Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: acute NSTEMI; bronchopulmonary fistula; Positive for COVID-19 infection and bronchopulmonary fistula formation as a complication of COVID-19 pneumonia.; acute hypoxic failure; Positive for COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (acute NSTEMI), PULMONARY FISTULA (bronchopulmonary fistula), COVID-19 PNEUMONIA (Positive for COVID-19 infection and bronchopulmonary fistula formation as a complication of COVID-19 pneumonia.), ACUTE RESPIRATORY FAILURE (acute hypoxic failure) and COVID-19 (Positive for COVID-19 infection) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.       Concurrent medical conditions included Hypertension.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (acute NSTEMI) (seriousness criteria hospitalization and medically significant), PULMONARY FISTULA (bronchopulmonary fistula) (seriousness criteria hospitalization and medically significant), COVID-19 PNEUMONIA (Positive for COVID-19 infection and bronchopulmonary fistula formation as a complication of COVID-19 pneumonia.) (seriousness criteria hospitalization and medically significant), ACUTE RESPIRATORY FAILURE (acute hypoxic failure) (seriousness criteria hospitalization and medically significant) and COVID-19 (Positive for COVID-19 infection) (seriousness criterion hospitalization). The patient was treated with OXYGEN (nasal use) at a dose of 5L of low-flow on day 6; OXYGEN (nasal use) at a dose of 100% at 70L/min flow rate; HEPARIN (intravenous use) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN 81) (oral use) at a dose of 81 milligram once a day; ATORVASTATIN (oral use) at a dose of 40 milligram once a day; DEXAMETHASONE (oral use) at a dose of 6 milligram once a day; REMDESIVIR (intravenous use) at a dose of 100 milligram; BARICITINIB (oral use) at a dose of 4 milligram once a day and MIRTAZAPINE at a dose of 15 milligram at bedtime. At the time of the report, ACUTE MYOCARDIAL INFARCTION (acute NSTEMI), ACUTE RESPIRATORY FAILURE (acute hypoxic failure) and COVID-19 (Positive for COVID-19 infection) outcome was unknown and PULMONARY FISTULA (bronchopulmonary fistula) and COVID-19 PNEUMONIA (Positive for COVID-19 infection and bronchopulmonary fistula formation as a complication of COVID-19 pneumonia.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood bicarbonate (24-34 milliequivalent per litre): 20 milliequivalent per litre. On an unknown date, Blood creatinine (0.7-1.3 mg/dl): 1.4 mg/dl. On an unknown date, Blood lactate dehydrogenase: 2.6 millimole per litre. On an unknown date, Blood urea (8-20 milliequivalent per litre): 50 milliequivalent per litre. On an unknown date, Body temperature: 97.0 degree F. On an unknown date, Chest X-ray: Anterior-Posterior chest x-ray on admission showing diffuse ground glass and interstitial opacifications, worse on the left side, Anterior-Posterior chest x-ray showing worsening left-sided ground glass and interstitial opacifications and a right-sided pneumothorax on day 3., Anterior-Posterior chest x-ray with resolution of right-sided pneumothorax after placement of a 14 French pigtail catheter, chest x-ray showed a worsening right-sided pneumothorax, so the chest tube was placed back to suction., showed subcutaneous emphysema on day 16., Anterior-Posterior chest x-ray on postoperative day one showing no residual pneumothorax and improving atelectasis in the left lung spaces and right lung space with a right-sided chest tube., On postoperative day 11, no pneumothorax and Anterior-Posterior chest x-ray on the day of discharge twenty four hours after the patient's right-sided chest tube was removed with minor residual lower lung lobe atelectasis.. On an unknown date, Coagulation test: within normal limits. On an unknown date, Computerised tomogram: CT scan with IV contrast of the thorax showed extensive air pockets bilaterally, soft tissue emphysema, worsening right-sided consolidations, and a mild pneumothorax despite having a right-sided pleural catheter in place with the system on suction on day 16.. On an unknown date, Drug screen: (Negative) urine drug screen (Roche Diagnostics) was negative.. On an unknown date, Echocardiogram: unremarkable for structural and functional abnormalities. On an unknown date, Electrocardiogram: showed non-specific ST segment and T-wave changes.. On an unknown date, Haemoglobin (13-17 gram per decilitre): 12.8 gram per decilitre. On an unknown date, Heart rate: 90. On an unknown date, Influenza A virus test: (Negative) Influenza Type A polymerase chain reaction (PCR) test. On an unknown date, Influenza B virus test: (Negative) Influenza Type B polymerase chain reaction (PCR) test. On an unknown date, Oxygen saturation: 91-93%, 83 % hypoxic with peripheral oxygen saturation (SpO2) of 83% on room air. and 97 % on day 19 oxygen saturation had improved to 97% on 3L nasal cannula.. On an unknown date, Physical examination: the patient demonstrated increased work of breathing, and he was noted to have crackles and decreased breath sounds bilaterally on auscultation. and on day 16, chest wall crepitus was noted. On an unknown date, SARS-CoV-2 test: (Positive) patient's nasopharyngeal real-time reverse transcriptase PCR test for SARS-CoV-2 RNA. On an unknown date, Serum ferritin: 865.6 ng/mL. On an unknown date, Troponin I: 0.46 ng/mL elevated. On an unknown date, White blood cell count (4300-11000 cells per microlitre): 11900 cells per microlitre leukocytosis.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient presented with a three-day history of worsening rhinorrhea, cough, ageusia and anosmia, anorexia, headache, and generalized weakness.  On hospital day 3, new dyspnea and shortness of breath were observed. On hospital day 6, the patient's clinical condition appeared to stabilize. A chest tube clamp trial was performed, and the patient quickly decompensated with new-onset tachypnea, tachycardia, shortness of breath, and oxygen desaturation to 80%. On day 9 patient experienced generalized weakness, poor appetite, and endorsed feelings of depression. He reported difficulty swallowing, speaking, and increased difficulty eating, due to a combination of dryness in his throat, along with increased feelings of depression. He had feelings of loneliness due to seclusion from his family who were unable to visit because of COVID-19 isolation parameters. A persistent air leak was noted on the chest tube drainage system while the system was on suction. On day 19, air leak persisted from the chest tube, and attempts at clamping the chest tube or placing it on a water seal would cause a reoccurrence of his pneumothorax.  Patient underwent video-assisted thoracoscopic surgery with 8 grams of talc spread evenly throughout the parietal pleura for chemical pleurodesis and placement of a 32 French chest tube.  In the immediate postoperative period, the patient was doing well and had resolution of his pneumothorax while on 20 cm H2O of suction. On postoperative day (POD) 11, the chest tube was removed from suction and placed on a water seal. The patient continued to improve clinically, with improved appetite and caloric intake, increased participation with physical therapy, and resolving feelings of depression. By POD 16, the air leak had resolved, and the chest tube thus was removed. On POD 17, he was discharged to a skilled nursing facility. At next follow-up, he was at home and able to perform daily activities without difficulties.  Company comment: This literature non study case concerns a 77-year-old, male patient with medical history of hypertension, who experienced the unexpected serious (medically significant) AESI of acute respiratory failure and acute myocardial infarction (NSTEMI) and unexpected serious (medically significant) events of COVID 19, COVID 19 pneumonia and pulmonary fistula (bronchopulmonary fistula). The events occurred after the second dose of SPIKEVAX NOS. As reported, patient was positive for COVID-19 infection and had bronchopulmonary fistula formation as a complication of COVID-19 pneumonia. Patient was also found to have NSTEMI and experienced acute respiratory failure due to COVID 19. Patient's fistula was successfully managed by video assisted thoracoscopic surgery. Considering that all reported events can be explained by COVID 19 infection and COVID 19 pneumonia with underlying hypertension as additional risk factor for NSTEMI, the events are assessed as not related to SPIKEVAX NOS. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.