Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; which went into my eye; got the shingles anyway, which went into my eye; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: which went into my eye) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles anyway, which went into my eye). The patient was treated with gabapentin and paracetamol (Tylenol). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and shingles were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingrix and Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and the Shingrix vaccine and got the shingles anyway, which went into eye, and still suffering with after effects of itching and stabbing pains in the area. The patient on 300 microgram gabapentin three times a day, which helps a little, use ice packs and anti-itch cream and Tylenol. 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 vaccine Shingrix and Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix and Shingles vaccine.