Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiolipin antibody, Pain, Thrombosis, Ultrasound scan
Clinical narrative: Pain/pain when rise in morning as well as at night; Thrombosis leg/Blood clot in left calf; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis leg/Blood clot in left calf) in a 59-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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 July 2021, the patient experienced THROMBOSIS (Thrombosis leg/Blood clot in left calf) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain/pain when rise in morning as well as at night). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Thrombosis leg/Blood clot in left calf) and PAIN (Pain/pain when rise in morning as well as at night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Ultrasound scan: Inch long blood clot in left calf. On an unknown date, Cardiolipin antibody: (Positive) Positive, anticardio testing came back weird.         It was reported that on unknown dates, the patient experienced pain when rise in morning as well as at night and anticardio testing came back weird. In July 2021, the patient experienced  blood clot in left calf. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  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 spontaneous case concerns a 59  year  old, female patient, in treatment with Adalimumab for Rheumatoid arthritis, who experienced the unexpected, serious medically significant of thrombosis approximately 5 months after the second dose of mRNA  1273 vaccine. Approximately 6 months after vaccination, on ultrasound, an inch- long blood clot was reported in the left calf. Laboratory test revealed positive anticardiolipin antibodies which could be related with the event (date not provided). The patient was treated with Apixaban. No further details were provided for medical reviewing. Rheumatoid arthritis and co  suspect products Adalimumab, could be contributing factors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 59  year  old, female patient, in treatment with Adalimumab for Rheumatoid arthritis, who experienced the unexpected, serious medically significant of thrombosis approximately 5 months after the second dose of mRNA  1273 vaccine. Approximately 6 months after vaccination, on ultrasound, an inch- long blood clot was reported in the left calf. Laboratory test revealed positive anticardiolipin antibodies which could be related with the event (date not provided). The patient was treated with Apixaban. No further details were provided for medical reviewing. Rheumatoid arthritis and co  suspect products Adalimumab, could be contributing factors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.