Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Got the right eye; down his/her throat and roof of his/her mouth; Herpes zoster; inside of his/her nose had a spot where blood was coming out of; Herpes zoster; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. In NOV-2023, an unknown time after receiving Shingles vaccine, the patient experienced herpes zoster (Verbatim: Herpes zoster). In APR-2024, the patient experienced herpes zoster (Verbatim: Herpes zoster). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: Got the right eye) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: down his/her throat and roof of his/her mouth) and epistaxis (Verbatim: inside of his/her nose had a spot where blood was coming out of). In NOV-2024, the outcome of the herpes zoster was resolved. The outcome of the ophthalmic herpes zoster, oral herpes zoster, herpes zoster and epistaxis were resolving. It was unknown if the reporter considered the ophthalmic herpes zoster, oral herpes zoster, herpes zoster, herpes zoster and epistaxis to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the oral herpes zoster, herpes zoster, herpes zoster and epistaxis to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles in his/her head. Patient had one shot before but never got the second, as he/she was afraid it would come back. However, it did return. The first occurrence was in November, and the second time was in April the following year, lasting until November 2024. It affected his/her right eye, the right side of his/her face, the top of his/her head, down his/her throat, the roof of his/her mouth, and even ate a hole in his/her nose. Inside his/her nose, there was a spot where blood was coming out. Eventually, it started to get better, but it took time.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.