Sex: F
Vaccine: COVID19, UNK
Symptoms: Laboratory test, Limb discomfort, Wound infection
Clinical narrative: ANTIPHOSPHOLIPID SYNDROME; REDUCED VASCULARIZATION IN LEFT HAND; HEART ISSUES GOING AT 35 NOT 55-60 IN HER LEFT VENTRICLE; CUT ON HAND WITH POSSIBLE INFECTION; ISSUE WITH  BACK OF CALVES; HEADACHE; This solicited report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had issues with her abdominal cavity and high blood pressure when she was first diagnosed with Crohn's disease and had been on one medicine ever since but her cardiologist added a new medication recently. The patient stated she was fine as far as Crohn's disease and was off steroids. The patient was treated with ustekinumab (injection, route of admin, batch and expiry was not reported) dose, frequency were not reported from 30-APR-2021 and received the most recent injection on 20-AUG-2021 for Crohn's disease.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch and expiry was not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient stated that she started Stelara and received the Covid vaccine around the same time. On unspecified date, the patient experienced a headache in the afternoon for 3-4 days after injection. The patient noticed her hand was tingly and at first they thought it was Raynaud's but after testing they found that she had reduced vascularization in left hand and might need surgery in the future. The patient had a cut on her hand, she thought was infected and her primary care prescribed her antibiotics. On an unspecified date after vaccination, the patient developed circulatory issues and was diagnosed with APS (antiphospholipid syndrome) an autoimmune clotting disorder. In OCT-2021, the patient had bypass on brachial artery. On an unspecified date, the patient experienced an issue with the back of her calves (calf discomfort), heart issues (heart disorder) and a echocardiogram was performed and stated she was going at 35 not 55-60 in her left ventricle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with ustekinumab was not reported. The outcome of the reduced vascularization in left hand, cut on hand with possible infection, headache, antiphospholipid syndrome, issue with back of calves and heart issues going at 35 not 55-60 in her left ventricle was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and antiphospholipid syndrome, reduced vascularization in left hand, heart issues going at 35 not 55-60 in her left ventricle, cut on hand with possible infection, issue with back of calves, and headache was related; between ustekinumab, and antiphospholipid syndrome, reduced vascularization in left hand, heart issues going at 35 and not 55-60 in her left ventricle, cut on hand with possible infection, issue with back of calves, and headache was related.  This report was serious (Other Medically Important Condition).  Additional information was received from patient on 11-OCT-2021. The following information was updated and incorporated into the case narrative: Added patient concomitant disease (high blood pressure, issue with abdominal cavity), event (antiphospholipid syndrome, calf discomfort, heart disorder), lab (echocardiogram) and causality and narrative updated.; Sender's Comments: V1: 20210904390-covid-19 vaccine ad26.cov2.s-antiphospholipid syndrome, reduced vascularization in left hand. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210904390-ustekinumab-antiphospholipid syndrome, reduced vascularization in left hand. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).