Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic dissection, Fatigue, Pain in extremity, Psoriasis, Sunburn
Clinical narrative: Aortic dissected; Sunburn; Psoriasis; sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC DISSECTION (Aortic dissected) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included Open heart surgery in July 2021. Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced AORTIC DISSECTION (Aortic dissected) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SUNBURN (Sunburn), PSORIASIS (Psoriasis), PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigue). At the time of the report, AORTIC DISSECTION (Aortic dissected), SUNBURN (Sunburn), PSORIASIS (Psoriasis), PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In July 2021, the patient had an emergency open heart surgery for dissected aorta. he had sunburn over the weekend. he had psoriasis, occasional itching, and plaques. he had fatigue and sore arm due to covid-19 vaccine. the reporter's causality for the event(s) of aorta dissected, sunburn, sore arm, fatigue due to Covid vaccine, occasional itching, and plaques with Skyrizi (risankizumab)was not provided.  This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation # QE - 020343  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 68-year-old male patient with relevant medical condition of Psoriasis, who was hospitalized due to the unexpected serious (medically significant) event of Aortic dissection, which occurred approximately 2 months after receiving the first dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of approximately 3 months, which did not fall within the recommended vaccine dosing schedule, approximately 9 months prior to third mRNA-1273 vaccination (Inappropriate schedule of vaccine administered). Patient also had psoriasis with occasional itching and plaques, fatigue and sore arm due to COVID-19 vaccine. The patient underwent an emergency open heart surgery for dissected aorta. Outcome of the events were unknown. The medical condition of Psoriasis increases the risk of aortic aneurysm which may lead to a tear in the aortic lining or aortic dissection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-627425 (Patient Link).; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 68-year-old male patient with relevant medical condition of Psoriasis, who was hospitalized due to the unexpected serious (medically significant) event of Aortic dissection, which occurred approximately 2 months after receiving the first dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of approximately 3 months, which did not fall within the recommended vaccine dosing schedule, approximately 9 months prior to third mRNA-1273 vaccination (Inappropriate schedule of vaccine administered). Patient also had psoriasis with occasional itching and plaques, fatigue and sore arm due to COVID-19 vaccine. The patient underwent an emergency open heart surgery for dissected aorta. Outcome of the events were unknown. The medical condition of Psoriasis increases the risk of aortic aneurysm which may lead to a tear in the aortic lining or aortic dissection. The benefit-risk relationship of mRNA-1273 is not affected by this report.