Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Suspectd vaccination failure; Recurrent shingles episodes; Flu like symptoms; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female 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: Suspectd vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Recurrent shingles episodes) and influenza-like symptoms (Verbatim: Flu like symptoms). The patient was treated with valaciclovir. The outcome of the vaccination failure was not reported and the outcome of the shingles and influenza-like symptoms were unknown. It was unknown if the reporter considered the vaccination failure, shingles and influenza-like symptoms 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 and influenza-like symptoms to be related to Shingrix. Additional Information: GSK Receipt Date: 30-JAN-2025 The member of the public called and mentioning that the patient got a Shingrix shot four years ago and since the patient got it, the patient had recurrent rash for several times on body and flu like symptoms as well. The patient had been experiencing recurrent shingles. The patient doctor told that the patient could receive another shot six months after not been experiencing any shingles episode. And also has been giving the patient valaciclovir. The reporter asked could you give any advise, did the patient need to see an infectious disease specialist. The patient demographics were obtained in this call. No specific vaccination date nor vaccine details were provided from the member of the Public end. No other information was obtained in this call. This case was considered as suspected vaccination failure as details regarding completion of primary 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix .