Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; still got shingles on his face and tongue; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: still got shingles on his face and tongue). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix. Additional Information: GSK receipt date: 21-MAY-2025 This case was reported by a patient's sibling via interactive digital media. The reporter reported that his/her brother had the Shingrix vaccines and still got shingles on his face and tongue which he was still suffering from for over 2 months at this point. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix