Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 255T2 | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Vaccination failure; Shingles; Patient is less than 60; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 59-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255T2) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis. On 27-AUG-2025, the patient received the 1st dose of Arexvy (left arm). In NOV-2019, the patient received the 2nd dose of Shingrix. In AUG-2019, the patient received the 1st dose of Shingrix. On 27-AUG-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient is less than 60). On 05-SEP-2025, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with valaciclovir hydrochloride (Valacyclovir Hcl). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the shingles to be related to Arexvy, Shingrix and Shingrix. It was unknown if the reporter considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Arexvy, Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-SEP-2025 It was reported that Shingles appeared just over a week after the patient received the RSV vaccination, which could have been coincidental. The patient mentioned that this timing might have been a coincidence, as the RSV vaccine was administered and, just over a week later, a Shingles outbreak occurred. The patient had previously received the Shingrix vaccine (first dose in August 2019; second dose in November 2019), which had definitely reduced the severity of the Shingles outbreak. However, the patient was unsure if the RSV vaccination had triggered the event and thought it was worth reporting.; Sender's Comments: A case of Vaccination failure, 9 days after receiving 1st dose of Arexvy and 2nd dose of Shingrix, in a 59-year-old female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received