Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
I had it 5 years ago for 4 months. I've had the vaccine but I am experiencing a flare up now./suspected vaccination failure; Shingles/ experiencing flare up; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (the patient had shingles 5 years ago for 4 months). 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: I had it 5 years ago for 4 months. I've had the vaccine but I am experiencing a flare up now./suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ experiencing flare up). 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: 09-SEP-2025 This case was reported by a consumer via interactive digital media. The patient had shingles 5 years ago and received vaccine. But the patient now experiencing flare up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was unknown. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a adult female 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.
Medical History/Concurrent Conditions: Shingles (the patient had shingles 5 years ago for 4 months)