Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur, Thrombosis, Vaccination site discharge
Clinical narrative: developed blood clots on his left arm where the vaccine was inserted/bloods clots (elongated/oval) the size of a dime to the size of a quarter; a white marble-like pattern running from the elbow down/pattern of a white marble-like substance under my skin/he experienced white traces under his skin that looks a marble and goes to different directions/white fat like substance under the skin; heart murmur; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (developed blood clots on his left arm where the vaccine was inserted/bloods clots (elongated/oval) the size of a dime to the size of a quarter) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2024, the patient experienced VACCINATION SITE DISCHARGE (a white marble-like pattern running from the elbow down/pattern of a white marble-like substance under my skin/he experienced white traces under his skin that looks a marble and goes to different directions/white fat like substance under the skin) and CARDIAC MURMUR (heart murmur). On an unknown date, the patient experienced THROMBOSIS (developed blood clots on his left arm where the vaccine was inserted/bloods clots (elongated/oval) the size of a dime to the size of a quarter) (seriousness criterion medically significant). The patient was treated with Apixaban (Eliquis) for Anticoagulant therapy, at a dose of 5 mg morning and night. At the time of the report, THROMBOSIS (developed blood clots on his left arm where the vaccine was inserted/bloods clots (elongated/oval) the size of a dime to the size of a quarter), VACCINATION SITE DISCHARGE (a white marble-like pattern running from the elbow down/pattern of a white marble-like substance under my skin/he experienced white traces under his skin that looks a marble and goes to different directions/white fat like substance under the skin) and CARDIAC MURMUR (heart murmur) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medications were reported.  The patient reported that, he was one of the first to get the Moderna vaccine at CVS for COVID-19 and 2 months after the vaccine, he developed blood clots on his left arm. In 2024, he then developed the white fat like substance under the skin (left arm only). In addition, reported a heart murmur that started at the beginning of 2024 and was put on blood thinners (Eliquis 5 mg morning and night) perhaps to reduce the blood clots. It took a while for those things to show themselves. Now the doctor wanted to place a stent on his heart and reporter was scheduled but eventually patient cancelled the appointment as the stent would create more problem. Patient was not unable to find his vaccination cards.  It was unknown if the patient had experienced any additional symptoms/events.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2024: Live follow up received contains non-significant information included reporter details updated, and reference number added. On 16-Dec-2024: Live significant follow up received included reporter details and patient details updated, events added, event verbatim updated, medical history added, reference number added and narrative updated. On 16-Dec-2024: Live follow-up received included reporter details updated, reference number added, and narrative updated. On 17-Dec-2024: Live follow-up received contains significant information included product details and reference numbers added.; Reporter's Comments: Concurrent medical condition  AFib is a contributor for event thrombosis. In view of the long non-suggestive onset latency the causality of the event "heart murmur"  was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.