Received Mar 4, 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; 2n dose received late; This serious case was reported by a consumer 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. Concurrent medical conditions included chronic lymphocytic leukemia (stable for 17 years), cholesterol and blood pressure. Concomitant products included atorvastatin calcium (Statin). On 14-AUG-2023, the patient received the 2nd dose of Shingrix. On 14-JUL-2022, the patient received the 1st dose of Shingrix. On 14-AUG-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2n dose received late). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the drug dose administration interval too long was not applicable. 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-FEB-2025 The patient reported 3 years after Shingrix vaccination sequence got shingles. The patient was wondering if there was value in repeating the dosage sequence more frequently given, decrease in immune functioning with the chronic lymphocytic leukemia along with age. The patient received 2nd dose at longer time interval then recommended, which led to lengthening of vaccination schedule. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Blood pressure; Cholesterol; Chronic lymphocytic leukemia (stable for 17 years)
Statin