Received Jun 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure / Lack of drug effect; shingles on the side of his stomach-a few small red spots / Lack of drug effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 vaccine for prophylaxis. The patient's past medical history included epstein-barr viremia (Epstein Barre and elevated levels of virus in system, diagnosed when he was child). On 18-JAN-2022, the patient received the 2nd dose of Shingrix. On 11-OCT-2021, the patient received the 1st dose of Shingrix. On 18-OCT-2021, the patient received COVID-19 vaccine. On an unknown date, more than 2 years after receiving Shingrix and Shingrix and not applicable after receiving COVID-19 vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on the side of his stomach-a few small red spots / Lack of drug effect). The patient was treated with valaciclovir hydrochloride (Valtrex). 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 and Shingrix. It was unknown if the reporter considered the shingles to be related to COVID-19 vaccine. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and COVID-19 vaccine. Additional Information: GSK Receipt Date: 10-JUN-2025 The patient self-reported this case for himself. The patient had completed the series for Shingrix with 2 doses. About 7 to 10 days ago in 2025, he was diagnosed with shingles on the side of his stomach (a few small red spots or lack of effect). This diagnosis was made by a dermatologist. The patient was prescribed Valtrex (unknown if generic or brand dispensed, strength not disclosed) to be taken twice daily for 5 days. The patient stated that he was vaccinated with a COVID booster (unknown manufacturer). In 2025, more than 2 years after received COVID-19 vaccine, the patient experienced shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. No further information was obtained or provided.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (concomitant COVID-19 vaccine, h/o epstein-barr viremia and insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Medical History/Concurrent Conditions: Epstein-Barr viremia (Epstein Barre and elevated levels of virus in system, diagnosed when he was child)
Comments: The patient went to an endocrinologist recently and lab work was done that showed Epstein-Barr EBV capsid value greater than 600 and another value was 137. This was for the EBV nuclear antibody test results.