Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; broke out along the same nerve with red patches with little blisters/ it was shingles; Under stress; 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: broke out along the same nerve with red patches with little blisters/ it was shingles) and stress (Verbatim: Under stress). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure, shingles and stress were not reported. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine. The company considered the vaccination failure, shingles and stress to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient stated this had happened with him/her also. The patient had the Shingles vaccine and twice, under. Under stress, the patient broke out along the same nerve with red patches with little blisters. The patient's physician both times said it was shingles. Also gave him/her a prescription for Valtrex. The patient was really surprised that it broke through, but fortunately it was just an annoyance not an agony This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster and Stress are unlisted events which are considered unrelated to GSK Shingles vaccine."