Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Surgery, Thrombosis
Clinical narrative: Thrombosis leg; SURGERY; 10 May 2021,patient received 1st dose COVID-19 vaccine Moderna , 10 Sep 2021, patient received 2nd dose COVID-19 Vaccine moderna; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis leg) and SURGERY (SURGERY) in a 69-year-old female 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 ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    The patient's past medical history included Clot blood. Concurrent medical conditions included Crohn's disease and Ulcerative colitis. Concomitant products included HEPARIN for Clot blood.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced SURGERY (SURGERY) (seriousness criterion hospitalization). On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (Thrombosis leg) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (10 May 2021,patient received 1st dose COVID-19 vaccine Moderna , 10 Sep 2021, patient received 2nd dose COVID-19 Vaccine moderna). At the time of the report, THROMBOSIS (Thrombosis leg) had not resolved and SURGERY (SURGERY) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (10 May 2021,patient received 1st dose COVID-19 vaccine Moderna , 10 Sep 2021, patient received 2nd dose COVID-19 Vaccine moderna) outcome was unknown.            Treatment medication was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of surgery was not provided. the reporter's causality for the event(s) of blood clot in leg with humira(adalimumab) was no reasonable possibility.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 69-year-old female patient, with medical history of blood clots and current medical conditions of Crohn's disease and Ulcerative colitis treated with Adalimumab, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 4 months between doses and approximately 2 months after last dose she had a surgery that required hospitalization. As patient had history of blood clots, she was treated with Heparin while she was hospitalized. Additionally, 3 months after second vaccination, patient experienced medically significant event of leg thrombosis (AESI). No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical history of blood clots, surgery and hospitalization are risk factors for leg thrombosis. Regarding co-suspect product Adalimumab, it could be a contributory factor for leg thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 69-year-old female patient, with medical history of blood clots and current medical conditions of Crohn's disease and Ulcerative colitis treated with Adalimumab, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 4 months between doses and approximately 2 months after last dose she had a surgery that required hospitalization. As patient had history of blood clots, she was treated with Heparin while she was hospitalized. Additionally, 3 months after second vaccination, patient experienced medically significant event of leg thrombosis (AESI). No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical history of blood clots, surgery and hospitalization are risk factors for leg thrombosis. Regarding co-suspect product Adalimumab, it could be a contributory factor for leg thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.