Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
reddish-gray areas of skin discoloration remain; rash started on her torso; she developed a dry, itchy rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Shingles), stroke (Has had two strokes. The first one was about two years ago and the second in Mar 2025.), heart attack (Heart attack about two years ago) and rash (frequent rashes). Concurrent medical conditions included drug allergy (Allergic to neomycin and other unspecified antibiotics). On 15-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 22-APR-2025, 7 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: she developed a dry, itchy rash). On an unknown date, the patient experienced skin discolouration (Verbatim: reddish-gray areas of skin discoloration remain) and rash (Verbatim: rash started on her torso). The patient was treated with prednisone acetate (Prednisone) and clobetasol propionate (Clobetasol). The outcome of the itchy rash and rash were resolving and the outcome of the skin discolouration was not resolved. It was unknown if the reporter considered the itchy rash, skin discolouration and rash to be related to Shingrix. It was unknown if the company considered the itchy rash, skin discolouration and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 04-JUN-2025 The case was self reported by patient, she was also a retired health care professional(nurse). On 15 Apr 2025 she received her first Shingrix dose and on 22 Apr 2025 she developed a dry, itchy rash. The rash started on her torso. Over the next two weeks, the rash spread to both arms (not near the injection site), and her back. She saw an health care professional for the rash and was given oral prednisone for ten days. About two weeks after seeing an health care professional, she saw her dermatologist and was treated with clobetasol cream 0.025 percent twice daily. A biopsy of the rash showed hypersensitivity to an arthropod or a medication. The rash was resolving, but reddish gray areas of skin discoloration remain where the rash has healed. She was on numerous medications but declined to provide the list during this call. Nothing else was reported.
Drug allergy (Allergic to neomycin and other unspecified antibiotics)
Medical History/Concurrent Conditions: Heart attack (Heart attack about two years ago); Rash (frequent rashes); Shingles; Stroke (Has had two strokes. The first one was about two years ago and the second in Mar 2025.)