Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pulmonary embolism, Somnolence
Clinical narrative: shortness of breath and her heart was pounding/bilateral pulmonary emboli most likely occurred in her legs and traveled to her lungs; Slept most of the day; No appetite; Exhausted; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (shortness of breath and her heart was pounding/bilateral pulmonary emboli most likely occurred in her legs and traveled to her lungs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Platelet count low. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 04-Feb-2021, the patient experienced SOMNOLENCE (Slept most of the day), DECREASED APPETITE (No appetite), FATIGUE (Exhausted) and CHILLS (Chills). On 14-Aug-2021, the patient experienced PULMONARY EMBOLISM (shortness of breath and her heart was pounding/bilateral pulmonary emboli most likely occurred in her legs and traveled to her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 19-Aug-2021 to 21-Aug-2021 due to PULMONARY EMBOLISM. The patient was treated with HEPARIN for Pulmonary embolism, at an unspecified dose and frequency; APIXABAN (ELIQUIS) for Pulmonary embolism, at a dose of 10 mg twice a day and APIXABAN (ELIQUIS) ongoing since an unknown date for Pulmonary embolism, at a dose of 5 mg twice a day. On 05-Feb-2021, SOMNOLENCE (Slept most of the day), DECREASED APPETITE (No appetite), FATIGUE (Exhausted) and CHILLS (Chills) had resolved. At the time of the report, PULMONARY EMBOLISM (shortness of breath and her heart was pounding/bilateral pulmonary emboli most likely occurred in her legs and traveled to her lungs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was not diagnosed for idiopathic thrombocytopenic purpura but she a had a history of low platelets. She was a walker and not overweight. She was basically healthy. On 05/FEB/2021 she felt fine. The weekend of 14-AUG-2021 and 15-AUG-2021, she started with shortness of breath and her heart was pounding. She was referred her to the emergency room (ER). On 19-AUG-2021, she went to the ER and was found to have bilateral pulmonary emboli. It most likely occurred in her legs and traveled to her lungs. She was admitted, received a heparin infusion, and put on Eliquis. She was discharged on 21-AUG-2021 with Eliquis 10 mg 2Xday for one week, then 5 mg 2Xday. She had to follow up with a pulmonologist in a month and had to check in with hematology.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.