Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Lichen Sclerosus Flare; Lichen Sclerosus Flare; Yeast infection; Uncomfortable; This non-serious case was reported by a consumer via call center representative and described the occurrence of lichen sclerosus in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included lichen sclerosus (patient was diagnosed with Lichen Sclerosus in her genital area a year ago). On 11-NOV-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced lichen sclerosus (Verbatim: Lichen Sclerosus Flare), condition aggravated (Verbatim: Lichen Sclerosus Flare), yeast infection (Verbatim: Yeast infection) and discomfort (Verbatim: Uncomfortable). The outcome of the lichen sclerosus, condition aggravated and discomfort were not resolved and the outcome of the yeast infection was resolved. The reporter considered the lichen sclerosus and condition aggravated to be possibly related to Shingrix. It was unknown if the reporter considered the yeast infection and discomfort to be related to Shingrix. The company considered the lichen sclerosus and condition aggravated to be possibly related to Shingrix. It was unknown if the company considered the yeast infection and discomfort to be related to Shingrix. Additional Information: GSK receipt date: 06-MAY-2025 The reporter was female patient that was diagnosed with Lichen Sclerosus in her genital area a year ago, pre-existing receiving the first dose of Shingrix. The patient reported that after she received the first dose of Shingrix (no specific date provided), she had a flare of her Lichen Sclerosus, and this flare had been going on for a couple of months now (no specific dates provided). The patient reported that the flare was very uncomfortable. The patient reported that after the flare of her Lichen Sclerosus occurred, she also experienced a yeast infection (no specific date provided, which had cleared up at the time of reporting. The patient reported that she used Clobetasol Ointment 0.01% topically twice a day on the rash in the area of the flare on her genitals. The patient reported that her physician told her that the Lichen Sclerosus flare could be related to receiving the first dose of Shingrix. The patient did not had a Lot/Expiry/NDC/or route of administration for the Shingrix first dose.
Lichen sclerosus (patient was diagnosed with Lichen Sclerosus in her genital area a year ago)