Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; Some time later developed Shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Some time later developed Shingles). 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 Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date :29-MAY-2025 Nurse reported that patient was fully vaccinated with shingrix vaccines, 2 doses as indicated. She did not have dates of 1st or 2nd doses given. Some time later developed shingles. No additional information was provided regarding events at time of receiving 1st or 2nd dose. Shingles was believed to had developed in January 2025 exact dates not provided when did this happened. This case was considered as suspected vaccination failure as details regarding 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).