Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Possible Twinrix second dose administration out of the recommended time interval; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 04-JUN-2025, the patient received the 2nd dose of Twinrix. On 04-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Possible Twinrix second dose administration out of the recommended time interval). 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: 05-JUN-2025 The patient called to asked if it was okay that she "went up high, from the bottom line to almost the top" in a certain liver test (she couldn't recall which specific measurement) after receiving Twinrix as a second dose. Although she mentioned that she was "feeling okay." The patient received 2nd dose of Twinrix B, later than the recommended interval, which led to lengthening of vaccination schedule.
TWINRIX
Test Name: Liver function tests; Result Unstructured Data: (Test Result:went up high,Unit:unknown,Normal Low:,Normal High:); Comments: went up high, from the bottom line to almost the top; Comments: LabComments: Liver function tests : went up high, from the bottom line to almost the top