Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Pulmonary embolism
Clinical narrative: had blood clots in the lung, in both lungs/went to the hospital they found blood clots, did a CAT scan and found blood clots; couldn't breath, had difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (had blood clots in the lung, in both lungs/went to the hospital they found blood clots, did a CAT scan and found blood clots) and DYSPNOEA (couldn't breath, had difficulty breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 048C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PULMONARY EMBOLISM (had blood clots in the lung, in both lungs/went to the hospital they found blood clots, did a CAT scan and found blood clots) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (couldn't breath, had difficulty breathing) (seriousness criterion hospitalization). The patient was hospitalized from 02-Dec-2021 to 04-Dec-2021 due to DYSPNOEA and PULMONARY EMBOLISM. The patient was treated with HEPARIN for Anticoagulant therapy, at an unspecified dose and frequency and APIXABAN (ELIQUIS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (had blood clots in the lung, in both lungs/went to the hospital they found blood clots, did a CAT scan and found blood clots) and DYSPNOEA (couldn't breath, had difficulty breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: blood clots (abnormal) found blood clots.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Company Comment: This case concerns a 63-year-old female patient, with no medical history, who experienced the unexpected serious events of Pulmonary embolism and Dyspnea. The events occurred on an unknown date after the third  dose of mRNA-1273 Vaccine that resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 63-year-old female patient, with no medical history, who experienced the unexpected serious events of Pulmonary embolism and Dyspnea. The events occurred on an unknown date after the third  dose of mRNA-1273 Vaccine that resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.