Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; I am suffering now look like shingles; itchy feeling inside the skin everywhere in my body; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included diabetes. 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: I am suffering now look like shingles) and generalized pruritus (Verbatim: itchy feeling inside the skin everywhere in my body). The outcome of the vaccination failure was not reported and the outcome of the shingles and generalized pruritus were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and generalized pruritus 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 generalized pruritus to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-DEC-2025 The patient self-reported this case for herself/ himself. The patient had vaccination of Shingles 3 years ago (from the date of reporting) and he/she was suffering now (at the time of reporting), look like shingles (itchy feeling inside the skin everywhere in his/her body). The patient was concerned and unsure if this was actually shingles and wanted to receive advise on reported event. 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. The batch number was not provided and a request for this information had been made.; 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. Further follow up information has been sought.
Diabetes