Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Deep vein thrombosis, Nausea, Nodule, Pain in extremity
Clinical narrative: DVT blood clot from the vaccine; lost 10 lbs that I can not afford to lose, 105 lbs now; Anxiety; pain in my legs; itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm; feeling nauseous; lump on the underside of her biceps; arm sore all day at the injection site and the next day she couldn't even lift it up; Arm sore at the injection site, couldn't lift up arm; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine) in a 63-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.     Concurrent medical conditions included Iodine allergy. Concomitant products included CLONAZEPAM for Anxiety, CITALOPRAM and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm sore at the injection site, couldn't lift up arm). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore all day at the injection site and the next day she couldn't even lift it up). On 25-Mar-2021, the patient experienced NODULE (lump on the underside of her biceps), RASH PRURITIC (itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm) and NAUSEA (feeling nauseous). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine) (seriousness criterion medically significant), WEIGHT DECREASED (lost 10 lbs that I can not afford to lose, 105 lbs now), ANXIETY (Anxiety) and PAIN IN EXTREMITY (pain in my legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine), WEIGHT DECREASED (lost 10 lbs that I can not afford to lose, 105 lbs now), ANXIETY (Anxiety), NODULE (lump on the underside of her biceps), PAIN IN EXTREMITY (arm sore all day at the injection site and the next day she couldn't even lift it up), PAIN IN EXTREMITY (pain in my legs), RASH PRURITIC (itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm), VACCINATION SITE PAIN (Arm sore at the injection site, couldn't lift up arm) and NAUSEA (feeling nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken by the patient included steroid injection for her back.  On an unknown date, the patient stated they had been to the hospital three separate times after receiving their first Moderna COVID-19 vaccine. While in the emergency room (ER) the patient suggested they do an ultrasound of the beet red, swollen, hot and itchy lump of the left arm. The ultrasound was performed and confirmed the patient had a deep vein thrombosis (DVT). It was recommended the patient had a scan of her lungs. However, the patient had an allergy to iodine and the hospital at that time did not have a machine that could perform such scan. The patient was transferred to a new hospital to have the scan performed. The unspecified scan of the lungs did not show any clots.   On an unknown date, the patient reported going back to the hospital on two separate occasions for pain in the legs. An ultrasound was performed and confirmed no clots in the legs. The patient reported fear and anxiety after experiencing the DVT.  This case concerns a 63-year-old female with a serious unexpected event of deep vein thrombosis, and nonserious weight decreased, anxiety, nodule, pain in extremity, rash pruritic, and vaccination site pain. Event latency within 24 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Case Upgraded to Serious. Added lab data which includes Ultrasound. Added allergy to iodine. Added new events DVT blood clot from the vaccine, weight loss and anxiety.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of deep vein thrombosis, and nonserious weight decreased, anxiety, nodule, pain in extremity, rash pruritic, and vaccination site pain. Event latency within 24 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.