Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; 5th outbreak; i am 45 years; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 45-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, more than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: 5th outbreak) and inappropriate age at vaccine administration (Verbatim: i am 45 years). The outcome of the vaccination failure and shingles were not reported and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. Additional Information: GSK receipt date: 22-MAY-2026 This case was reported by a patient via interactive digital media. The patient took Shingrix two years ago and had fifth outbreak of Shingles. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than a year after receiving Shingrix, in a 45-year-old patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.