Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ankle fracture, Thrombosis
Clinical narrative: Patient broke her ankle; Found a small clot on the same site/a huge blood clot behind her left knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Found a small clot on the same site/a huge blood clot behind her left knee) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Thrombosis since February 2022.    On 20-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced ANKLE FRACTURE (Patient broke her ankle). In 2023, the patient experienced THROMBOSIS (Found a small clot on the same site/a huge blood clot behind her left knee) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) in 2023 for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Found a small clot on the same site/a huge blood clot behind her left knee) and ANKLE FRACTURE (Patient broke her ankle) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  After fifth vaccination the patient went on vacation in Apr-2023 and broke her ankle. A small clot was found behind left knee (same site of blood clot in Feb2022), when the patient returned 5-6 weeks later. The patient was treated with Xarelto. It was reported that, the patient did not have the usual redness and swelling which usually accompany blood clots.  Company comment: This spontaneous case concerns a female patient of unknown age, with medical history of thrombosis (a huge blood clot behind her left knee), who experienced the unexpected serious (medically significant) AESI of thrombosis and non serious event of ankle fracture. The events occurred approximately 7 months after the fifth dose of mRNA-1273 bivalent BA.4/BA.5. As reported, after fifth vaccination the patient went on vacation and broke her ankle. A small clot was found behind left knee (same site of blood clot in Feb2022), when the patient returned 5-6 weeks later. The patient was treated with Xarelto. It was reported that, the patient did not have the usual redness and swelling which usually accompany blood clots. No further information about the events was provided. Considering the described information, non suggestive temporal relation, nature of event of ankle fracture and it being the likely cause of blood clot along with prior medical history of the same condition causality is assessed as not related for both events. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to MOD-2023-747023 (Patient Link).