Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Lack of drug effect, diagnosed with shingles on right arm, suspected vaccination failure; Shingles on right arm; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and relugolix (Orgovyx) for prostate cancer. Concurrent medical conditions included prostate cancer. In MAR-2024, the patient received the 2nd dose of Shingrix. In DEC-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Orgovyx. On 24-AUG-2025, less than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Orgovyx, the patient experienced vaccination failure (Verbatim: Lack of drug effect, diagnosed with shingles on right arm, suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on right arm). The patient was treated with valaciclovir hydrochloride (Valtrex) and thuja occidentalis (Terrasil Wart Treatment). The action taken with Orgovyx was unknown. The outcome of the vaccination failure and shingles were not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Orgovyx. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Orgovyx. Additional Information: GSK Receipt Date: 29-AUG-2025 Patient reported that in Dec-2023 he received his first dose and in Mar-2024 he was vaccinated with the second dose of Shingrix in the series. Patient reported he was diagnosed with shingles on 26-AUG-2025 on his right arm. Two days prior to diagnosis he noticed an ache in his shoulder and neck. He also noticed some water blisters on his right arm. Patient stated the pain from his right arm went up into his skull and was prescribed Valtrex for 10 days. Patient began taking Valtrex but has yet to see any effect the medication has had on the shingles at the time of the call. Patient purchased Terrasil ointment and that was helping the itching. Consumer states 2 years ago he was diagnosed with prostate cancer (exact date of diagnosis not disclosed.) States he received radiation (dates not disclosed) and up until one month ago was prescribed Orgovyx for treatment of prostate cancer. Consumer states he was prescribed ORGOVYX therapy for 18 months. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, less than 2 years after receiving Shingrix and Shingrix, in a 77-year-old male 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.
Prostate cancer
ORGOVYX