Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Lack of drug effect; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 28-NOV-2020, the patient received the 2nd dose of Shingrix. On 27-SEP-2020, the patient received the 1st dose of Shingrix. In AUG-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 18-SEP-2025 The patient was currently getting over a case of shingles (lack of drug effect) which began approximately 3 weeks ago. The patient had no health concerned and was not taking any medication on a regular basis. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. No further information was obtained/provided; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving 1si dose of Shingrix and 2nd dose of Shingrix, in a 64-year-old 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.