Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Shingles; I have no feeling on side where I had it bad; 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. The patient's past medical history included shingles (patient had it bad out of the blue, but once he/she got over it). 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: Shingles) and numbness (Verbatim: I have no feeling on side where I had it bad). The outcome of the vaccination failure, shingles and numbness were not reported. It was unknown if the reporter considered the vaccination failure, shingles and numbness to be related to Shingles vaccine. The company considered the vaccination failure, shingles and numbness to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media Patient had it bad out of the blue. Once he/she was over it, he/she got the shots and later ended up getting it again. The second time was at least mild. He/she lost feeling on the side where he/she had it bad. 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 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 Hypoaesthesia are unlisted events which are considered unrelated to GSK Shingles vaccine"
Medical History/Concurrent Conditions: Shingles (patient had it bad out of the blue, but once he/she got over it)