Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder fracture, Thrombosis
Clinical narrative: Broke her shoulder; she had a huge blood clot behind her left knee; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (she had a huge blood clot behind her left knee) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 037A21B, 036B21A and 059A22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced THROMBOSIS (she had a huge blood clot behind her left knee) (seriousness criterion medically significant). On an unknown date, the patient experienced SHOULDER FRACTURE (Broke her shoulder). The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (she had a huge blood clot behind her left knee) and SHOULDER FRACTURE (Broke her shoulder) was resolving.            No relevant concomitant medications were reported.  The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received fifth dose of Moderna on 20-Sep-2022 lot number AS7146B, sixth dose on 25-Sep-2023 and seventh dose on 20-Oct-2023. Patient was administered with the flu vaccine in between the 2 doses of the Spikevax. It was reported that after patient took the third dose of the vaccine in Oct2021, she went on vacation and broke her shoulders. After 3 days she flew back home. In Feb2022, it was when they found out that she had a huge blood clot behind her left knee.   Company Comment: This is a spontaneous case concerning a 62-year-old female patient with a history of an airplane flight after third dose of mRNA-1273 vaccine, who experienced the serious (due to medically significant) unexpected, AESI event of Thombosis.  The event occurred approximately 4 months after a dose of mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule. Patient also experienced the non-serious event of shoulder fracture. It was reported that after patient took the third dose of the vaccine in Oct2021, she went to Portugal and broke her shoulder. After 3 days she flew back to the United States. In Feb2022, it was when they found out that she had a huge blood clot behind her left knee. The patient was treated with Rivaroxaban. The outcome of the events was reported as recovering. Considering the described information, non-suggestive temporal relation, nature of event of shoulder fracture, along with medical history of airplane flight, causality is assessed as not related for both events. The mentioned medical history remains as a confounder for event thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-746937, MOD-2023-747238 (Patient Link).