Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: pulmonary embolism, right upper lobe [of lung], medial basal segment of the right lower lobe, lingula of the left upper lobe,medial basal and posterior segments of the left lower lobe; moderate pulmonary hypertension; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot), PULMONARY EMBOLISM (pulmonary embolism, right upper lobe [of lung], medial basal segment of the right lower lobe, lingula of the left upper lobe,medial basal and posterior segments of the left lower lobe) and PULMONARY HYPERTENSION (moderate pulmonary hypertension) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 016M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism, right upper lobe [of lung], medial basal segment of the right lower lobe, lingula of the left upper lobe,medial basal and posterior segments of the left lower lobe) (seriousness criterion medically significant) and PULMONARY HYPERTENSION (moderate pulmonary hypertension) (seriousness criterion medically significant). In November 2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) ongoing from 14-Nov-2021 for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot), PULMONARY EMBOLISM (pulmonary embolism, right upper lobe [of lung], medial basal segment of the right lower lobe, lingula of the left upper lobe,medial basal and posterior segments of the left lower lobe) and PULMONARY HYPERTENSION (moderate pulmonary hyperte89nsion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Chest X-ray: it came back clear (normal) it came back clear.. On 14-Nov-2021, Computerised tomogram: abnormal (abnormal) found that she had a blood clot, a pulmonary embolism, in the right upper lobe of her lung and others in the lingula of the left upper lobe, medial basal segment of the right lower lobe, medial basal and posterior segments of the left lower lobe, and moderate pulmonary hypertension.. On an unknown date, Fibrin D dimer: high (High) High.         It was reported the patient would like to report that she had some side effects from the Moderna booster. She had severe difficulty breathing about a week after taking the Moderna booster. She went to see her gastro doctor on 03 Nov 2021, who told her to see her regular doctor. She states she has not had asthma in 40 years. She tried her rescue inhaler, but it made it worse. The patient went to the emergency room on 14 Nov 2021. The patient was put on Xarelto blood thinner starter pack for one month, then she will take a regular pack for 6 months total. The patient started taking Xarelto on 14 Nov 2021. The difficulty breathing interrupted her life with doing anything she moved slow.  She would had a severe breathing issue, she would call it honking, if she went at a regular pace. Consent declined for safety to contact the patient HCP.  Company comment This spontaneous  case concerns a 71-year-old female patient with relevant medical history who experienced serious unexpected events of thrombosis, pulmonary embolism and pulmonary hypertension. The events started occurring approximately a week after the thuird, booster dose of the Moderna COVID-19 vaccine. Initially, the patient experienced dyspnea and used her asthma inhaler but the symptom did not resolve , it worsened. The patient had a chest X-ray which was unremarkable. Afterwards, the patient went to ER where they've diagnosed her with pulmonary embolism due to blood clot, and pulmonary hypertension. The patient received rivaroxaban as a corrective treatment. At the time of the report, outcome was unknown.  The rechallenge was not applicable since the event occurred after the booster dose so, no rechallenge was done and recurrence was not applicable.  Patient's advanced age is a possible confounder. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous  case concerns a 71-year-old female patient with relevant medical history who experienced serious unexpected events of thrombosis, pulmonary embolism and pulmonary hypertension. The events started occurring approximately a week after the thuird, booster dose of the Moderna COVID-19 vaccine. Initially, the patient experienced dyspnea and used her asthma inhaler but the symptom did not resolve , it worsened. The patient had a chest X-ray which was unremarkable. Afterwards, the patient went to ER where they've diagnosed her with pulmonary embolism due to blood clot, and pulmonary hypertension. The patient received rivaroxaban as a corrective treatment. At the time of the report, outcome was unknown.  The rechallenge was not applicable since the event occurred after the booster dose so, no rechallenge was done and recurrence was not applicable.  Patient's advanced age is a possible confounder. The benefit-risk relationship of drug is not affected by this report.