Received Sep 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
I had a moderate to severe case; I had a moderate to severe case; 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: I had a moderate to severe case) (serious criteria GSK medically significant) and shingles (Verbatim: I had a moderate to severe case). The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 1 month). 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: 19-AUG-2025 This case was reported by a patient via interactive digital media. Patient stated that if you do not get the 2nd dose the effectiveness is not high and vaccines can cause mild side effects but to him/her it was worth it to not get shingles. Also stated that Shingles are horrible and to treat it with anti-virals and meds to prevent nerve damage are expensive with no insurance. Patient was put on Valtrex and Gabapentin, as had a moderate to severe case and it lasts about 1 month to clear up. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.