Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
endocarditis; chest burning; fatigue; muscle pain; anxiety; This serious case was reported by a physician via call center representative and described the occurrence of endocarditis in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza 2024-2025 Vaccine) for prophylaxis. In JUL-2025, the patient received Shingrix and the 1st dose of Influenza 2024-2025 Vaccine. In AUG-2025, less than a month after receiving Shingrix and Influenza 2024-2025 Vaccine, the patient experienced fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle pain) and anxiety (Verbatim: anxiety). On an unknown date, the patient experienced endocarditis (Verbatim: endocarditis) (serious criteria GSK medically significant) and chest burning (Verbatim: chest burning). The patient was treated with prednisone. In AUG-2025, the outcome of the chest burning was resolved. The outcome of the endocarditis, fatigue, muscle pain and anxiety were not reported. It was unknown if the reporter considered the endocarditis, chest burning, fatigue, muscle pain and anxiety to be related to Shingrix and Influenza 2024-2025 Vaccine. The company considered the endocarditis to be unrelated to Shingrix and Influenza 2024-2025 Vaccine. It was unknown if the company considered the chest burning, fatigue, muscle pain and anxiety to be related to Shingrix and Influenza 2024-2025 Vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 The physician called to inform that was administered the Flu vaccine (was not sure if it was Fluarix or Flulaval) and Shingrix together. After this the patient started developing chest burning and was admitted at the emergency room, where no arrythmias were found but endocarditis was not ruled out. Then, the patient was prescribed with prednisone for 1 week. After 10 days she discontinued the therapy and the chest burning symptoms were resolved but she started developing fatigue, muscle pain and anxiety. The physician called to get guidance after this episode, and they need clarification if something else needs to be done. Date of administration of both vaccines was sometime between 29 and 30 July 2025.; Sender's Comments: A case of Endocarditis, less than a month after receiving Shingrix and Influenza 2024-2025 Vaccine, in a 63-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.