Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Deep vein thrombosis, Dyspepsia, Hypersomnia
Clinical narrative: 3 blood clots in her right calf; very very weak; slept 20 hours a day, could not get out of bed; didn't eat very much at all; needed help getting to the bathroom; made me feel sick; heart burn; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (3 blood clots in her right calf) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second 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 (3 blood clots in her right calf) (seriousness criterion medically significant), ASTHENIA (very very weak), HYPERSOMNIA (slept 20 hours a day, could not get out of bed), DECREASED APPETITE (didn't eat very much at all), MOBILITY DECREASED (needed help getting to the bathroom), MALAISE (made me feel sick) and DYSPEPSIA (heart burn). The patient was treated with DABIGATRAN ETEXILATE MESILATE (PRADAXA) for Adverse event, at an unspecified dose and frequency; OMEPRAZOLE for Adverse event, at an unspecified dose and frequency and APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (3 blood clots in her right calf), ASTHENIA (very very weak), HYPERSOMNIA (slept 20 hours a day, could not get out of bed), DECREASED APPETITE (didn't eat very much at all), MOBILITY DECREASED (needed help getting to the bathroom), MALAISE (made me feel sick) and DYSPEPSIA (heart burn) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed. The patient took an x-ray which did not show anything. The patient was treated with Pradaxa for 4 weeks which gave her heart burn so she also took omeprazole which felt sick then switched to Eliquis for 2 weeks, for a total of 6 weeks on blood thinners. The patient foot was still swollen and hurting. The blood work and x-rays,  but could not find any problem.  The patient was given an orthopedic boot which didn't help and more blood work. She was at some point thought to have a bone infection in her foot and sent to the ER, where they said based upon lab work she did not have a bone infection.  This case concerns an 82-year-old female patient who experienced deep vein thrombosis,  asthenia, hypersomnia, decreased appetite, mobility decreased, malaise and dyspepsia following administration of mRNA-1273. Second dose latency was one nine days. Reportedly, the patient experienced dyspepsia and malaise after use of Pradaxa and omeprazole and thus, causality is assessed as unlikely. Causality for other events is assessed as possible based on the current available information and plausible temporal relationship, although confounded with patient's advanced age.; Sender's Comments: This case concerns an 82-year-old female patient who experienced deep vein thrombosis,  asthenia, hypersomnia, decreased appetite, mobility decreased, malaise and dyspepsia following administration of mRNA-1273. Second dose latency was one nine days. Reportedly, the patient experienced dyspepsia and malaise after use of Pradaxa and omeprazole and thus, causality is assessed as unlikely. Causality for other events is assessed as possible based on the current available information and plausible temporal relationship, although confounded with patient's advanced age.