Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | UNK | — |
vaccination failure; internal shingles/burning of skin/pain; itchy rash; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. The patient's past medical history included burning sensation. Concurrent medical conditions included blood cholesterol increased, ulcerative colitis and immunocompromised (her immune system was low due to medication HUMIRA). Concomitant products included risankizumab (Skyrizi), adalimumab (Humira) and rosuvastatin calcium (Crestor). Family history included shingles. On 14-SEP-2022, the patient received the 2nd dose of Shingrix. On 14-JUL-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Zostavax. In NOV-2024, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Zostavax, the patient experienced itchy rash (Verbatim: itchy rash). On 20-MAY-2025, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: internal shingles/burning of skin/pain). The patient was treated with prednisone. The outcome of the vaccination failure was unknown and the outcome of the zoster sine herpete was resolved and the outcome of the itchy rash was not resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and itchy rash to be related to Shingrix, Shingrix and Zostavax. It was unknown if the company considered the vaccination failure, zoster sine herpete and itchy rash to be related to Shingrix, Shingrix and Zostavax. Additional Information: GSK Receipt Date: 28-JUL-2025, 29-JUL-2025 Consumer stated that throughout her life she would have a burning feeling on her skin that did not develop into anything, and she does have a family history of Shingles. Also stated that her immune system was low due to medication Humira, and her PCP did lab work that confirmed the consumer had a case of shingles. Consumer did not have any blisters, only pain and burning on her side, therefore, she was diagnosed with internal shingles. Consumer states she had burning of skin around the left side of her trunk from her belly button to her back on the left side. Consumer stated this lasted a few weeks. She stated she was vaccinated in 2016 and the consumer stated she is not sure that she was vaccinated with Shingrix. Consumer wondered if she was vaccinated with Zostavax. Consumer stated in November she fell out of remission when on Humira and the PCP changed her medication to Skyrizi. She was put on prednisone for 6 weeks in November 2024. The consumer also stated since November 2024 she has had a itchy rash on the left side of her trunk and does not know what the rash is. Consumer stated she is unsure if she mentioned this rash to her PCP at the time she was diagnosed with internal shingles and the rash has not resolved and it unsure why the rash did not go away when she was given prednisone.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK Shingrix.
Blood cholesterol increased; Immunocompromised (her immune system was low due to medication HUMIRA); Ulcerative colitis
Medical History/Concurrent Conditions: Burning sensation; Shingles
SKYRIZI; HUMIRA; CRESTOR