Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; had shingles on leg near groin moving towards the back of his leg and was painful; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a elderly male 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. On 07-OCT-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles on leg near groin moving towards the back of his leg and was painful). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 14-OCT-2025 The reporter reported that the patient received both doses of Shingrix a while ago and shingles developed even after patient got previous vaccine. The patient had shingles on leg near groin moving towards the back of his leg and was painful. It was asked if patient had received Shingrix vs Zostavax then asked if patient received both doses. As far as they were told patient received both doses of Shingrix a while ago. The patient on antibiotics for symptoms but not sure about other medications patients may be on for other conditions. The batch number was not provided and a request for this information has been made. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingrix and the 1st dose of Shingrix, in a elderly male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.