Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; shingle right now on my buttocks; 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. The patient's past medical history included shingles (had shingles 19 years ago). Concurrent medical conditions included fibromyalgia (has fibromyalgia) and degenerative disc disease (has degenerative disc disease). 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) and shingles (Verbatim: shingle right now on my buttocks). 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 Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-NOV-2025 This case was reported by a patient via interactive digital media. The patient reported being vaccinated with the shingles vaccine in 2019 and right now had shingles on the buttocks. The patient mentioned it was a literal pain in the butt. The patient stated that if the vaccine was supposed to make it not as bad, they would have hated to go through the pain without it, and the placement did not help either. The patient mentioned having fibromyalgia and degenerative disc disease, so living with pain daily was their norm. 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 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.
Degenerative disc disease (has degenerative disc disease); Fibromyalgia (has fibromyalgia)
Medical History/Concurrent Conditions: Shingles (had shingles 19 years ago)