Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
sore arm; Feeling cold; Fatigue; hives on both arms; Itching; breathing heavy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included diclofenac sodium (Diclofenac), thyroid, cholesterol and cortisone acetate (Cortisone). In MAR-2025, the patient received the 1st dose of Shingrix. On 09-APR-2025, less than a month after receiving Shingrix, the patient experienced hives (Verbatim: hives on both arms), pruritus (Verbatim: Itching), labored respiration (Verbatim: breathing heavy) and fatigue (Verbatim: Fatigue). On an unknown date, the patient experienced pain in arm (Verbatim: sore arm) and feeling cold (Verbatim: Feeling cold). The outcome of the hives, pruritus, labored respiration and fatigue were not resolved and the outcome of the pain in arm was resolved and the outcome of the feeling cold was unknown. It was unknown if the reporter considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix. It was unknown if the company considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix. Additional Information: GSK Receipt Date: 10-APR-2025 The reporter is the patient's husband. He stated that the patient received her first dose of Shingrix about 2 or 3 weeks ago. She experienced a sore arm which went away. Yesterday, she developed hives on both her arms. She was also experiencing itching on her back. The reporter applied some cortisone cream to her back last night. The patient was also breathing heavy, has fatigue, and is feeling cold. This case was linked with case US2025044416 from the same reporter.; Sender's Comments: US-GSK-US2025044416:same reporter
DICLOFENAC; THYROID; CHOLESTEROL; CORTISONE