Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; believe shingles; burning and itchy rash; burning and itchy rash; 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 (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: believe shingles), itchy rash (Verbatim: burning and itchy rash) and burning sensation (Verbatim: burning and itchy rash). The outcome of the vaccination failure, shingles, itchy rash and burning sensation were not reported. It was unknown if the reporter considered the vaccination failure, shingles, itchy rash and burning sensation to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, itchy rash and burning sensation to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine but have had a rash this past week that was burning and itchy. The patient just came back from dermatologist, and they believed he/she had shingles. The patient was starting the treatment as he/she wrote this. 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.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles 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.