adult dose maladministered on a pediatric patient); This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a patient who received HAV (Havrix 1440 adult) for prophylaxis. On an unknown date, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: Inappropriate Dose Administered (adult dose maladministered on a pediatric patient)) and adult product administered to child (Verbatim: Inappropriate Dose Administered (adult dose maladministered on a pediatric patient)). The outcome of the accidental 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: 06-MAR-2025 The reporter called to ask any medical concerns about the maladministration of an adult dose in a pediatric patient on one of their clinics, which led to accidental overdose and adult product administered to child. No vaccination date, nor vaccine detail or patient´s demographics were obtained (Anonymous Healthcare provider did not consent follow-up from Safety Department). No further information was obtained in this call. Did not consent to follow-up.