Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | LA |
She experienced itchiness; redness; burning on the left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose of shingrix on an unknown date). In JAN-2025, the patient received the 2nd dose of Shingrix (left arm). In JAN-2025, 24 hrs after receiving Shingrix, the patient experienced pruritus (Verbatim: She experienced itchiness), erythema (Verbatim: redness) and burning sensation (Verbatim: burning on the left arm). The patient was treated with acrivastine (Benadryl). (Dechallenge was positive). Rechallenge with Shingrix was positive. The outcome of the pruritus was resolved and the outcome of the erythema and burning sensation were not resolved. It was unknown if the reporter considered the pruritus, erythema and burning sensation to be related to Shingrix. It was unknown if the company considered the pruritus, erythema and burning sensation to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2025 Reporter was the patient who received her second dose of SHINGRIX about 2 and a half days ago. She experienced itchiness, redness, and burning on the left arm. Patient received the dose on her left arm as well. The itching started about 24 hours after the dose and had resolved. The redness started within 48 hours and was still present. It was about 5 inches by 1 inches long. She took one dose of Benadryl last night.