Age: 54.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Back pain, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: she has hypothyroidism (Hashimoto's disease).; The pain lasted for a few minutes then became manageable/ pain (left bicep and triceps); rash that was itchy; Rash was red (redness)/ (it has decreased in size, warmness and redness); Hot rash; raised  rash; her back was itchy; she had slight wheezing; She also also experienced a fever the following day which has resolved; her left bicep and triceps felt like they were on fire; This case was reported by a consumer via call center representative and described the occurrence of hypothyroidism in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included pain. Previously administered products included Shingrix (1st dose received on 3rd June 2022 and also experienced chills, fever, and pain at the injection site, refer case US2022AMR141776). Concurrent medical conditions included hashimoto's disease.   On 30th September 2022, the patient received the 2nd dose of Shingrix. On 30th September 2022, immediately after receiving Shingrix, the patient experienced localized feeling of warmth. On 1st October 2022, the patient experienced fever. On an unknown date, the patient experienced hypothyroidism (serious criteria GSK medically significant), pain in arm, itchy rash, red rash, heat rash, raised rash, pruritus and wheezing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hypothyroidism was unknown and the outcome of the localized feeling of warmth, red rash, heat rash and raised rash were recovering/resolving and the outcome of the pain in arm, fever and wheezing were recovered/resolved and the outcome of the itchy rash and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the hypothyroidism, localized feeling of warmth, pain in arm, fever, itchy rash, red rash, heat rash, raised rash, pruritus and wheezing to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR141776   Additional Information: GSK receipt date: 03-OCT-2022 Reporters comment: The patient self-reported this case. Immediately after the second dose, the patient's left bicep and triceps felt like they were on fire. The pain lasted for a few minutes then became manageable. She also experienced a fever the following day which had resolved. Right below the injection site, she developed a rash that was itchy, red, hot and raised that was bigger than the size of a softball. She also stated that her back was itchy, and she had slight wheezing. She stated that the rash on her left arm was getting better (it had decreased in size, warmness and redness). Her arm and back were still itchy, but her wheezing had resolved. She also stated that she has hypothyroidism (Hashimoto's disease). The reporter did not consent to follow up. Additional Supportive Information: Hypothyroidism was conservatively captured as event as it was unclear occurred before or after vaccination and events itchy, red, hot and raised were clubbed with rash as per reported description; Sender's Comments:  US-GSK-US2022AMR141776:Same reporter