Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Echocardiogram, Electrocardiogram, Pulmonary embolism
Clinical narrative: Multiple Pulmonary Embolism -extreme pain left shoulder,back& short of breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Multiple Pulmonary Embolism -extreme pain left shoulder,back& short of breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced PULMONARY EMBOLISM (Multiple Pulmonary Embolism -extreme pain left shoulder,back& short of breathing) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-Oct-2021 to 25-Oct-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Adverse event, at a dose of Blood thinner. At the time of the report, PULMONARY EMBOLISM (Multiple Pulmonary Embolism -extreme pain left shoulder,back& short of breathing) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Negative for cardiac issues/normal. On an unknown date, Computerised tomogram: Positive for multiple bilateral pulmonary embolisms. On an unknown date, Echocardiogram: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative for cardiac issues. On an unknown date, Ultrasound Doppler: negative for embolism (Negative) Negative for embolism.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient denies acute illnesses at the time of vaccination. Patient does not suffer from chronic or long-standing health conditions.   CT scan was was positive for multiple bilateral pulmonary embolisms, a doppler of her legs was negative for embolism, an echocardiogram was also negative. She was prescribed ELIQUIS and discharged from hospital on 25-Oct-2021.She was seen by her primary MD on 29-Oct-2021, she was unable to determine the cause of PE, also have seen her hematologist, oncologist who indicated that all of the blood work was normal.  Discomfort was reported as residual effect.  Patient stated that exactly 2 weeks after she was diagnosed with PE, her brother was diagnosed with pulmonary embolism. Her brother also received Moderna vaccine.   Company comment: This is a spontaneous case concerning a  63-year-old female patient without chronic or long-standing health conditions, who experienced unexpected event of pulmonary embolism (seriousness criteria hospitalization and medically significant). The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. Patient was admitted to the hospital on 24-Oct-2021, due to shortness of breath and extreme pain in her left shoulder and back. Blood work and ECG ruled out cardiac issues. CT scan showed multiple bilateral pulmonary embolisms. Doppler of her legs and echocardiogram were reported as negative. She was prescribed Apixaban and discharged from hospital on 25-Oct-2021. Hematologist indicated that all of the blood work was normal. Patient stated that exactly 2 weeks after she was diagnosed with PE, her brother was diagnosed with pulmonary embolism. Her brother also received Moderna vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: The follow up document was received and Added patient demographics, lab data, hospital discharged date, some information in I-narrative supplement and updated event verbatim.; Sender's Comments: This is a spontaneous case concerning a  63-year-old female patient without chronic or long-standing health conditions, who experienced unexpected event of pulmonary embolism (seriousness criteria hospitalization and medically significant). The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. Patient was admitted to the hospital on 24-Oct-2021, due to shortness of breath and extreme pain in her left shoulder and back. Blood work and ECG ruled out cardiac issues. CT scan showed multiple bilateral pulmonary embolisms. Doppler of her legs and echocardiogram were reported as negative. She was prescribed Apixaban and discharged from hospital on 25-Oct-2021. Hematologist indicated that all of the blood work was normal. Patient stated that exactly 2 weeks after she was diagnosed with PE, her brother was diagnosed with pulmonary embolism. Her brother also received Moderna vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.