Received Mar 21, 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; still got shingles in my ear; still got shingles in my eye; the side of my face; 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: still got shingles in my ear) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: still got shingles in my eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: the side of my face). The outcome of the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, herpes zoster otitis externa and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date : 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had two shingles shots and still got shingles in his/her ear, eye, the side of his/her face. Excruciated pain in his/her eye, ear and side of his/her head and face. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). Herpes zoster oticus and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).