Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; just got over shingles; They were uncomfortable; 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. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: just got over shingles) and discomfort (Verbatim: They were uncomfortable). The outcome of the vaccination failure was not reported and the outcome of the shingles and discomfort were resolved. It was unknown if the reporter considered the vaccination failure, shingles and discomfort 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 and discomfort to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-AUG-2025 This case was reported by a patient via interactive digital media. Patient got the shots about a year ago in 2024. Patient indicated that without having the Shingles shot, his /her getting them, patient would have suffered more. So, patient suggested to get the shot. 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, an 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.