Received Apr 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
both vaccinations in the series 3 weeks apart; Suspected vaccination failure; I had a breakthrough of disease/shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In MAR-2026, 7 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had a breakthrough of disease/shingles). On an unknown date, the patient experienced drug dose administration interval too short (Verbatim: both vaccinations in the series 3 weeks apart). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too short was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 31-MAR-2026 Patient received Shingrix both vaccinations I the series 3 weeks apart, 7 years ago at the age of 50 and had strong response then but past weekend before reporting had a breakthrough of disease. Also stated that the shingles developed on Friday night on neck in a line so patient went to doctor urgent care, Saturday morning doctor confirmed diagnosis and stared Valacyclovir that day. On the day of reporting patient continued to have new lesions affecting C2, C3, C4 and V3 dermatomes and was hoping to not crossover into any other areas closer to eyes. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Vaccination failure, 7 years after vaccination with the 2nd dose of Shingrix and the 1st dose of Shingrix, in a 57-year-old patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.