Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism in right lung/ Got very ill/ Almost died; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism in right lung/ Got very ill/ Almost died) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 004M20A and 039K20A) for COVID-19 prophylaxis.     Patient had no allergies.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism in right lung/ Got very ill/ Almost died) (seriousness criteria hospitalization and medically significant). The patient was treated with TPA at an unspecified dose and frequency and HEPARIN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism in right lung/ Got very ill/ Almost died) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication also include oral anticoagulants.  Company comment: This spontaneous case concerns a 67-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant, hospitalized) of Pulmonary embolism (reported as Pulmonary embolism in right lung/got very ill/almost died) that occurred unknown days after receiving the third dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Latency could not be assessed as the onset date of the event was not available. Patient had also received first and second dose of Moderna vaccine at an interval of 28 days. Patient was treated with,TPA(alteplase), Heparin and oral anticoagulants. No further information regarding risk factors, concurrent condition, concomitant medication, medical history, investigations and additional treatment details were provided. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 67-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant, hospitalized) of Pulmonary embolism (reported as Pulmonary embolism in right lung/got very ill/almost died) that occurred unknown days after receiving the third dose of mRNA-1273 vaccine in the Covid-19 vaccination series. Latency could not be assessed as the onset date of the event was not available. Patient had also received first and second dose of Moderna vaccine at an interval of 28 days. Patient was treated with TPA(alteplase), Heparin and oral anticoagulants. No further information regarding risk factors, concurrent condition, concomitant medication, medical history, investigations and additional treatment details were provided. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.