Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
rash at injection site; itching; chill; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 25-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Patient received first dose on an unknown date) and Twinrix (Patient received second dose on an unknown date). On 24-FEB-2025, the patient received the 3rd dose of Twinrix. On 25-FEB-2025, 1 days after receiving Twinrix, the patient experienced injection site rash (Verbatim: rash at injection site), pruritus (Verbatim: itching), chills (Verbatim: chill) and fatigue (Verbatim: fatigue). On 26-FEB-2025, the outcome of the chills and fatigue were resolved (duration 1 day). The outcome of the injection site rash and pruritus were not resolved. It was unknown if the reporter considered the injection site rash, pruritus, chills and fatigue to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the injection site rash, pruritus, chills and fatigue to be 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: 26-FEB-2025 Patient who stated that from previous ones (Twinrix), he never had any issues but with his last vaccine for Twinrix, he started to develop a rash on his arm, and it was itching, and started having some other symptoms that he was kind of concerned about. Patient had a telehealth that night and he was told that everything was fine and he was okay. He received the vaccine on Monday, 24-FEB-2025, and Tuesday night when he got home around 7, he noticed he had a rash at the injection site (left shoulder), and chills. He stated he felt off throughout the day with fatigue and when asked if the symptoms had resolved, he stated the rash was still there, but the other symptoms were gone in the morning when he woke up.