Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | AZ2A3 | — |
Patient tested positive to hepatitis one day after getting Twinrix second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of hepatitis viral test positive in a 86-year-old male patient who received HAB (Twinrix) (batch number AZ2A3, expiry date 05-FEB-2028) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 24-JUL-2025, the patient received the 2nd dose of Twinrix. On 25-JUL-2025, 1 days after receiving Twinrix, the patient experienced hepatitis viral test positive (Verbatim: Patient tested positive to hepatitis one day after getting Twinrix second dose). The outcome of the hepatitis viral test positive was unknown. The reporter considered the hepatitis viral test positive to be possibly related to Twinrix and Twinrix Pre-Filled Syringe Device. The company considered the hepatitis viral test positive to be possibly related to Twinrix and Twinrix Pre-Filled Syringe Device. 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-AUG-2025 Pharmacist explained that a patient got Twinrix first dose on 16 Jul 2025 and second dose on 24 Jul 2025. Next day after having second dose, patient went to donate blood and they tested positive to hepatitis (unknown antigen). Later, patient's doctor run another blood test and the result was negative for Hepatitis (unknown antigen). They think the results from first test where due to the Twinrix vaccine.
Test Name: Hepatitis viral test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250725; Test Name: Hepatitis viral test; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:)