Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; I have a very light case of them on my thigh; 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) and shingles (Verbatim: I have a very light case of them on my thigh). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported got the shot at the required age of 60. He/she was thankful for that he/she did. They may had lowered the age now. Consumer reported his doctor thinks they had a very light case of them on thigh. Patient only had 2 spots. Patient got in the next day which started as nerve itching on the thigh. Consumer physician gave an antiviral medication the next day to the patient had symptoms. Consumer reported yes, he /she believes getting the shot and the medication, catching it early had decreased the symptoms and get the shot. Anyone that was suffering from severe pain she said t,hey prescribe gabapentin also which helps with the nerve pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 is an unlisted event which is considered unrelated to GSK Shingles vaccine."