Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Prothrombin time, Pulmonary embolism, Pyrexia, Respiratory rate, SARS-CoV-2 antibody test
Clinical narrative: Acute Pulmonary Embolism; Fevers; chills; arthralgias; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Acute Pulmonary Embolism) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:     Concurrent medical conditions included Hypertension, Hyperlipidemia and Renal cell carcinoma.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Acute Pulmonary Embolism) (seriousness criteria hospitalization prolonged and medically significant), PYREXIA (Fevers), CHILLS (chills) and ARTHRALGIA (arthralgias). The patient was treated with APIXABAN for Drug therapy, at an unspecified dose and frequency and ENOXAPARIN (subcutaneous) for Anticoagulant therapy, at a dose of 1 mg/kg. At the time of the report, PULMONARY EMBOLISM (Acute Pulmonary Embolism), PYREXIA (Fevers), CHILLS (chills) and ARTHRALGIA (arthralgias) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: abnormal (abnormal) extensive multifocal pulmonary emboli involving both right and left lower lobe pulmonary  arteries with evidence of right ventricular strain. On an unknown date, Antiphospholipid antibodies: 27.1 mpl (Positive) antiphospholipid IgM antibodies were weakly positive and 10.7 s (Positive) The StaClot LA assay was borderline positive, suggesting the possible presence of LA.. On an unknown date, Blood count: normal (normal) normal. On an unknown date, Blood pressure measurement: 138/84 mmhg (normal) Normal. On an unknown date, Blood urea: 17 mg/dl (Inconclusive) 17. On an unknown date, Body temperature: 36.8 degrees celsius (normal) the patient's vital signs were normal with a temperature of 36.8 degrees Celsius. On an unknown date, C-reactive protein: 38.2 mg/l (Inconclusive) elevated. On an unknown date, Computerised tomogram: (Inconclusive) CT scan of the abdomen and pelvis without contrast demonstrated no acute intraabdominal process, including no evidence of recurrent RCC.. On an unknown date, Fibrin D dimer: 3840ng/ml feu (abnormal) 3840. On an unknown date, Glomerular filtration rate: 77 ml/min/bsa (Inconclusive) 77. On an unknown date, Heart rate: 65 (normal) Normal. On an unknown date, International normalised ratio: 1.2 (Inconclusive) The patients international normalized ratio (INR) were mildly prolonged and corrected when mixed 50:50 with normal pooled plasma, consistent with a possible factor deficiency. On an unknown date, Oxygen saturation: 97% (normal) 97 on room air. On an unknown date, Prothrombin time: 1.7 (abnormal) 1:50 ratio, 1.7 (abnormal) 1:500 ratio and 14.0 s (Inconclusive) The patients prothrombin time (PT) were mildly prolonged and corrected when mixed 50:50 with normal pooled plasma, consistent with a possible factor deficiency. On an unknown date, Respiratory rate: 17 (normal) Normal. On an unknown date, SARS-CoV-2 antibody test: >2500 u/ml (Positive) SARS-CoV-2 spike antibodies were strongly positive, consistent with robust vaccine-induced immunity but no history of COVID-19.. On an unknown date, White blood cell count: 9.2 × 109/l (Inconclusive) 9.2 × 109.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PULMONARY EMBOLISM (Acute Pulmonary Embolism), PYREXIA (Fevers), CHILLS (chills) and ARTHRALGIA (arthralgias) to be possibly related.    Concomitant medications were not provided by the reporter.  Patient was in his usual state of health until he received his second dose of the Moderna SARS-CoV-2 vaccine dose 10 days prior. 24 hours after the immunization he experienced fevers, chills, and arthralgias that transitioned to progressive right-sided flank pain and pleuritic chest pain. The patient was transitioned to apixaban for anticoagulation and discharged instable condition with hematology follow up.  Treatment information was not provided for fever, chills and arthralgia.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received by safety 27-Aug-2021 included an Email with FTA received from SARA team and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.