Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax, High-resolution computerised tomogram of lung, Pulmonary embolism
Clinical narrative: multiple pulmonary emboli; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (multiple pulmonary emboli) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     The patient's past medical history included Renal cell carcinoma (treated surgically in January 2017.), Surgery (Renal Cell Carcinoma) in January 2017 and Nephrectomy. Concurrent medical conditions included Asthma, Diabetes, Blood pressure high and Chronic kidney disease.    On 03-Jul-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (multiple pulmonary emboli) (seriousness criteria hospitalization and medically significant). The patient was treated with CITRIC ACID MONOHYDRATE, GLUCOSE MONOHYDRATE, SODIUM CITRATE DIHYDRATE (ANTICOAGULANTE ACD) at a dose of 1 dosage form; HEPARIN (intravenous) at a dose of 1 dosage form and RIVAROXABAN (XARELTO) at a dose of 1 dosage form. At the time of the report, PULMONARY EMBOLISM (multiple pulmonary emboli) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2023, Computerised tomogram thorax: Chest CT- W IV CONTRAST  Acute appearing pulmonary emboli bilaterally The most proximal level involves the basal part of the inferior right lower lobe artery with extension into the segmental branches Suspected additional sub occlusive emboli within distal branches to the inferior right middle lobe, left upper lobe and left lung base No definite imaging evidence of acute heart strain or volume overload and no current evidence of pulmonary parenchymal infarcts Stable pre-existing pulmonarynodules. On an unknown date, High-resolution computerised tomogram of lung: Multiple Pulmonary Emboli in both lungs.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   On 7/27/2023, he had CT scans of my chest and abdomen as a follow up to Renal Cell Carcinoma. The radiologist called his physician to inform him that he had multiple pulmonary emboli in both lungs. He was asymptomatic. He was admitted to Hospital, where he received Heparin as an anticoagulant and was discharged the following day with a prescription for Zarelto. He does not know if the COVID vaccine caused this or if it was related to his previous cancer diagnosis.  Company comment: This is a regulatory case concerning a 72-year-old female patient with relevant medical history of Renal cell carcinoma (treated surgically in January 2017.), Surgery (Renal Cell Carcinoma) in January 2017 and Nephrectomy, Asthma, Diabetes, Blood pressure high and chronic kidney disease, who experienced the unexpected serious (medically significant and hospitalization) AESI of Pulmonary embolism. The patient received the sixth dose of mRNA-1273.222 (BA.4/BA.5) vaccine. It was reported that 20 days after the sixth dose, the patient had CT scans of chest and abdomen as a follow up to Renal Cell Carcinoma that was treated surgically in January 2017. The radiologist called his physician to inform him that I had multiple pulmonary emboli in both lungs. He was asymptomatic and was admitted to the Hospital, where he received Heparin as an anticoagulant and discharged the following day with a prescription for Xarelto (Apixaban). CT scan of lungs showed pulmonary emboli. No further clinical information was provided for review. The mentioned medical history of renal cell carcinoma could be a contributory factor for the event pulmonary embolism and the mentioned multiple comorbidities could be a confounder for the event. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report. Seriousness assessed as reported.