Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Pulmonary embolism
Clinical narrative: Moderna vaccine cause blood clots in her lungs/Blood clots in her lungs; Only taken 1 dose so far/Has not taken another dose; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Moderna vaccine cause blood clots in her lungs/Blood clots in her lungs) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CC9021A(4)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intubation (intubated where they stuck a tube down the throat into the lungs.). Concurrent medical conditions included Allergy to antibiotic (Erythromycin), Drug allergy (Wellbutrin), Penicillin allergy and Allergy to antibiotic (Amoxicillin).    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Moderna vaccine cause blood clots in her lungs/Blood clots in her lungs) (seriousness criteria hospitalization and medically significant) and INCOMPLETE COURSE OF VACCINATION (Only taken 1 dose so far/Has not taken another dose). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Moderna vaccine cause blood clots in her lungs/Blood clots in her lungs) and INCOMPLETE COURSE OF VACCINATION (Only taken 1 dose so far/Has not taken another dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by patient.  It was reported that Moderna vaccine caused blood clots in patient lungs and stated that she had only taken 1 dose so far and had not taken another dose. The patient stated that she was hospitalized for a week and was intubated where they stuck a tube down the throat into the lungs. Patient had no COVID positive test or diagnosis.  Company Comment: This spontaneous case concerns a 60-year-old, female patient, with no relevant medical history reported, who experienced an unexpected, medically significant AESI Pulmonary embolism (blood clots in her lungs) after receiving a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact latency of the event pulmonary embolism relative to vaccination cannot be determined with unknown event's onset date and hospitalization date. Patient received Eliquis as treatment. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Reportedly, the patient received only one dose of mRNA-1273 vaccine so far (incomplete course of vaccination). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 60-year-old, female patient, with no relevant medical history reported, who experienced an unexpected, medically significant AESI Pulmonary embolism (blood clots in her lungs) after receiving a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact latency of the event pulmonary embolism relative to vaccination cannot be determined with unknown event's onset date and hospitalization date. Patient received Eliquis as treatment. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Reportedly, the patient received only one dose of mRNA-1273 vaccine so far (incomplete course of vaccination). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.