Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac disorder, Computerised tomogram, Deep vein thrombosis, Dyspnoea
Clinical narrative: very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder; found two blood clots on lungs and two in legs; found two blood clots on lungs and two in legs; there was damaged to his wife's heart too; weighed165 pounds initially and then went down to 145; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) and CARDIAC DISORDER (there was damaged to his wife's heart too) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A2 or 078A2 and 028A2 or 078A2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing) (seriousness criterion hospitalization), ARTHRALGIA (pain in back of right shoulder) (seriousness criteria medically significant and life threatening), FATIGUE (very tired, slept all day) (seriousness criteria hospitalization, medically significant and life threatening), HYPERSOMNIA (slept all day) (seriousness criteria hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (there was damaged to his wife's heart too) (seriousness criterion hospitalization) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145). At the time of the report, DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs), CARDIAC DISORDER (there was damaged to his wife's heart too) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: two blood clots on lungs and two (abnormal) two blood clots on lungs and two in legs. On an unknown date, Weight: 145 (Low) weighed 165 pounds initially and then went down to 145.         The patient was hospitalized for around four days. The patient size of clots as 10 cm and 9cm in the lungs. The reporter stated that Heparin was used in the hospital and after the discharge the patient was put on Eliquis for the next 6 months. The reporter reported that the patient weighed165 pounds initially and then went down to 145 afterwards.   Action taken with the mRNA-1273 is considered as not applicable.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.