Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | Y5X9T | IM |
Wrong schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 79-year-old female patient who received HBV (Engerix B adult) (batch number Y5X9T, expiry date 30-SEP-2026) for prophylaxis. Previously administered products included Engerix b adulto (received 1st dose on 22 Nov 2024) and Engerix b adulto (received 2nd dose on20 DEC 2024). On 14-APR-2025, the patient received Engerix B adult (intramuscular). On 14-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short (Verbatim: Wrong schedule). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 16-APR-2025 The reporter was the patient who received her 3rd dose of Engerix-B outside of the prescribing information recommended schedule. Persons 20 years of age and older had a series of 3 doses (1 mL each) on a 0, 1, 6 month schedule. The patient was given doses on these dates, first dose on 22nd November 2024, second dose on 20th December 2024, and third dose on 14th April 2025. The patient did ask about efficacy of vaccine off schedule and recommendations. The reporter did not fit into any of the special populations listed in the PI. MI information was given for her physician reference. The patient received the 3rd dose of Engerix b adult esrlier than the recommended interval, which led to shortenings of vaccine schedule.