Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
kidney function was not normal/kidney problem; tooth pulled; Blepharitis; very itchy rash all over his body; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Influenza vaccine (Flu vaccine VII) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in JAN-2024), Tetanus (Patient received shot in DEC-2023) and zostavax. In APR-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Flu vaccine VII. In OCT-2024, between 6 and 7 months after receiving Shingrix, the patient experienced itchy rash (Verbatim: very itchy rash all over his body). On an unknown date, the patient experienced renal disorder (Verbatim: kidney function was not normal/kidney problem), tooth extraction (Verbatim: tooth pulled) and blepharitis (Verbatim: Blepharitis). The patient was treated with prednisone, ketotifen fumarate (Zyrtec Itchy), menthol;zinc oxide (Gold Bond), amoxicillin (Amoxicilina) and neomycin hydrochloride;polymyxin B sulfate (Neomycin Polymixin). The outcome of the itchy rash was not resolved and the outcome of the renal disorder, tooth extraction and blepharitis were unknown. It was unknown if the reporter considered the itchy rash, renal disorder, tooth extraction and blepharitis to be related to Shingrix. It was unknown if the company considered the itchy rash, renal disorder, tooth extraction and blepharitis to be related to Shingrix. Additional Information: GSK Receipt Date: 12-FEB-2025 The patient received the first dose of Shingrix in January, 2024, and the second dose in April, 2024. The reporter received a Flu vaccine (manufacturer not known by the reporter) in September, 2024 and a Tetanus shot (manufacturer not known by the reporter) in December 2023. In October 2024, the patient began to develop a very itchy rash all over his body. The patient was treated with Prednisone, which benefits, but once he tapers down, the rash comes back. He was just completing the second course of a Prednisone taper and the rash was coming back, to treat the rash the patient was also taking Zyrtec 2 tablets in the am and 2 tablets in the pm, Gold Bond (formulation not specified), moisturizing creams, and topical Clobetasol (topical clobetasol was not effective). The patient had his house checked for bed bugs, but bed bugs were not found, the patient had 2 different skin Biopsies done which did not show anything. The patient had blood work done in which he states his kidney function was not normal, his eGFR was 55 (it had never been that low before), and a repeat of the blood work indicated an eGFR of 70. The patient's Lymphocyte count was very high, and the leucocytes were a little high. The patient had a tooth pulled (reason for the tooth pull was not provided) about 6 weeks ago, and he was prescribed Amoxicillin status post tooth pull. The Dermatologist was considering putting the patient on Dupixent for treatment for the rash. The patient also had Blepharitis, which started around the same time as the rash and He treated the Blepharitis with a Neomycin / Polymyxin eye ointment. The patient stated that he had not ever had Shingles and has been vaccinated with Zostavax.
Test Name: skin biopsies; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: eGFR; Result Unstructured Data: (Test Result:55,Unit:unknown,Normal Low:,Normal High:); Test Name: eGFR; Result Unstructured Data: (Test Result:70,Unit:unknown,Normal Low:,Normal High:); Test Name: lymphocyte count; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:); Test Name: leucocyte count; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:)