Received Jun 24, 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; shingles on his/her face; 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. 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) and facial herpes zoster (Verbatim: shingles on his/her face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-JUN-2025 This case was reported by a patient via interactive digital media. Patient had received both shots and was recovering from shingles on his/her face. It had been very frustrating and annoying trying to deal with them. It was everything they said it would be. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose) and Shingles (2nd dose) .