Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Late 2nd dose accelerated dosing/ diid not receive; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose accelerated dosing/ diid not receive). The outcome of the incomplete course of vaccination 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: 04-MAR-2025 Pharmacist called and reported that they had a patient who received a Twinrix dose on 10-Feb-2025 from batch number 429JJ with expiry date 01-APR-2026, she was going to be traveling to an area where it was a high or intermedia endemic for hepatitis. And so she had intentionally meant to do the accelerated dosing, however, reporter thought she got confused about when she received the doses, so she got one 10-Feb-2025, which was 22 days ago, today (on the day of reporting) she was going to get the 2nd one but it looks like she should receive the 2nd one about 2 weeks ago, 7 days after the 1st dose, and then she would receive the 3rd one today. So, reporter was wondering about, she would be traveling in June, so he/she was if it was possible for her, since she got the 1st dose in 10-Feb-2025, if she got her 2nd dose today, could she been getting a 3rd dose in you know 2 weeks to have accelerated dosing or not . During the call the reporter mentioned it seems this was the 1st Twinrix scheme dose for the patient, and, they did not have any records about the patient being immunocompromised. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to an incomplete course of vaccination.
TWINRIX