Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Cardiac stress test normal, Echocardiogram abnormal, Eye inflammation, Feeling abnormal
Clinical narrative: Still don't feel right; Heart palpitations aggravated (has been out of control); Heart palpitations aggravated (has been out of control); "Itis" (inflamation) in both eyes; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles outbreak in the eye about 2 years ago.) and gluten free diet (gluten-free diet for 20 years). Previously administered products included Shingrix (She received Shingrix shot #1 on March 1, 2022 and refer this case - US2022AMR133004 for 1st dose.). Concurrent medical conditions included cataract (had for over 2 years and still there which was preventing me from having my cataracts repaired.), mitral valve prolapse (had done an echocardiogram: which showed that I have a valve issue which I knew, I was diagnosed with Mitral Valve Prolapse quite a few years ago. (diagnosed in 1995)), autoimmune disorder (due to celiac sprue been on a gluten-free diet for 20 years) and heart valve disorders.   On 21st June 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling bad, palpitation, condition aggravated and eye inflammation. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling bad, condition aggravated and eye inflammation were not recovered/not resolved and the outcome of the palpitation was recovering/resolving.   It was unknown if the reporter considered the feeling bad to be related to Shingrix. The reporter considered the palpitation, condition aggravated and eye inflammation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR133004   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comments: The reporter was the patient. She had received Shingrix shot #1 on 1st March, 2022 and Shingrix shot #2 on 21st June, 2022. She did not have the lot number for either of the two shots but had provide her pharmacy's name and phone number, from where that information should be on file. She stated, "She knew that from the very 1st shot, she had told her husband, she does not felt right since then and she still did not feel right." She stated, "Ever since she had the 1st dose, shortly after that she got that, she started with really severe heart palpitations. She had been to her doctor about that and she had instructed me to have had the bloodwork done, which was okay, an echocardiogram, which had shown us that she had a valve issue which she knew, since she it was diagnosed as Mitral Valve Prolapse quite a few years ago and she also had a stress test done in which she had passed with no problems. However, the heart palpitations seemed to have been getting a little better before the 2nd dose of Shingrix and since then it had been out of control." She stated, "And now she also had developed, she cannot give us the proper name because she had failed to get that from her eye doctor this morning. But she was now also dealing with some sort of -itis in both of her eyes which was preventing her from having her cataracts repaired. She was supposed to had that done 2 years ago, but she had got shingles in her eye. It appears that -itis that she had in her eyes was an inflammation." The reporter had consented to follow-up. Additional supportive information: As per the reported verbatim  " has been out of control " Condition aggravated was coded conservatively. This case was linked with US2022AMR133004 for same reporter and 1st dose.; Sender's Comments:  US-GSK-US2022AMR133004:Same reporter