Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; the rash during the outbreak to heal or minimize the discomfort/ rashes still keep coming; Discomfort; 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 (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: the rash during the outbreak to heal or minimize the discomfort/ rashes still keep coming) and discomfort (Verbatim: Discomfort). The outcome of the vaccination failure, shingles and discomfort were not reported. It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles and discomfort to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via Interactive digital media. The patient mentioned that he/she had the Herpes Zoster vaccine but the rashes still keep coming. The patient enquired what they could do to the rash during the outbreak to heal or minimize the discomfort. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Herpes Zoster vaccine.