Received Mar 26, 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; breakout of shingles to forehead, face and around the eyes; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female 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 (about 15 years ago). In AUG-2024, the patient received the 2nd dose of Shingrix. In JUN-2024, the patient received the 1st dose of Shingrix. On 19-FEB-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: breakout of shingles to forehead, face and around the eyes). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure and facial herpes zoster to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the 1st vaccine of Shingrix in June 2024 and 2nd vaccine in August 2024, was unsure of exact date. Patient stated that she had a breakout of shingles that had improved and breakout was to forehead, face and around the eyes. Had to see eye doctor too. This case was considered as suspected vaccination failure as details of 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix.
Medical History/Concurrent Conditions: Shingles (about 15 years ago)