Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
mild shingles outbreak two months ago; suspected vaccination failure/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 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included polymyalgia rheumatica (experienced 20 years ago, treated with one round of Prednisone and it resolved.). Previously administered products included Prednisone (polymyalgia rheumatica treated with one round of Prednisone). Concurrent medical conditions included hypercholesterolemia and atrial fibrillation. Concomitant products included lovastatin and apixaban (Eliquis). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) and the 1st dose of Shingrix (intramuscular, unknown deltoid). In MAY-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: mild shingles outbreak two months ago). In MAY-2025, the outcome of the shingles was resolved. The outcome of the vaccination failure was not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. 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 and Shingrix. Additional Information: GSK receipt date: 23-JUL-2025 The patient reported that he had received both doses of Shingrix about 10 years ago, stating it had been confirmed to be "the new vaccine." He experienced a mild shingles outbreak two months prior. He had only a few lesions on his right back and side, accompanied by tingling on the right side and right front of his trunk. This was treated and resolved quickly. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Atrial fibrillation; Hypercholesterolemia; Polymyalgia rheumatica (experienced 20 years ago, treated with one round of Prednisone and it resolved.)
LOVASTATIN; ELIQUIS