Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | P2443 | IM / LA |
pain at injection site; redness at the injection site; has pain when moving the arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis. On 13-JUN-2025, the patient received Twinrix (intramuscular use, left arm) 1 ml. In JUN-2025, an unknown time after receiving Twinrix, the patient experienced injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at the injection site) and pain in arm (Verbatim: has pain when moving the arm). The outcome of the injection site pain, injection site erythema and pain in arm were not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and pain in arm to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site erythema and pain in arm 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: 20-JUN-2025 The reporter was a healthcare professional. She reported on June 20th 2025 an adverse event for Twinrix vaccine. She reported that a male patient received a Twinrix vaccine at their pharmacy on June 13th, 2025. The vaccine was administered in the left arm. The patient contacted the pharmacy twice and reported an adverse event of pain at the injection site, (pain). The patient reported he had pain when moving the arm (painful when moving). The patient reported to healthcare professional that the redness at the injection site and stated it was the size of a dime. The healthcare professional reported that after a week the patient was still experienced these events and have not improved. No additional medical history or medications information were provided.