Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspeceted vaccination failure; I got shingles after the Shingrix vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles after the Shingrix vaccines). 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. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that she got shingles after the administration of Shingrix vaccine. 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.
Medical History/Concurrent Conditions: Shingles