Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial test, Basophil count, Blood albumin, Blood cholesterol, Blood creatinine
Clinical narrative: Empyema; Complicated pleural effusion; This literature-non-study case was reported in a literature article and describes the occurrence of EMPYEMA (Empyema) and PLEURAL EFFUSION (Complicated pleural effusion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMPYEMA (Empyema) (seriousness criteria hospitalization and medically significant) and PLEURAL EFFUSION (Complicated pleural effusion) (seriousness criterion hospitalization). The patient was treated with CEFTRIAXONE at an unspecified dose and frequency; AZITHROMYCIN at an unspecified dose and frequency and PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (PIPERACILLIN/TAZOBACTAM) at an unspecified dose and frequency. At the time of the report, EMPYEMA (Empyema) and PLEURAL EFFUSION (Complicated pleural effusion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: unyielding. On an unknown date, Basophil count: 0. On an unknown date, Blood albumin (3.5-5.0 g/dL): 2.6 g/dL On Admission and 4.2 g/dL after 2 months. On an unknown date, Blood cholesterol: Cholesterol, body fluid was 93. On an unknown date, Blood creatinine: 1.4 mg/dl elevated, from a normal baseline. On admission.  Less than 1 mg/dl and 0.9 mg/dl after 2 months  Less than 1 mg/dl. On an unknown date, Blood culture: Negative. On an unknown date, Blood glucose: less than 10 mg/dl, very low. On an unknown date, Blood lactate dehydrogenase: 3.728 international unit per litre elevated. On an unknown date, Blood potassium (3.5-5.0 millimole per litre): 2.9 millimole per litre Hypokalemia, on admission and 4.5 millimole per litre after 2 months. On an unknown date, Blood sodium (135-145 millimole per litre): 130 millimole per litre hyponatremia, on admission and 135 millimole per litre after 2 months. On an unknown date, Blood triglycerides: 53. On an unknown date, Chest X-ray: showed large left lower lobe opacity with obliteration of the costophrenic angle suggestive of pleural effusion. Also, progression of the left-sided opacity was observed., Follow-up chest x-ray revealed worsening pleural effusion despite appropriate treatment. and post-VATS chest X-ray showed the resolution of left-sided pleural effusion.. On an unknown date, Computerised tomogram thorax: showed a left-sided pleural effusion with no visible pulmonary parenchymal infiltrate/consolidation. Also, left-sided posterior fluid collection observed.. On an unknown date, Culture: unyielding. On an unknown date, Cytology: Negative. On an unknown date, Echocardiogram: Showing fluid collection adjacent to the heart suggests pleural effusion.. On an unknown date, Electrocardiogram: unremarkable.. On an unknown date, Eosinophil count: 0. On an unknown date, Fungal test: unyielding. On an unknown date, Gram stain: unyielding. On an unknown date, Haemoglobin (13-16 g/dL): 12.6 g/dL On admission and 11.2 g/dL after 2 months. On an unknown date, Heart rate: 118 heart beats per minute tachycardic. On an unknown date, Lymphocyte count: 1. On an unknown date, Monocyte count: 0. On an unknown date, Mycobacterium test: unyielding. On an unknown date, Neutrophil count: 99. On an unknown date, Oxygen saturation: 85 % hypoxic, on room air. On an unknown date, Physical examination: significant for diminished breath sounds over the left lower third of the lung field with decreased vocal fremitus and dull percussion note. Otherwise, the physical exam was unremarkable. On an unknown date, Platelet count (150-400 10 thousand cells per microlitre): 214 10 thousand cells per microlitre and 345 10 thousand cells per microlitre. On an unknown date, Protein total: 4.6 mg/dl elevated, 5.8 gram per litre and 7.3 gram per litre. On an unknown date, Red blood cell count: 2000. On an unknown date, Respiratory rate: 25 cycles per minute, tachypneic. On an unknown date, Respiratory viral panel: unyielding. On an unknown date, Ultrasound scan: showed pleural effusion on the left side with pulmonary parenchymal echogenicity. and revealed a complex effusion with multiple thick loculations.. On an unknown date, White blood cell count (4-10 10 thousand cells per microlitre): 26 10 thousand cells per microlitre Leukocytosis, on admission, 6.4 10 thousand cells per microlitre after 2 months and 17584 cells per millilitre very high. On an unknown date, pH body fluid: 7.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EMPYEMA (Empyema) and PLEURAL EFFUSION (Complicated pleural effusion) to be related.    No concomitant or treatment medications were reported.  The patient presented to the emergency department during the summer with a one-week history of pleuritic chest pain, cough, and shortness of breath. He could not recall any preceding event or symptoms except that these symptoms started two days after receiving the Moderna Covid-19 booster.  The patient had hypoxia was correctable with supplementary oxygen therapy at 2 liters. However, he was afebrile with stable blood pressure on arrival. He was admitted to the hospital for a presumed diagnosis of community-acquired pneumonia. Diagnostic thoracentesis was pursued and yielded 200 ml of serosanguineous fluid, and antibiotics were broadened to Piperacillin-tazobactam.  The author concluded that the association between these occurrences and COVID-19 vaccines cannot be ascertained, but the temporal relationship and the lack of other identifiable causes maintain plausibility.  Given the lack of response with broad-spectrum antibiotics, the lack of evidence of infection by cultures, and the multiloculated nature of pleural effusion, the decision was to proceed with video-assisted thoracoscopic decortication (VATS). This has yielded 1100 ml of serosanguineous exudate. Chest tube output was and allowed the drainage of a further 250 ml of serosanguinous fluid in the first 12 hours postoperatively. However, afterward, drainage was minimal. The tube was removed three days afterward. Repeat chest x-ray after removal of chest tube revealed resolution of the effusion (Figure 5). No evidence of recurrence of pleural effusion was noted during follow-up a few months later.  Company Comment: This is a literature case concerning a 78 years-old male patient with no medical history reported, who experienced the unexpected serious (medically significant/hospitalization) event of empyema and unexpected serious (hospitalization) event of pleural effusion. The events occurred after a dose of mRNA-1273 vaccine. Patient complained of pleuritic chest pain, cough and shortness of breath after the vaccination. He was hypoxic with oxygen saturation of 85 % on room air, tachycardic with a heart rate of 118 beats per minute and with respiratory rate of 25. Hypoxia was corrected with 2 liters of oxygen. Blood tests showed leukocytosis, hyponatremia, hypokalemia, with evidence of acute kidney injury with elevated serum creatinine levels. Chest x-ray showed large lower lobe opacity with obliteration of the costophrenic angle. He was admitted to hospital for further investigation and treatment with Azithromycin and Ceftriaxone. EKG and echocardiography were unremarkable, bedside ultrasound showed pleural effusion on the left side. This was also demonstrated on the chest computer tomography. While hospitalized, a follow up x-rays showed worsening of the pleural effusion so diagnostic thoracocentesis was performed and antibiotics changed to Piperacillin-Tazobactam. Pleural fluid showed exudative fluid. Cytology and bacterial and blood cultures were negative.  No further information disclosed about diagnostic tests performed or treatments received. The author concluded that the association between these occurrences and COVID-19 vaccines cannot be ascertained, but the temporal relationship and the lack of other identifiable causes maintain plausibility. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2023: Live follow up received by safety on 23-MAY-2023 has Email with FTA and contains significant information: Literature citation details, Reporter information, Patient details, lab data, event added, seriousness criteria and narrative updated.; Reporter's Comments: This is a literature case concerning a 78 years-old male patient with no medical history reported, who experienced the unexpected serious (medically significant/hospitalization) event of empyema and unexpected serious (hospitalization) event of pleural effusion. The events occurred after a dose of mRNA-1273 vaccine. Patient complained of pleuritic chest pain, cough and shortness of breath after the vaccination. He was hypoxic with oxygen saturation of 85 % on room air, tachycardic with a heart rate of 118 beats per minute and with respiratory rate of 25. Hypoxia was corrected with 2 liters of oxygen. Blood tests showed leukocytosis, hyponatremia, hypokalemia, with evidence of acute kidney injury with elevated serum creatinine levels. Chest x-ray showed large lower lobe opacity with obliteration of the costophrenic angle. He was admitted to hospital for further investigation and treatment with Azithromycin and Ceftriaxone. EKG and echocardiography were unremarkable, bedside ultrasound showed pleural effusion on the left side. This was also demonstrated on the chest computer tomography. While hospitalized, a follow up x-rays showed worsening of the pleural effusion so diagnostic thoracocentesis was performed and antibiotics changed to Piperacillin-Tazobactam. Pleural fluid showed exudative fluid. Cytology and bacterial and blood cultures were negative.  No further information disclosed about diagnostic tests performed or treatments received. The author concluded that the association between these occurrences and COVID-19 vaccines cannot be ascertained, but the temporal relationship and the lack of other identifiable causes maintain plausibility. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.; Sender's Comments: This is a literature case concerning a 78 years-old male patient with no medical history reported, who experienced the unexpected serious (medically significant/hospitalization) event of empyema and unexpected serious (hospitalization) event of pleural effusion. The events occurred after a dose of mRNA-1273 vaccine. Patient complained of pleuritic chest pain, cough and shortness of breath after the vaccination. He was hypoxic with oxygen saturation of 85 % on room air, tachycardic with a heart rate of 118 beats per minute and with respiratory rate of 25. Hypoxia was corrected with 2 liters of oxygen. Blood tests showed leukocytosis, hyponatremia, hypokalemia, with evidence of acute kidney injury with elevated serum creatinine levels. Chest x-ray showed large lower lobe opacity with obliteration of the costophrenic angle. He was admitted to hospital for further investigation and treatment with Azithromycin and Ceftriaxone. EKG and echocardiography were unremarkable, bedside ultrasound showed pleural effusion on the left side. This was also demonstrated on the chest computer tomography. While hospitalized, a follow up x-rays showed worsening of the pleural effusion so diagnostic thoracocentesis was performed and antibiotics changed to Piperacillin-Tazobactam. Pleural fluid showed exudative fluid. Cytology and bacterial and blood cultures were negative.  No further information disclosed about diagnostic tests performed or treatments received. The author concluded that the association between these occurrences and COVID-19 vaccines cannot be ascertained, but the temporal relationship and the lack of other identifiable causes maintain plausibility. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.