Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; lost my hearing; shingles; 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. 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), hearing loss (Verbatim: lost my hearing) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure, hearing loss and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The reporter considered the hearing loss to be related to Shingrix. The company considered the vaccination failure and hearing loss to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that she got Shingrix vaccine and she experienced shingles and loss of hearing. They made go to all the test and it cost patient to find out by her old fashion physician. Consumer stated that if you don't need shingle shot you already have shingles and getting the shot was useless. 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. The follow-up could not be possible as no contact details were available.; 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. Deafness is an unlisted event which is considered unrelated to GSK vaccine Shingrix.