Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Musculoskeletal stiffness, Pulmonary embolism
Clinical narrative: Joint stiffness/stiff in left wrist; Musculoskeletal stiffness/stiff in right thigh and neck; two blood clots in right lung caused by the covid 19 vaccination/Pulmonary thrombosis; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (two blood clots in right lung caused by the covid 19 vaccination/Pulmonary thrombosis) in a 64-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-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) UNK. In December 2021, the patient experienced PULMONARY EMBOLISM (two blood clots in right lung caused by the covid 19 vaccination/Pulmonary thrombosis) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT STIFFNESS (Joint stiffness/stiff in left wrist) and MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness/stiff in right thigh and neck). At the time of the report, PULMONARY EMBOLISM (two blood clots in right lung caused by the covid 19 vaccination/Pulmonary thrombosis), JOINT STIFFNESS (Joint stiffness/stiff in left wrist) and MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness/stiff in right thigh and neck) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  the reporter's causality for humira(adalimumab) for the event(s) of two blood clots in right lung caused by the covid 19 vaccination with humira(adalimumab) was no reasonable possibility. For the event(s) of stiff in left wrist and stiff in right thigh and neck was not provided. the other RA opinion is that the event of two blood clots in right lung caused by the covid 19 vaccination is not assessable. RA opinion is that there is no reasonable possibility that the events of stiff in left wrist and stiff in right thigh and neck are related to humira(adalimumab).  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 64-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced medically significant event of pulmonary embolism (AESI) approximately 8 months after the last dose. It was reported that this event was caused by the covid-19 vaccination. Treatment included blood thinners. In addition, on an unknown date, patient experienced non serious events of joint and musculoskeletal stiffness. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent condition of Rheumatoid arthritis could be a contributory factor for joint and musculoskeletal stiffness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case reported by a consumer. A 64-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced medically significant event of pulmonary embolism (AESI) approximately 8 months after the last dose. It was reported that this event was caused by the covid-19 vaccination. Treatment included blood thinners. In addition, on an unknown date, patient experienced non serious events of joint and musculoskeletal stiffness. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent condition of Rheumatoid arthritis could be a contributory factor for joint and musculoskeletal stiffness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.