Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
suspected vaccination failure; Shingles; not sweating; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and valaciclovir hydrochloride (Valtrex) cream for shingles. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Valtrex. On an unknown date, less than a year after receiving Shingrix and Shingrix and not applicable after starting Valtrex, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and sweating decreased (Verbatim: not sweating). The action taken with Valtrex was unknown. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving and the outcome of the sweating decreased was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and sweating decreased to be related to Shingrix and Shingrix. It was unknown if the reporter considered the sweating decreased to be related to Valtrex. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and sweating decreased to be related to Shingrix and Shingrix. It was unknown if the company considered the sweating decreased to be related to Valtrex. Additional Information: GSK Receipt Date: 19-MAR-2025 The patient received 1st and 2nd dose of Shingrix vaccine in 2024 and was feeling fine. In 2024, the patient experienced Shingles. In 2025, the patient was not sweating. The reporter reported sweating as usual. Patient stated the health care professional prescribed her Valtrex for her Shingles, and she noticed after starting the Valtrex in 2025 that her body stopped sweating as usual. She had gone to 4 health care professional and wondered why this was happening and no one seems to answer. The reporter did not to release any health care professional name and numbers. This case was considered as suspected vaccination failure as details regarding 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and dose 2)
VALTREX