Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
she has discovered a raised rash "looks like small blisters" over the right shoulder, arm and right side of chest.; last night she felt some itching on her right shoulder and upper arm/Itching papule; This non-serious case was reported by a consumer via call center representative and described the occurrence of itching papule in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included clotting disorder (Anticoagulant therapy) and indigestion. Concomitant products included rivaroxaban (Xarelto) and aluminium hydroxide gel, dried, magnesium carbonate (Pepcid). On 23-JUL-2025 16:00, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 23-JUL-2025 22:00, 6 hrs after receiving Shingrix, the patient experienced itching papule (Verbatim: last night she felt some itching on her right shoulder and upper arm/Itching papule). On 24-JUL-2025, the patient experienced raised rash (Verbatim: she has discovered a raised rash "looks like small blisters" over the right shoulder, arm and right side of chest.). The outcome of the itching papule and raised rash were not resolved. It was unknown if the reporter considered the itching papule and raised rash to be related to Shingrix. It was unknown if the company considered the itching papule and raised rash to be related to Shingrix. Additional Information: GSK Receipt date: 24-JUL-2025 The patient reported that she received her first Shingrix dose yesterday at 4pm in her left deltoid. No other vaccines were administered. Beginning at 10 pm last night she felt some itching on her right shoulder and upper arm. This morning, she had discovered a raised rash looked like small blisters over the right shoulder, arm and right side of chest.
Clotting disorder (Anticoagulant therapy); Indigestion
XARELTO; Pepcid