Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; Patient had shingles 5 times; The first of September was the last time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On 01-SEP-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: The first of September was the last time). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient had shingles 5 times). The outcome of the vaccination failure was not reported and the outcome of the shingles and shingles were unknown. The reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 22-SEP-2025 This case was reported by a patient via interactive digital media. Patient had shingles 5 times and the first of September was the last time. Patient had a severe reaction to the shingle shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingrix, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.