Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | H3N97 | — |
pediatric dose of Havrix instead of an adult dose; Pediatric dose administered instead of an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number H3N97, expiry date 01-JAN-2027) for prophylaxis. Previously administered products included Havrix pediatric (1st dose received on 5th December 2024). On 05-JUN-2025, the patient received Havrix pediatric. On 05-JUN-2025, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: pediatric dose of Havrix instead of an adult dose) and adult use of a child product (Verbatim: Pediatric dose administered instead of an adult dose). The outcome of the underdose and adult use of a child product 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: 05-JUN-2025 Registered Nurse explained that a 19 year old patient received a pediatric dose of Havrix instead of an adult dose today on June 5th, 2025, which led to ult use of a child product and underdose. Patient received first pediatric dose of Havrix on December 5th, 2024. The caller did not have lot number or expiration date for the first dose.