Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; still got shingles recently; and still had some nerve pain in shoulder, neck and the back of my head; 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: still got shingles recently) and post herpetic neuralgia (Verbatim: and still had some nerve pain in shoulder, neck and the back of my head). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got the vaccine and still got shingles recently. Reporter reported didn't had a lot of blisters but the pain was horrible and still had some nerve pain in shoulder, neck and the back of my head. 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. The follow-up could not be possible as no contact details were available.; 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.