Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; Shingles after vaccination; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female 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. On an unknown date, 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: Shingles after vaccination). 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 Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK receipt date: 16-OCT-2025 Physician also stated that the long-term data has gone down. No further details were provided. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Vaccination failure and Herpes zoster, on an unknown time after receiving 1st dose of Shingrix and the 2nd dose of Shingrix, in a female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.