Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; shingles in my mouth; shingles in my cuticles and nail beds; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: shingles in my mouth) and shingles (Verbatim: shingles in my cuticles and nail beds). The outcome of the vaccination failure, oral herpes zoster and shingles were not reported. It was unknown if the reporter considered the vaccination failure, oral herpes zoster 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 oral herpes zoster and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a Patient via interactive digital media. Patient supposed the vaccine had worked for him/her. He/she had not had shingles on his/her body, but he/she had experienced it in his/her mouth, cuticles, and nail beds. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.