Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass, Headache, Postoperative wound infection, Spinal operation
Clinical narrative: Bypass heart surgery via right leg; There was some infection; Lower spine surgery; Bad headache with second covid 19 vaccine with Skyrizi (risankizumab); This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (Lower spine surgery), CORONARY ARTERY BYPASS (Bypass heart surgery via right leg) and POSTOPERATIVE WOUND INFECTION (There was some infection) in a 63-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]) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, 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 March 2021, the patient experienced HEADACHE (Bad headache with second covid 19 vaccine with Skyrizi (risankizumab)). On 08-Jun-2021, the patient experienced SPINAL OPERATION (Lower spine surgery). On 22-Sep-2021, the patient experienced CORONARY ARTERY BYPASS (Bypass heart surgery via right leg) and POSTOPERATIVE WOUND INFECTION (There was some infection) (seriousness criterion medically significant). In 2021, HEADACHE (Bad headache with second covid 19 vaccine with Skyrizi (risankizumab)) had resolved. At the time of the report, SPINAL OPERATION (Lower spine surgery) and CORONARY ARTERY BYPASS (Bypass heart surgery via right leg) was resolving and POSTOPERATIVE WOUND INFECTION (There was some infection) outcome was unknown.            Company comment: This is a spontaneous case concerning a 63-year-old male patient with Plaque psoriasis on treatment with Risankisumab, who experienced the serious (medically significant) unexpected events coronary artery bypass and postoperative wound infection . The events occurred on unknown dates after vaccination with mRNA-1273. two months and 10 days after 2nd dose, patient had a lower spine surgery. Tree and a half months later, patient had a bypass heart surgery and experienced a postoperative wound infection. Toilette was performed and ATB was prescribed. Clinical course, diagnostic tests and additional treatment details were not provided. On an unknown date during same year, received third dose of mRNA-1273. Risankizumab was reported as a co-suspect product. Events seriousness captured as per assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were reported.   It was reported that, in Mar-2021, the patient had real bad headache with second Covid-19 vaccine. He was advised from health care professional to stop taking Skyrizi prior to lower spine surgery. So, his last Skyrizi dose was on 19-Feb-2021. On 08-Jun-2021, he had lower spine surgery. On 22-Sep-2021, he had bypass heart surgery via right leg. There was some infection so, they opened it back up, and cleaned it up and put him on antibiotics. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality for the event(s) of lower spine surgery, bypass heart surgery via right leg/there was some infection onset 22-Sep-2021 and bad headache with second covid 19 vaccine with skyrizi (risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of bypass heart surgery via right leg/there was some infection onset in 2021 was not provided.   No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain e   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 63-year-old male patient with Plaque psoriasis on treatment with Risankisumab, who experienced the serious (medically significant) unexpected events coronary artery bypass and postoperative wound infection . The events occurred on unknown dates after vaccination with mRNA-1273. two months and 10 days after 2nd dose, patient had a lower spine surgery. Tree and a half months later, patient had a bypass heart surgery and experienced a postoperative wound infection. Toilette was performed and ATB was prescribed. Clinical course, diagnostic tests and additional treatment details were not provided. On an unknown date during same year, received third dose of mRNA-1273. Risankizumab was reported as a co-suspect product. Events seriousness captured as per assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report.