Received Aug 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
lost 10 pounds; I could not eat; Suspected vaccination failure; Shingles in ear, hair and neck/face; Shigles in mouth; 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. In NOV-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: Shingles in ear, hair and neck/face) and oral herpes zoster (Verbatim: Shigles in mouth). On an unknown date, the patient experienced weight loss (Verbatim: lost 10 pounds) and eating disorder (Verbatim: I could not eat). The outcome of the vaccination failure, herpes zoster, oral herpes zoster, weight loss and eating disorder were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster, oral herpes zoster, weight loss and eating disorder 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 herpes zoster, oral herpes zoster, weight loss and eating disorder to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-AUG-2025 This case was reported by a patient via interactive digital media. Patient had gotten shingles last year, from early November through December. It affected his/her ear, mouth, hair, neck, and face. The only thing that got his/her through was Jesus. The pain had been awful, even though he/she had received the shingles vaccine. Patient had gone to the physician and hospital, but only my physician assistant had helped. Patient had lost 10 pounds because he/she could not eat. 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 Shingles vaccine.