Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; shingle in one eye; one my face; a droopy eye lid; 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 (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingle in one eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: one my face) and eyelid ptosis (Verbatim: a droopy eye lid). The outcome of the vaccination failure and eyelid ptosis were not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and eyelid ptosis to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster and eyelid ptosis to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-SEP-2025 This case was reported by a patient via interactive digital media. The patient mentioned that he/she had a mild case of shingles on the face and one eye, along with a droopy eyelid. However, with medications, it did not last long. The patient had received both shots at least two or three years before this occurred. The patient enquired if anyone else had received the shots but still got shingles afterward. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster , 2 years after receiving Shingles vaccine (Dose 1 and Dose 2) in a patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.