Received Aug 12, 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; got shingles about two weeks ago for the first time; eyelid inflamed; eyelid drooping; 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. Previously administered products included Shingles vaccine (The patient received the dose about 10 years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUL-2025, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got shingles about two weeks ago for the first time). On an unknown date, the patient experienced inflammation of eyelids (Verbatim: eyelid inflamed) and eyelid ptosis (Verbatim: eyelid drooping). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster, inflammation of eyelids and eyelid ptosis were resolved (duration 10 days). It was unknown if the reporter considered the vaccination failure, facial herpes zoster, inflammation of eyelids and eyelid ptosis to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster, inflammation of eyelids and eyelid ptosis to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient got a Shingles shot that first came out that he/she think was good for about 10 years. Then they came out with the lifetime Shingles shots where get one and then the second a few months later. It's been a few years till the time of reporting, and he/she got shingles about two weeks ago for the first time from reporting date. It affected face and a strip of it on face's left side. There was a hot burning sensation and right eyelid was inflamed and drooping, badly. Immediate care gave medication and cleared it up within a week. There was also itching. The patient never had it before. The patient had all the shots a few years ago. He/she caught it at its early onset, before 72 hours, and got help. Actually, it took almost 10 days to get it over. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.