Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Echocardiogram, Inflammation, Interstitial lung disease, Muscle spasms
Clinical narrative: CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced; interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere; acute respiratory failure with hypoxia/dyspnea on exertion; possibility of an acute inflammatory response to her COVID-19 vaccination; restrictive lung disease; CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced; pulmonary fibrosis; diffuse cramping/leg cramps; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY FIBROSIS (pulmonary fibrosis), INTERSTITIAL LUNG DISEASE (interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere), BRONCHIECTASIS (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced), ACUTE RESPIRATORY FAILURE (acute respiratory failure with hypoxia/dyspnea on exertion), INFLAMMATION (possibility of an acute inflammatory response to her COVID-19 vaccination), RESTRICTIVE PULMONARY DISEASE (restrictive lung disease) and CONDITION AGGRAVATED (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker (at least 45 pack years) in January 2020, Anemia, Spinal operation (thoracic upper lumbar spine) and Cholecystectomy. Concurrent medical conditions included Penicillin allergy, Pulmonary fibrosis since 2016, Hypertension, GERD (without esophagitis), Chronic kidney disease stage 3 (stage 3b), Interstitial pneumonitis (idiopathic), Centrilobular emphysema, Bronchiectasis and Pancreatic atrophy (fatty atrophy on CT scan chest 04 Mar 2021). Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for GERD, CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]), CALCIUM, VITAMIN D3, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), FUROSEMIDE (LASIX [FUROSEMIDE]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) and TRAMADOL HYDROCHLORIDE (ULTRAM [TRAMADOL HYDROCHLORIDE]) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PULMONARY FIBROSIS (pulmonary fibrosis) (seriousness criteria hospitalization, disability and life threatening), RESTRICTIVE PULMONARY DISEASE (restrictive lung disease) (seriousness criteria hospitalization, disability and life threatening) and CONDITION AGGRAVATED (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced) (seriousness criteria hospitalization, disability and life threatening). In February 2021, the patient experienced ACUTE RESPIRATORY FAILURE (acute respiratory failure with hypoxia/dyspnea on exertion) (seriousness criteria hospitalization, disability and life threatening) and INFLAMMATION (possibility of an acute inflammatory response to her COVID-19 vaccination) (seriousness criteria hospitalization, disability and life threatening). On 18-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (diffuse cramping/leg cramps). On 24-Feb-2021, the patient experienced INTERSTITIAL LUNG DISEASE (interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere) (seriousness criteria hospitalization, disability and life threatening). On 04-Mar-2021, the patient experienced BRONCHIECTASIS (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized from 31-Mar-2021 to 06-Apr-2021 due to ACUTE RESPIRATORY FAILURE, BRONCHIECTASIS, CONDITION AGGRAVATED, INFLAMMATION, INTERSTITIAL LUNG DISEASE, PULMONARY FIBROSIS and RESTRICTIVE PULMONARY DISEASE. At the time of the report, PULMONARY FIBROSIS (pulmonary fibrosis), INTERSTITIAL LUNG DISEASE (interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere), BRONCHIECTASIS (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced), ACUTE RESPIRATORY FAILURE (acute respiratory failure with hypoxia/dyspnea on exertion), INFLAMMATION (possibility of an acute inflammatory response to her COVID-19 vaccination), RESTRICTIVE PULMONARY DISEASE (restrictive lung disease) and CONDITION AGGRAVATED (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced) had not resolved and MUSCLE SPASMS (diffuse cramping/leg cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Computerised tomogram: no sign change (Inconclusive) stable findings of pulmonary fibrosis/chronic interstitial lung disease. On 27-Jan-2021, Oxygen saturation: 99 % (normal) 99 room air. On 27-Jan-2021, Pulmonary function test: abnormal (abnormal) moderate reduction in diffusion capacity; forced vital, total lung, and diffusion capacities diminished. On 03-Mar-2021, Oxygen saturation: 95 % (normal) room air. On 04-Mar-2021, Computerised tomogram: abnormal (abnormal) no PE, dramatic worsening of diffuse infiltrates much c/w UIP pattern; bronchiectasis in lower lobes more pronounced. On 05-Mar-2021, Oxygen saturation: 80 % (abnormal) 94 at rest, 80 when ambulating, then 96 when ambulating with O2. On 08-Mar-2021, Echocardiogram: abnormal (abnormal) EF 60-65%, RVSP moderately elevated- 45 mmHg, mild MV regurgitation. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) low lung volumes with reticular opacities both lungs-uncertain if acute pneumonia or chronic fibrotic chnage. On 22-Mar-2021, Computerised tomogram: abnormal (abnormal) increased small pleural effusion and evidence of ischemic cardiomyopathy; overall fibrosis increased. On 23-Mar-2021, Bronchoscopy: abnormal (abnormal) neutrophilic lavage with negative cultures. On 09-Apr-2021, Oxygen saturation: 78 % (Low) 78% Room air 88% on 4L/min O2; 91% on 8L/min. On 14-Apr-2021, Chest X-ray: abnormal (abnormal) diffuse interstitial infiltrates, no pleural effusion.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLAMMATION (possibility of an acute inflammatory response to her COVID-19 vaccination) to be possibly related. No further causality assessments were provided for PULMONARY FIBROSIS (pulmonary fibrosis), INTERSTITIAL LUNG DISEASE (interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere), BRONCHIECTASIS (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced), ACUTE RESPIRATORY FAILURE (acute respiratory failure with hypoxia/dyspnea on exertion), RESTRICTIVE PULMONARY DISEASE (restrictive lung disease), CONDITION AGGRAVATED (CT scan 04 Mar 2021 showed bronchiectasis in lower lobes more pronounced) and MUSCLE SPASMS (diffuse cramping/leg cramps).    Patient was seen by physician (MD) (the reporter, a pulmonary specialist) on 27 Jan 2021 with complaint of short of breath with heavy exertion; was chronically breathless going up stairs.  Her pulmonary physiology had been relatively stable over last couple of years.  Impression: Appeared to have worsening restrictive physiology (also reported as slight worsening) in the setting of stable pulmonary fibrosis on imaging.  Then, on 04 Mar 2021, the patient presented with worsened breathlessness of rather acute onset, starting approximately 24 Feb 2021.  Repeat CT scan showed no pulmonary embolism but showed dramatic worsening of her pulmonary parenchyma and then findings suggesting exacerbation of underlying IPF like picture.  The was also a significant change in spirometry.  She was placed on large dose prednisone with transient stabilization but then presented to the emergency room on 21 Mar 2021 very breathless.  No obvious infectious like picture.  She was treated with high-dose corticosteroids.  One more CT scan showed continued abnormalities with again increased ground-glass opacification.  She showed desaturation with limited activity.  The patient was hospitalized for 7 days, then discharged to inpatient rehab for 10 days on prednisone 60 mg.  She improved slightly and was discharged home on 6L of O2 with exertion and 4L at rest.  On 14 Apr 2021, the patient saw MD for follow-up at which time she was breathless with any significant activities and had difficulty getting around.  She was approved for nintedanib therapy for progressive pulmonary fibrosis.  Assessment included acute on chronic respiratory failure with hypoxia.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.