Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | AZ453 | — |
zero point five milliliter instead of one milliliter; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 48-year-old male patient who received HBV (Engerix B) (batch number AZ453, expiry date 12-FEB-2027) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 14-APR-2025, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: zero point five milliliter instead of one milliliter). The outcome of the underdose was 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: 15-APR-2025 The pharmacist called to report an adult patient that was administered half the dose that is 0.5 milliliter instead of 1 milliliter, which led to underdose. It had been 24 hours since the maladministered dose. The Vaccine Administration Facility is the same as Primary Reporter. 1st dose vaccination date was March 16th 2025 and 2nd dose vaccination date on April 14th 2025.
Engerix b