Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected Vaccination failure; I have been going through a small outbreak for the last few weeks; Currently dealing with a lot of stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 84-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have been going through a small outbreak for the last few weeks) and stress (Verbatim: Currently dealing with a lot of stress). The outcome of the vaccination failure and shingles were not reported and the outcome of the stress was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and stress to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-JUN-2025 This case was reported by a patient via interactive digital media. Reporter was vaccinated twice for shingles but he/she had been going through a small outbreak for the last few weeks. Fortunately it did not seemed to be spreading. Reporter was 84 years old and currently dealing with a lot of stress. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)