Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; Shingles 3 times in last 6 months after receiving both the doses of Shingrix; This serious case was reported by a pharmacist 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 Herpes zoster (Shingrix) for prophylaxis. On 04-NOV-2022, the patient received the 2nd dose of Shingrix. On 30-AUG-2022, the patient received 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 3 times in last 6 months after receiving both the doses of Shingrix). 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 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: 19-NOV-2025 The pharmacist reported that the completed both doses of Shingrix shots (3 months apart), but since contracted shingles three times in the last six months. The reporter was asking was there any data on an extra dose or if there was anything else could clinically recommend because of his frequency of outbreaks. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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, unknown time after receiving Shingrix (1st and 2nd dose), in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.