Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Shingles/on my back, right side and stomach so much pain; 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 chickenpox (had chix pox twice as a kid) and shingles (shingles at 25). On an unknown date, the patient received Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/on my back, right side and stomach so much pain). The patient was treated with gabapentin. 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: 06-APR-2025 This case was reported by a patient via interactive digital media. Patient had chicken pox twice as a kid, shingles at 25. Patient got the vaccine at 55. Patient was 57 at the time of reporting and got shingles about 2 weeks ago, on back, right side and stomach. Patient stated that so much pain was there. Gabapentin was the only thing that takes the edge of pain off. Reporter stated that Shingles was no joke. The spots were started to scab but still so much pain. Patient was not sure how much the vaccine helped. Maybe it would have been worse without the vaccine, can't even imagine. 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 is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Medical History/Concurrent Conditions: Chickenpox (had chix pox twice as a kid); Shingles (shingles at 25)