Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3G5T3 | IM / RA |
itchy red spots; pain at injection site; Bruised arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis. The patient's past medical history included kidney transplant (The patient reports she did receive a kidney transplant 6 years ago and is on anti-rejection medication). On 19-NOV-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On 19-NOV-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site) and bruising of arm (Verbatim: Bruised arm). On 24-NOV-2024, the patient experienced itchy rash (Verbatim: itchy red spots). The outcome of the injection site pain was resolved and the outcome of the bruising of arm and itchy rash were not resolved. It was unknown if the reporter considered the injection site pain, bruising of arm and itchy rash to be related to Shingrix. It was unknown if the company considered the injection site pain, bruising of arm and itchy rash to be related to Shingrix. Additional Information: GSK Receipt Date: 06-FEB-2025 Caller was the patient and reported she received her second Shingrix vaccine in her right arm on November 19. 2024. The pharmacist injected it very low on her upper arm, about 4 "above her elbow, the bruise is still there. Patient reported there was pain at the injection site that has been resolved. Caller reported less than a week after the Shingrix injection she began experiencing an itchy spot mainly from her shoulders up to her head. The red itchy spots are the size of a dime, some a pencil eraser size and one was the size of a 50-cent piece. The Patient reported she went to the health care professional on 12-Apr-2024 and the HCP gave her a steroid cream for the itching. The caller went back to the HCP and the HCP took a biopsy of 50 percent piece size spot on 05-Feb-2025 and the results will take a week. Caller describes the red itchy spots as coming and going but they never resolve. She also had a spot near her panty line. Caller does had pictures to share if needed. The patient reported she did receive a kidney transplant 6 years ago and is on anti-rejection medication. The reporter consented to follow up.
Medical History/Concurrent Conditions: Kidney transplant (The patient reports she did receive a kidney transplant 6 years ago and is on anti-rejection medication)
Test Date: 20250205; Test Name: biopsy; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:)