Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Breast pain, Burning sensation, Herpes zoster, Pain, Pain in extremity
Clinical narrative: 2nd dose in september, has shingles since saturday/ HCP reported belief rash was Shingles  / Suspected vaccination failure; HCP reported belief rash was Shingles; rash on breast / also on shoulder / rash was sore to the touch; rash was burning; sharp, shooting pain in breast; soreness in left arm; rash was sore to the touch; rash was itching; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Flu unspecified (Flu vaccine) for prophylaxis.   In September 2022, the patient received the 2nd dose of Shingrix. In April 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Flu vaccine. In November 2022, between 1 and 3 months after receiving Shingrix, between 6 and 8 months after receiving Shingrix and unknown after receiving Flu vaccine, the patient experienced burning sensation, breast pain, pain in arm, pain and itchy rash. On 26th November 2022, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with topical antibiotic (nos) (Antibiotic Cream (Nos)). On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles, breast pain and pain in arm were not recovered/not resolved and the outcome of the burning sensation, itchy rash and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, breast pain, pain in arm, pain, itchy rash and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the burning sensation, breast pain, pain in arm, pain, itchy rash and rash to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 28-NOV-2022. Reporter's comment: The reporter was the patient who had reported that she had received both doses of Shingrix.  She believed that, she had received the first dose in April and the second dose in September of this year. She reported of noticing rash on left breast last Saturday. She had reported that, the rash was itching and burning. She also reported of feeling sharp, shooting pain in left breast. She had reported that, her primary Healthcare Professional (HCP) had belief that the rash was Shingles and provided her with antibiotics and a cream to treat the itching and burning.  She had also reported of developing rash on left shoulder approximately 2 days ago, after receiving an unknown Flu vaccine. She had reported a rash on should consisted of itching, burning and was sore to the touch. She had reported using the same cream on rash on should to relieve her from itch and burning.  She reported of being unaware of whether the rash had spread from breast to shoulder or if the reaction was related to receipt of Flu vaccine, in left arm. She had reported of itching and burning or rashes had resolved. She also reported of continuing to experience shooting pain in left breast and soreness in left arm. The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding  laboratory confirmation regarding shingles were unknown at the time of reporting.