Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Shingles; turning black looking; 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. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and skin discoloration (Verbatim: turning black looking). The outcome of the vaccination failure and skin discoloration were not reported, and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure, shingles and skin discoloration 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 and skin discoloration to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 10-NOV-2025 The case was received from the patient via interactive digital media. The patient reported having shingles for approximately one and a half weeks. During this period, the patient experienced unbearable pain, which was described as unlike any previous pain The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting; 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.