Received Jul 3, 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; shingles into the eye; shingles on the right side of his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included leukemia (patient was immune compromised because of leukemia four years ago). 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: shingles into the eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: shingles on the right side of his face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure 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: 27-JUN-2025 Patient was immune compromised because of leukemia four years ago. They wiped out his immune system to get the stem cell transplant and now he had all his childhood vaccinations, and the shingle shot was a last one. Patient had first shot 6 months ago and second one 6 weeks ago and now has shingles on the right side of his face and into the eye. 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 2) Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Medical History/Concurrent Conditions: Leukemia (patient was immune compromised because of leukemia four years ago)