Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Hives; Itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cardiac pacemaker insertion (pacemaker insertion (cardiac)) and covid-19 (had COVID infection four times). Concurrent medical conditions included hypertension, fruit allergy (allergy (hives) with stewed tomatoes) and allergy (has reactions (allergy/sensitivity) to unspecified allergens). Concomitant products included losartan, amlodipine, citalopram and acetylsalicylic acid (Aspirin). In APR-2025, the patient received the 1st dose of Shingrix (intramuscular use, unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hives) and pruritus (Verbatim: Itching). The patient was treated with calamine, menthol, zinc oxide (Calamine) and triamcinolone acetonide (Triamcinolone). The outcome of the hives and pruritus were not resolved. It was unknown if the reporter considered the hives and pruritus to be related to Shingrix. It was unknown if the company considered the hives and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter was the patient. She had her first Shingrix dose and she did not know the exact date. The pharmacy where she received the vaccination did not provide the lot number and expiry date to her. About two weeks after vaccination, she developed hives and itching from head to toe in 2025. She treated the hives and itching with calamine lotion. Her healthcare provider treated the hives and itching with a Z-pack (azithromycin), triamcinolone cream, and an unknown medication that came in a taper pack. The hives have not resolved. The itching has worsened. She planned to see a dermatologist. Nothing else was reported.
Allergy (has reactions (allergy/sensitivity) to unspecified allergens); Fruit allergy (allergy (hives) with stewed tomatoes); Hypertension
Medical History/Concurrent Conditions: Cardiac pacemaker insertion (pacemaker insertion (cardiac)); COVID-19 (had COVID infection four times)
LOSARTAN; AMLODIPINE; CITALOPRAM; ASPIRIN