Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 324BY | — |
Late second dose - Inappropriate Schedule (wrong accelerated schedule); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 31-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 27-MAR-2025, the patient received the 2nd dose of Twinrix. On 27-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose - Inappropriate Schedule (wrong accelerated schedule)). The outcome of the drug dose administration interval too long 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: 28-MAR-2025 and 01-APR-2025 Registered Pharmacist asked for the following patient´s Twinrix schedule, when the third dose could be administered. The vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained from the Registered Pharmacist´s end. The reporter consented to follow up. The Vaccine administration Facility was the same as Primary Reporter. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Twinrix