Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Blood bicarbonate, Blood culture, Blood gases, Blood lactate dehydrogenase
Clinical narrative: he was diagnosed with AE-IPF; This is a literature report.  A 72 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "IPF" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Nintedanib for IPF. The following information was reported: IDIOPATHIC PULMONARY FIBROSIS (medically significant), outcome "recovered", described as "he was diagnosed with AE-IPF". Therapeutic measures were taken as a result of idiopathic pulmonary fibrosis.  A 72-year-old gentleman with a medical history significant for IPF of 8 years duration that had been treated with nintedanib presented with progressive dyspnea over 1 week. Two weeks earlier ,he had received his first dose of the BNT162b2 mRNA COVID-19 vaccine. One week after vaccination, he experienced worsening dyspnea, an increasing, nonproductive cough, fevers, and chills. He denied any sick contacts or recent travel. He was fully adherent to masking and social distancing. He denied any chest pains, palpitations, or lower extremity edema. He denied any episodes of  difficulty swallowing ,aspiration, or gastroesophageal reflux symptoms. He had not undergone any recent surgeries, blood transfusions ,or medication changes. Three days before presentation he had a negative COVID-19 nasopharyngeal swab. On presentation, he was in acute hypoxemic respiratory failure(arterial bloodgas,7.49;PCO2, 32mmHg;PAO2, 68mmHg; HCO3, 24mEq/L) requiring 4 liters of oxygen. His laboratory data were significant for an elevated lactic acid ,lactate dehydrogenase, erythrocyte sedimentation rate,C-reactive protein ,and D-dimer; his troponin and brain natriuretic peptide levels were normal His chest radiograph revealed worsening pulmonary infiltrates. Despite his recent vaccination and negative test, he was placed on air borne isolation and a nasopharyngeal swab forCOVID-19; a complete respiratory viral panel was performed. These tests, including two repeated COVID-19 swabs, were negative. CT angiography was negative for pulmonary embolism but showed new findings of diffuse ground-glass opacities. Broad-spectrum antibiotics were discontinued once his blood, sputum, and urine cultures results were negative. An echocardiogram revealed normal cardiac function. Because no cause for his respiratory deterioration was identified, he was diagnosed with AE-IPF, possibly related to his recent vaccination. He received methylprednisolone 125mg IV then transitioned to a 3- week prednisone taper. After steroid treatment, supplemental oxygen was weaned; the lactic acid, lactate dehydrogenase, erythrocyte sedimentation rate, C-reactive protein, and D-dimer levels normalized, and he was discharged home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event IDIOPATHIC PULMONARY FIBROSIS and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.