Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration, Thrombosis
Clinical narrative: BLOOD CLOTS; COVID-19; COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (BLOOD CLOTS) in a 56-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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced THROMBOSIS (BLOOD CLOTS) (seriousness criteria hospitalization and medically significant), the first episode of COVID-19 (COVID-19) and the second episode of COVID-19 (COVID-19). The patient was hospitalized on sometime in September 2021 due to THROMBOSIS. At the time of the report, THROMBOSIS (BLOOD CLOTS) had resolved, last episode of COVID-19 (COVID-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. No concomitant medication was reported. The patient was recovering from her second case of covid 19. She was hospitalized due to blood clots in Sep 2021.  It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment information was provided.  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, concerning a 56-year-old female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Thrombosis, and the unexpected and non-serious AESI of COVID-19 (2 episodes reported), which occurred related to primary vaccination with mRNA-1273 vaccine. Co-suspect product includes non-company product Upadacitinib for rheumatoid arthritis. Patient was hospitalized approximately 6 months after the second dose of mRNA-1273 vaccine, due to blood clots. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, one episode of COVID-19 and Thrombosis had resolved, and other episode of COVID-19 was resolving. Underlying rheumatoid arthritis can be a confounder for 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, concerning a 56-year-old female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Thrombosis, and the unexpected and non-serious AESI of COVID-19 (2 episodes reported), which occurred related to primary vaccination with mRNA-1273 vaccine. Co-suspect product includes non-company product Upadacitinib for rheumatoid arthritis. Patient was hospitalized approximately 6 months after the second dose of mRNA-1273 vaccine, due to blood clots. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, one episode of COVID-19 and Thrombosis had resolved, and other episode of COVID-19 was resolving. Underlying rheumatoid arthritis can be a confounder for Thrombosis. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.