Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; Break through case; residual PHN; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. 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), shingles (Verbatim: Break through case) and post herpetic neuralgia (Verbatim: residual PHN). The outcome of the vaccination failure was resolving and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. It was unknown if the company considered the post herpetic neuralgia to be related to Shingrix. Additional Information: GSK Receipt Date: 14-MAY-2025 The patient had been approximately 70 years old. The patient received subsequent dose of the Shingrix vaccine and experienced vaccine failure which was ongoing but in recovering state and it was not serious. It had been a breakthrough case (shingles), but very mild. The patient had been prescribed antivirals right away but had still experienced 2/10 pain and some residual postherpetic neuralgia (PHN). No other products received by the patient. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix