Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Bronchiolitis obliterans following a relatively mild COVID-19 infection; chronic interstitial pneumonitis; methicillin-susceptible staphylococcus aureus; COVID-19 infection, despite full vaccination with the Moderna vaccine; COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of OBLITERATIVE BRONCHIOLITIS (Bronchiolitis obliterans following a relatively mild COVID-19 infection) and INTERSTITIAL LUNG DISEASE (chronic interstitial pneumonitis) in a 49-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: The patient's past medical history included Seasonal allergy and Childhood asthma. Concurrent medical conditions included Ex-smoker, Hyperlipidemia and Bipolar disorder. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced OBLITERATIVE BRONCHIOLITIS (Bronchiolitis obliterans following a relatively mild COVID-19 infection) (seriousness criterion medically significant), INTERSTITIAL LUNG DISEASE (chronic interstitial pneumonitis) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (methicillin-susceptible staphylococcus aureus), VACCINATION FAILURE (COVID-19 infection, despite full vaccination with the Moderna vaccine) and COVID-19 (COVID-19 infection). The patient was treated with Prednisone at an unspecified dose and frequency; Mycophenolate mofetil at an unspecified dose and frequency; Azithromycin at a dose of UNK, qd; Rehabilitation therapy (pulmonary rehabilitation) for Obliterative bronchiolitis and Rehabilitation therapy (pulmonary rehabilitation) for Interstitial lung disease. At the time of the report, OBLITERATIVE BRONCHIOLITIS (Bronchiolitis obliterans following a relatively mild COVID-19 infection), INTERSTITIAL LUNG DISEASE (chronic interstitial pneumonitis), STAPHYLOCOCCAL INFECTION (methicillin-susceptible staphylococcus aureus), VACCINATION FAILURE (COVID-19 infection, despite full vaccination with the Moderna vaccine) and COVID-19 (COVID-19 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-cyclic citrullinated peptide antibody: (Negative) CCP. On an unknown date, Antineutrophil cytoplasmic antibody: Negative. On an unknown date, Antinuclear antibody: Negative, (Negative) Jo-1, (Negative) RNP, (Negative) Scl-70, (Negative) Sm, (Negative) SSA and (Negative) SSB. On an unknown date, Biopsy lung: A surgical lung biopsy was pursued and revealed a dominant pattern of inflammatory and obliterative small airway disease with an associated patchy chronic interstitial pneumonitis. There were no granulomas, organizing pneumonia, peribronchiolar metaplasia, vasculitis, capillaritis or parenchymal fibrosis. On an unknown date, Blood test: no peripheral eosinophilia. On an unknown date, Bronchoscopy: was unremarkable with mild bronchitic changes, macrophage predominant differential. On an unknown date, C-reactive protein: Negative. On an unknown date, CFTR gene mutation: Negative. On an unknown date, Culture: (Positive) few methicillin-susceptible staphylococcus aureus. On an unknown date, HIV test: Negative. On an unknown date, Hepatitis C antibody: (Negative) HCV antibody. On an unknown date, High-resolution computerised tomogram of lung: High-resolution computed tomography scan demonstrated irregular pulmonary nodules, multifocal ground glass opacities, diffuse bronchiectasis and no air trapping. On an unknown date, Immunoglobulins: normal. On an unknown date, Investigation: (Negative) hypersensitivity pneumonitis screen. On an unknown date, Pulmonary function test: revealed severe, fixed obstruction with a forced expiratory volume in one second (FEV1) of 47% predicted and a normal diffusing capacity and Repeat PFTs were notable for worsening fixed obstruction with an FEV1 down to 28% predicted. On an unknown date, Red blood cell sedimentation rate: Negative. On an unknown date, Rheumatoid factor: Negative. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Active man presented with progressive exertional dyspnea and fatigue 6 weeks following non-serious COVID-19 infection, despite full vaccination with the Moderna vaccine. The patient was started on an inhaled corticosteroid and a short acting bronchodilator, but continued to have progressive dyspnea, wheezing, and a cough productive of yellow sputum. Cultures were positive for few methicillin-susceptible staphylococcus aureus that were treated without improvement. In total, the largely airway-centric findings were compatible with bronchiolitis obliterans following a relatively mild COVID-19 infection. Prednisone and mycophenolate mofetil were started without benefit. Daily azithromycin and pulmonary rehabilitation helped stabilize the patient's symptoms and PFTs. He was referred to a lung transplant center for further monitoring. Patient had no history of transplantation, toxin exposure, other infections or autoimmune disease were identified. A multidisciplinary approach integrating pulmonology, radiology, thoracic surgery, and pathology was essential to optimize patient management and preserve functionality and quality of life. Author concluded that post-infectious BO was an uncommon and under-diagnosed condition that requires a high index of suspicion and required a collaborative approach to diagnosis and treatment. This case represents the only reported instance of biopsy proven post-COVID-19 BO in an adult.; Reporter's Comments: Company comment: Medical history of smoking and recent COVID 19 infection and presence of additional infectious agents confounds causality assessment for bronchiolitis obliterans and interstitial lung disease. Causality for staphylococcal infection is assessed as not related considering infectious nature of events and lack of biological plausibility for causality. The benefit-risk relationship of product is not affected by this report.
Bipolar disorder; Ex-smoker; Hyperlipidemia
Medical History/Concurrent Conditions: Childhood asthma; Seasonal allergy
Test Name: CCP; Test Result: Negative ; Test Name: ANCA; Test Result: Negative ; Test Name: ANA; Test Result: Negative ; Test Name: Jo-1; Test Result: Negative ; Test Name: RNP; Test Result: Negative ; Test Name: Scl-70; Test Result: Negative ; Test Name: Sm; Test Result: Negative ; Test Name: SSA; Test Result: Negative ; Test Name: SSB; Test Result: Negative ; Test Name: lung biopsy; Result Unstructured Data: A surgical lung biopsy was pursued and revealed a dominant pattern of inflammatory and obliterative small airway disease with an associated patchy chronic interstitial pneumonitis. There were no granulomas, organizing pneumonia, peribronchiolar metaplasia, vasculitis, capillaritis or parenchymal fibrosis; Test Name: Blood work; Result Unstructured Data: no peripheral eosinophilia; Test Name: Bronchoscopy; Result Unstructured Data: was unremarkable with mild bronchitic changes, macrophage predominant differential; Test Name: Cystic fibrosis mutations; Test Result: Negative ; Test Name: CRP; Test Result: Negative ; Test Name: cultures; Test Result: Positive ; Test Name: HCV antibody; Test Result: Negative ; Test Name: High-resolution computed tomography scan; Result Unstructured Data: High-resolution computed tomography scan demonstrated irregular pulmonary nodules, multifocal ground glass opacities, diffuse bronchiectasis and no air trapping; Test Name: HIV tests; Test Result: Negative ; Test Name: Immunoglobulins; Result Unstructured Data: normal; Test Name: hypersensitivity pneumonitis screen; Test Result: Negative ; Test Name: Pulmonary function testing (PFT); Result Unstructured Data: revealed severe, fixed obstruction with a forced expiratory volume in one second (FEV1) of 47% predicted and a normal diffusing capacity; Test Name: Pulmonary function testing (PFT); Result Unstructured Data: Repeat PFTs were notable for worsening fixed obstruction with an FEV1 down to 28% predicted; Test Name: ESR; Test Result: Negative ; Test Name: RF; Test Result: Negative