Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
am suffering with my second outbreak /both arms and left hip/ Some on my neck and under my chin; 1st was last September/ Then was right arm; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 1st was last September/ Then was right arm). On an unknown date, the patient experienced shingles (Verbatim: am suffering with my second outbreak /both arms and left hip/ Some on my neck and under my chin). The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles 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 and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated he/she also been vaccinated and was suffering with second outbreak. The patient had 1st in last September and then was right arm. The patient stated this time both arms and left hip and some on neck and under chin. The patient stated it was miserable and he/she will be 80 in a couple of weeks. The patient stated it was not the way wanted to celebrate his/her birthday This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.