Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
She is experiencing another bout with shingles now; I had this electric shock going on; Suspected vaccination failure/ lack of drug effect; Her first bout of shingles occurred 13 May 2024; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JAN-2022, the patient received the 2nd dose of Shingrix. On 26-SEP-2021, the patient received the 1st dose of Shingrix. On 13-MAY-2024, more than 2 years after receiving Shingrix and 960 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: Her first bout of shingles occurred 13 May 2024). On an unknown date, the patient experienced shingles (Verbatim: She is experiencing another bout with shingles now) and electric shock (Verbatim: I had this electric shock going on). The patient was treated with antivirals. The outcome of the vaccination failure, shingles and electric shock were not resolved and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure, shingles, shingles and electric shock 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, shingles and electric shock to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-SEP-2025 The patient is the reporter who received two doses of Shingrix and have had shingles twice. The patient's first bout of shingles occurred 6 months ago. She was experiencing another bout (2nd) with shingles now (at the time of reporting). She took antiviral both times. She also had quiet a reaction when she got the Shingrix shot so it was not like it did not work, she thought she developed a mild case of shingles when she had it, she had this electric shock going on. The reporter wanted to contact GlaxoSmithKline and to know what GSK could do about it. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked to the case US2025113050, reported by the same reporter.; Sender's Comments: A case of Vaccination failure, More than 2 years after receiving 2nd dose of 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. US-GSK-US2025113050:SAME REPORTER, DIFFERENT PATIENT