Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; outbreak of shingles; postherpetic neuralgia; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles 10 years ago). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUL-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: outbreak of shingles) and post herpetic neuralgia (Verbatim: postherpetic neuralgia). The outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not reported. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 30-OCT-2025 On 30 October 2025 a Medical Doctor called to report a lack of efficacy for Shingrix. A female patient had shingles 10 years ago, then the patient had Shingrix on 2017 when it came available in the [withheld] and was their 1st dose. The patient completed the 2nd dose. On July, 2025 the patient had an outbreak of shingles with postherpetic neuralgia. Patient was not immunocompromised. This case was considered as suspected vaccination failure as details laboratory confirmation regarding 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 1st dose of Shingrix, in a 75-year-old female 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.
Medical History/Concurrent Conditions: Shingles (had shingles 10 years ago)