Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Deep vein thrombosis, Pulmonary embolism, Vaccination site pain, Vaccination site warmth
Clinical narrative: DVT and Pulmonary Emboli; DVT and Pulmonary Emboli; Covid arthritis.; they have had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore.; they have had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore.; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT and Pulmonary Emboli) and PULMONARY EMBOLISM (DVT and Pulmonary Emboli) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 004M20A and 028L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism (Caller has hypothyroidism, fibromyalgia.). Concurrent medical conditions included Allergy to antibiotic (Caller has allergies to antibiotics and NSAIDS. They are body sensitives), Allergy to NSAIDs (Caller has allergies to antibiotics and NSAIDS. They are body sensitives) and Fibromyalgia (Caller has hypothyroidism, fibromyalgia.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT and Pulmonary Emboli) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (DVT and Pulmonary Emboli) (seriousness criteria hospitalization and medically significant), ARTHRITIS (Covid arthritis.), VACCINATION SITE WARMTH (they have had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore.) and VACCINATION SITE PAIN (they have had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore.). The patient was treated with METHYLPREDNISOLONE in August 2021 for Arthritis, at a dose of 8 milligram once a day; METHYLPREDNISOLONE for Arthritis, at a dose of 6 milligram once a day and APIXABAN (ELIQUIS) for DVT and Pulmonary embolism, at an unspecified dose and frequency. In 2022, DEEP VEIN THROMBOSIS (DVT and Pulmonary Emboli) and PULMONARY EMBOLISM (DVT and Pulmonary Emboli) had resolved. At the time of the report, ARTHRITIS (Covid arthritis.), VACCINATION SITE WARMTH (they have had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore.) and VACCINATION SITE PAIN (they have had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore.) outcome was unknown.            Patient had been with Moderna since they first started out.  Every time they got the initial and second booster, they had a very sore area, a very hot area, and it drained down to the elbow. The injection site was hot, hard, sore. Patient does not get a reaction when they had their flu shot or pneumonia shot.  Patient was on Eliquis for DVT and Pulmonary Emboli which they hopefully had resolved, last time in the hospital for it was 2022.  Doctor prescribed her Methylprednisolone 8mg daily in Aug2021 and currently on the 6mg. Patient was put on that because their rheumatologist at the time said they had a Covid arthritis. Concomitant medications were not reported. Company comment: This spontaneous case concerns a 78-year-old female patient, with  medical history  of fibromyalgia and hypothyroidism reported, who experienced the unexpected, serious (hospitalization, medically significant) events of Deep vein thrombosis (DVT) (AESI) and pulmonary embolism (AESI) and non-serious unexpected AESI of arthritis in context of vaccination with mRNA-1273; latency cannot be calculated due to events onset dates unknown. The patient was vaccinated with 3 doses of mRNA-1273; 1st and 2nd doses of vaccination were administered with 28 days interval and 3rd dose was administered app. 9,5 months after the 2nd dose. The patient was treated with Methylprednisolone app. 6 months after 2nd dose vaccination for Arthritis, at a dose of 8 milligram once a day; and with for DVT and Pulmonary embolism, at an unspecified dose and frequency. Underlying hypothyroidism and fibromyalgia are confounders for arthritis. Further details regarding clinical course, etiologic and diagnostic work-up and treatment are available for the review. Arthritis outcome was unknown while the rest of events were resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-751584, US-MODERNATX, INC.-MOD-2023-751596 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751584:Same patient different dose (SPIKEVAX 2023-2024) US-MODERNATX, INC.-MOD-2023-751596:Same patient different dose (SPIKEVAX NOS)