Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | UNK | — |
Suspected vaccination failure; shingles outbreaks; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included varicella zoster vaccine live (oka/merck) (Zostavax) for prophylaxis. On an unknown date, the patient received Shingrix and Zostavax. On an unknown date, an unknown time after receiving Shingrix and an unknown time after starting Zostavax, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles outbreaks). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Zostavax. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Zostavax. It was unknown if the company considered the vaccination failure to be related to Zostavax. Additional Information: GSK Receipt Date: 07-AUG-2025 The reporter stated that her friend has had several shingles outbreaks since his vaccination. She does not know if it was Zostavax or Shingrix that he (patient) had. The reporter does not know if the patient had both doses of Shingrix vaccine. 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 and Zostavax vaccine.