Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Just got diagnosed today with shingles under the breast; 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 (had Shingles under the breast in 2003). In OCT-2024, the patient received Shingles vaccine. On 02-AUG-2025, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Just got diagnosed today with shingles under the breast). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure 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 to be related to Shingles vaccine. Additional Information: GSK receipt date: 02-AUG-2025 This case was reported by a patient via interactive digital media. The patient just got diagnosed today with shingles on 02nd August 2025. The patient had shingles in 2003. The patient took the shot in October 2024. The patient guesses that anything can happen. The patient used oatmeal boiled in milk last time to put over it and it helped with pain. So, the patient will do it again. The patient wished that everyone who suffers with it experiences less pain. The patient had shingles in same place as last time under the breast. 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 information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Medical History/Concurrent Conditions: Shingles (had Shingles under the breast in 2003)