Received Mar 5, 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; I've had shingles 5 times received both Shingrix vaccines get milder each time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles 5 times). Concurrent medical conditions included leukemia. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've had shingles 5 times received both Shingrix vaccines get milder each time). The outcome of the vaccination failure and shingles were 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: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles 5 times and yes then patient received both Shingrix vaccines and they get milder each time. The patient's hematology oncologist attributed this to his/her leukemia. This case was considered as suspected vaccination failure since the details regarding the 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Leukemia
Medical History/Concurrent Conditions: Shingles (had shingles 5 times)