Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Vaccination failure
Clinical narrative: suspected vaccination failure; thinks this is shingles; sensitive to the touch; burning pain at the top of her thigh for several hours then it resolved; she noted that she had ad rash with bumps that were red, raised, but dry on the left side of her trunk; Yesterday, she noted that she had ad rash with bumps that were red, raised, but dry on the left side of her trunk, her left buttock, and the left side of her groin area; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received mepolizumab (Nucala) powder for solution for injection for drug use for unknown indication.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient started Nucala (subcutaneous) 100 mg every 4 weeks, the 2nd dose of Shingrix and the 1st dose of Shingrix. On 09-SEP-2024, an unknown time after receiving Nucala, Shingrix and Shingrix, the patient experienced generalized raised red spots trunk (Verbatim: she noted that she had ad rash with bumps that were red, raised, but dry on the left side of her trunk) and red spotty rash (Verbatim: Yesterday, she noted that she had ad rash with bumps that were red, raised, but dry on the left side of her trunk, her left buttock, and the left side of her groin area). In SEP-2024, the patient experienced pain burning (Verbatim: burning pain at the top of her thigh for several hours then it resolved). On an unknown date, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: thinks this is shingles) and touch sensitivity increased (Verbatim: sensitive to the touch). The action taken with Nucala was unknown. In SEP-2024, the outcome of the pain burning was resolved. The outcome of the vaccination failure was unknown and the outcome of the shingles, touch sensitivity increased, generalized raised red spots trunk and red spotty rash were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, touch sensitivity increased, pain burning, generalized raised red spots trunk and red spotty rash to be related to Nucala, Shingrix and Shingrix.     The company considered the vaccination failure to be related to Nucala, Shingrix and Shingrix. It was unknown if the company considered the shingles, touch sensitivity increased, pain burning, generalized raised red spots trunk and red spotty rash to be related to Nucala, Shingrix and Shingrix.    GSK Receipt Date: 10-SEP-2024 Consumer reported that she received the Nucala injection at an infusion center once monthly and had five doses. She had her most recent dose on Friday, September 6, 2024. She reported that over the weekend she experienced burning pain at the top of her thigh for several hours, and then it resolved. Yesterday, she noted that she had rash with bumps that were red, raised, but dry on the left side of her trunk, her left buttock, and the left side of her groin area. It was sensitive to the touch. Also, she thought there was a little more of the rash today compared with yesterday. She thought this was shingles and would be going to her physician tomorrow. She reported that she had a Shingrix vaccine, consisting of two doses, approximately two years ago. Consented to follow up. Call Notes: Reporter gave permission for her physician to be contacted but did not have their information available at the time of the call. Unable to obtain additional information.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK drug Nucala   Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.