Received Mar 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 after I got the second vac, in the face and in my right eye; nerve damage in my eye; got shingles after I got the second vac, in the face and in my right eye; nerve damage in parts of my forehead; 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), ophthalmic herpes zoster (Verbatim: got shingles after I got the second vac, in the face and in my right eye) (serious criteria GSK medically significant), optic nerve damage (Verbatim: nerve damage in my eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: got shingles after I got the second vac, in the face and in my right eye) and post herpetic neuralgia (Verbatim: nerve damage in parts of my forehead). The outcome of the vaccination failure, ophthalmic herpes zoster and facial herpes zoster were not reported and the outcome of the optic nerve damage and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, optic nerve damage, facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, ophthalmic herpes zoster and optic nerve damage to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles after got the second dose of Shingles vaccine, in the face and in The right eye. That was three years ago and still have nerve damage in eye and parts of forehead. The patient would not want to do that again. This case was considered as suspected vaccination failure since the details regarding 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. Optic nerve injury is an unlisted event which is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2.