Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Horrible sores in mouth; This non-serious case was reported by a consumer via sales rep and described the occurrence of sores mouth in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On 05-OCT-2025, the patient received the 2nd dose of Shingrix and Arexvy. On 05-OCT-2025, less than a day after receiving Shingrix and Arexvy, the patient experienced sores mouth (Verbatim: Horrible sores in mouth). The outcome of the sores mouth was unknown. The reporter considered the sores mouth to be related to Shingrix and Arexvy. The company considered the sores mouth to be related to Shingrix and Arexvy. Additional Information: GSK Receipt Date: 08-OCT-2025 A 50-year-old female received her second dose of Shingrix and one dose of Arexvy on the same day. Following the vaccinations, she reported experiencing severe mouth sores, which she believed were caused by the adjuvants present in both vaccines.