Received Apr 15, 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 | — |
Shingles on forehead close to eyes/ suspected vaccination failure; Shingles on forehead close to eyes; spent a day in bed; Migraines were worse; 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: Shingles on forehead close to eyes/ suspected vaccination failure) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: Shingles on forehead close to eyes), bedridden (Verbatim: spent a day in bed) and migraine (Verbatim: Migraines were worse). The outcome of the vaccination failure, facial herpes zoster and migraine were not reported and the outcome of the bedridden was resolved. It was unknown if the reporter considered the vaccination failure, facial herpes zoster and migraine to be related to Shingles vaccine and Shingles vaccine. The reporter considered the bedridden to be related to 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 and migraine to be related to Shingles vaccine and Shingles vaccine. The company considered the bedridden to be related to Shingles vaccine. Additional Information: GSK receipt date: 07-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles on forehead close to the eyes. The patient suffered from severe migraines and it felt a lot like that. However, when the blisters showed up the patient realized what it was. The patient was so used to migraines and vomiting, that the patient mistook the pain. By the time the patient made it to the doctor it was too late to treat it but the doctor sent the patient to an ophthalmologist. Fortunately, the patient's eye was ok. The patient had both shingles vaccinations 3 years ago. The second shot made the patient sick and had spent a day in bed. The shingles pain was sharp and intense but the migraines were even worse because they were so frequent. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).