Received Apr 18, 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; got shingles in my eye; got shingles in my scalp, face last fall; Hearing has been affected; 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. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: got shingles in my eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: got shingles in my scalp, face last fall) and hearing impaired (Verbatim: Hearing has been affected). The outcome of the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and hearing impaired were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and hearing impaired to be related to Shingrix and Shingrix. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster and hearing impaired to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The patient got both Shingrix vaccinations and just got shingles in his/her eye, scalp, face last fall and the hearing had been affected and it had been awful. This case was considered as suspected vaccination failure since the details regarding the 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1& 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1& 2).