Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; just got Shingles Mild on top of my head; 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 VARICELLA ZOSTER VACCINE for prophylaxis and VARICELLA ZOSTER VACCINE for prophylaxis. On an unknown date, the patient received Shingles vaccine, the 2nd dose of VARICELLA ZOSTER VACCINE and the 1st dose of VARICELLA ZOSTER VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, VARICELLA ZOSTER VACCINE and VARICELLA ZOSTER VACCINE, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: just got Shingles Mild on top of my head). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure 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 shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient got 2 shot in 2019 and improved version in 2023. The patient got Shingles mild on top of the head. The doctor said that it would have been worse if he/she would not vaccinated. It was reported as ten percent patients could get even vaccinated. The reporter was one of them. It was unknown if the reporter considered the vaccination failure and shingles to be related to Varicella zoster vaccine. 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 time to onset and laboratory confirmation of disease) is considered unrelated to Shingles vaccine.