Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
suspected vaccination Failure; developed Shingles in the last few days on head and face; 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. On an unknown date, the patient received Shingrix. In JUL-2025, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles in the last few days on head and face). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine last year (2024) and just developed shingles in the last few days from reporting. The shingles was not severe but on head and face. The sores were around mouth making it hard to eat and drink, shooting pains in jaw to ear and beyond. Started medication one day prior to the reporting date (07-July-2025). The patient stated hoping it clears up quickly and did not get in ear or eye. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and 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, and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix.