Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
lack of vaccine effect/Suspected Vaccination failure; shingles/lesions that started on his right flank and spread to the right side of his back and his right abdomen along with stinging or burning pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old 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. In NOV-2020, the patient received the 1st dose of Shingrix. On 15-SEP-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: lack of vaccine effect/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/lesions that started on his right flank and spread to the right side of his back and his right abdomen along with stinging or burning pain). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure and shingles were 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: 25-SEP-2025 The patient received his first Shingrix dose in NOV 2020 and the second Shingrix dose within six months, in APR 2021 or MAY 2021. The patient saw his health care professional (HCP) on 22 SEP 2025 and that day, he started valacyclovir 1 gram three times a day for seven days. The patient had not yet noticed an improvement, but the lesions and pain have not worsened. Nothing else was reported. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: A case of Vaccination failure and Herpes zoster, between 2 and 3 months after receiving 2nd dose of Shingrix and between 3 and 5 months after receiving 1st dose of Shingrix, in a 73-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.