Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspeceted vaccination failure; generally have recurrent outbreaks every; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: generally have recurrent outbreaks every). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure and herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter reported that for what it was worth, the vaccine was worth getting. Unfortunately, despite being vaccinated, the patient generally had recurrent outbreaks every 12-18 months. But thanks to that vaccine, his/her outbreak was very small, about the size of a half dollar. The patient had learned to always have a prescription for valacyclovir on hand so the reporter could start treatment the moment it started. Still painful and not fun but resolves within a few days. The patient could not imagine how bad it would be if the patient had not been vaccinated. This case was considered as suspected vaccination failure as details time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of shingles) is considered unrelated to GSK Shingles vaccine.