Received May 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 2 | — | — |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | KD27Z | — |
Patient got Twinrix dose 1 on 4/9/2026 and Dose 2 Heplisav on 5/7/2026. Patient developed bradycardia; This non-serious case was reported by a other health professional via call center representative and described the occurrence of bradycardia in a adult female patient who received HAB (Twinrix) suspension for injection in pre-filled syringe (batch number KD27Z with expiry date 08-SEP-2028) for prophylaxis. Co-suspect products included HEPATITIS B VACCINE RHBSAG (YEAST) (HEPLISAV B) for prophylaxis. On 09-APR-2026, the patient received the 1st dose of Twinrix. On 07-MAY-2026, the patient received the 2nd dose of HEPLISAV B. In MAY-2026, an unknown time after receiving Twinrix and an unknown time after receiving HEPLISAV B, the patient experienced bradycardia (Verbatim: Patient got Twinrix dose 1 on 4/9/2026 and Dose 2 Heplisav on 5/7/2026. Patient developed bradycardia). The outcome of the bradycardia was unknown. The reporter considered the bradycardia to be unrelated to Twinrix and Twinrix Pre-Filled Syringe Device. The reporter considered the bradycardia to be not reported if related to HEPLISAV B. The company considered the bradycardia to be unrelated to Twinrix and Twinrix Pre-Filled Syringe Device. The company considered the bradycardia to be not reported if related to HEPLISAV B. 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: 22-MAY-2026 The patient developed bradycardia few days ago after dose 2 Heplisav.