Received May 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; had shingles twice in 3 months; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 99-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included nerve pain. Concomitant products included gabapentin. On 16-APR-2019, the patient received the 2nd dose of Shingrix. On 24-OCT-2018, the patient received the 1st dose of Shingrix. On 20-DEC-2025, 2440 days after receiving Shingrix and 2614 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles twice in 3 months). On 14-APR-2026, the outcome of the shingles was resolved (duration 3 months 25 days). The outcome of the vaccination failure was not reported. 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: 23-APR-2026 The reporter stated health nurse said to wait 10 years to get a booster for Shingrix. Her vaccines were in 2018 and 2019. However, the winter sucked she had shingles ended up in the emergency room twice. The reporter asked at 99 after 7 plus years can she get a booster maybe a 3rd shot or does she really have to wait for 10 years. The batch number was not provided upon follow up with the reporter.; Sender's Comments: A case of Vaccination failure, 2440 days after vaccination with the 2nd dose of Shingrix and 2614 days after vaccination with the 1st dosed of Shingrix, in a 99-year-old female patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
Nerve pain
GABAPENTIN