Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Suspected vaccination failure; Shingles after Shingrix; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles after 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. 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. Additional Information: GSK Receipt Date: 03-NOV-2025 and 04-NOV-2025 The reporter mentioned that for an immunocompromised patient 50 plus years of age who had received Shingrix (not Zostavax) over 4 years ago, and who had recently developed shingles and was still immunocompromised The reporter enquired whether it was recommended to be revaccinated with Shingrix. 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 The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving a dose of Shingrix in a subject. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Immunocompromised