Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Mean cell volume, Pathology test, Platelet count, Prothrombin time
Clinical narrative: A swab COVID test resulted positive; A swab COVID test resulted positive; This is a literature report for the following literature source(s).  A 66-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Jan2022 as dose 1, single (Batch/Lot number: unknown) and in Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "systemic arterial hypertension" (unspecified if ongoing); "osteoporosis", start date: 2007 (unspecified if ongoing); "dry eye", start date: 2019 (unspecified if ongoing). The patient's medical history, reported also as family history included: "mother with epilepsy" (unspecified if ongoing), notes: mother; "father who died from hepatic cirrhosis" (unspecified if ongoing), notes: father; "daughter who died because of chronic kidney disease" (unspecified if ongoing), notes: daughter. The patient's concomitant medications were not reported. Past drug history included: Angiotensin 2 receptor antagonists for systemic arterial hypertension; Bisphosphonate for osteoporosis; Lubricant eye drop for dry eye. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "A swab COVID test resulted positive". The patient underwent the following laboratory tests and procedures: Activated partial thromboplastin time (11-13.5): (unspecified date) 30 seconds, notes: (normal: 11-13.5s, 0.8-1.1, 25-35s, respectively); Antibody test: (unspecified date) positive; Antineutrophil cytoplasmic antibody: (unspecified date) 124.6 IU/ml; Biopsy kidney: (unspecified date) ischemic type sclerosant glomeruli,, notes: mesangial expansion, segmentary necrotizing lesions with fibrin: compatible with focal and segmentary glomerulonephritis; Blood creatinine (0.7-1.1): (unspecified date) 3.81 mg/dl; (unspecified date) 3.91 mg/dl, notes: basal Cr: 0.9mg/DL; Blood potassium (normal high range 5.5): (unspecified date) 6.6 meq/dL; Blood test: (unspecified date) revealed a moderate normocytic,, notes: normochromic anemia; Blood urea: (unspecified date) 78 mg/dl; Bronchoscopy: (unspecified date) which confirmed the, notes: diagnosis of DAH after bronchoalveolar lavage; Computerised tomogram: (unspecified date) revealed bilateral diffuse alveolar, notes: opacities, a finding consistent with diffuse alveolar hemorrhage (DAH); Haematocrit (normal high range 30): (unspecified date) 19 %; Haemoglobin (normal high range 12.5): (unspecified date) 6.6 g/dl; Immunology test: (unspecified date) Negative, notes: for Immunoglobulins G, A, M, Cq1, C3c, C4c, and fibrinogen; (unspecified date) unknown result; (unspecified date) demonstrated pauci-immune, notes: deposition of immune complexes; International normalised ratio: (unspecified date) 1; Mean cell volume (80-100): (unspecified date) 93.9, notes: fl; Pathology test: (unspecified date) reported active and fibrous, notes: extracapillary proliferative glomerulonephritis, diffuse pauciimmune type, with fibrinoid necrosis and segmental sclerosis, active tubulo- interstitial nephritis, active multifocal tubular injury, interstitial fibrosis grade II (40%), and moderate arteriosclerosis; Platelet count (100000-450000): (unspecified date) 347000, notes: Unit:/dl; Prothrombin time: (unspecified date) 12 seconds; SARS-CoV-2 test: (19Jul2022) positive; Serology test: (unspecified date) 1:100, notes: p-ANCA; Urine analysis: (unspecified date) revealed dysmorphic red blood cells; White blood cell count (4-11.5): (unspecified date) 12.1, notes: Unit: K/dl.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. 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.,Linked Report(s) : US-PFIZER INC-202300261909 Same article/drug/patient and different event;