Received Apr 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 353S5 | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 524S7 | — |
Suspected vaccination failure; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 353S5) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 524S7) for prophylaxis. On 25-JAN-2019, the patient received the 2nd dose of Shingrix .5 ml. On 06-SEP-2018, the patient received the 1st dose of Shingrix .5 ml. On 18-MAR-2026, 2609 days after receiving Shingrix and 2750 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with valaciclovir (Valacyclovir). 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: 11-APR-2026 The patient self-reported this case for himself. The patient reported experiencing a very painful case of shingles for more than 3 weeks. He did receive a 10-day course of valacyclovir early in the disease. He was very healthy generally, and that was the first infectious disease of significance that he had in some years. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 2609 days after receiving 2nd dose of Shingrix and 2750 days after receiving 1st dose of Shingrix, in a 68-year-old male 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.