Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; shingles was causing all this pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. In AUG-2025, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles was causing all this pain). 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 Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported by a patient via interactive digital media. The patient reported they had just got out of the hospital because it was hurting so bad and under ribs around back and thought they had pulled a muscle and maybe broke a rib. But later was turned-out to shingles which was causing all the pain which then broke out on back and underneath arm on left side. The patient had symptom, and was still going through it, it had been about 4 days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR116800, reported by same reporter for different patient.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Herpes Zoster vaccine, in a 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-US2025AMR116800:same reporter /different patient