Sex: M
Vaccine: COVID19
Symptoms: Heart rate, International normalised ratio, Investigation, Laboratory test, Necrotising fasciitis
Clinical narrative: consistent with prior history of PF; diffuse necrotic cutaneous tissue sequelae; dry gangrene of upper extremity; necrotizing fasciitis; cellulitis; vasculitis; Drug ineffective; COVID-19; This is a literature report.   A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Purpura fulminans" (unspecified if ongoing); "admitted to experiencing flu-like symptoms" (unspecified if ongoing), notes: Flu-like symptoms; "flu-like symptoms" (unspecified if ongoing), notes: Flu-like symptoms. The patient's concomitant medications were not reported. The following information was reported: PURPURA FULMINANS (hospitalization, medically significant, life threatening), outcome "unknown", described as "consistent with prior history of PF"; SKIN NECROSIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "diffuse necrotic cutaneous tissue sequelae"; DRY GANGRENE (hospitalization, medically significant, life threatening), outcome "unknown", described as "dry gangrene of upper extremity"; NECROTISING FASCIITIS (hospitalization, medically significant), outcome "unknown", described as "necrotizing fasciitis"; CELLULITIS (hospitalization, medically significant), outcome "unknown"; VASCULITIS (hospitalization, medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The events "necrotizing fasciitis", "cellulitis" and "vasculitis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: less than 1:20, notes: negative (neg 1 < 1:20) (On the third day of admission); Antineutrophil cytoplasmic antibody (0.0-9.0): less than 9, notes: Negative (On the third day of admission); less than 1:20, notes: negative (neg 1 < 1:20) (On the third day of admission); Antineutrophil cytoplasmic antibody (0-3.5): less than 3.5, notes: Negative (On the third day of admission); Antinuclear antibody: less than 1:80, notes: Negative (neg < 1:80) (On the third day of admission); Blood creatinine (0.74-1.35): 2.19 mg/dl; 1.14 mg/dl, notes: On the third day of admission; Blood culture: showed no growth.; Blood fibrinogen (175-400): 50 mg/dl, notes: On sixth day of admission; 249 mg/dl, notes: On the third day of admission; Blood lactic acid (0.5-2.2): 2.43 mmol/L, notes: elevated; Blood pressure measurement: 104/57 mmHg; Blood urea: 45 mg/dl, notes: nl: 2.1-8.5 mmol/l; 21 mg/dl, notes: trended down (On the third day of admission); Chest X-ray: showed no obvious focal lung opacities, effusions, notes: or pneumothorax; Fibrin D dimer (normal high range 0.5): 35.20, notes: severely elevated (On sixth day of admission); Heart rate: 96, notes: beats/minute; HIV antibody: non-reactive, Negative, notes: On the third day of admission; non-reactive, Negative, notes: On the third day of admission; International normalised ratio (0.8-1.20): 1.40, notes: On sixth day of admission; Review of systems on admission: unremarkable; laboratory: showed decreased levels of Protein S activity 26, notes: (nl: 63-140%) with normal Protein S levels of total and free 67 (nl: 61-136%) and normal protein C function 93 (nl: 73-180%) consistent with prior history of PF. (On the third day of admission); revealed elevated lactic acid of 2.43 mmol/l, notes: (nl: 0.5-2.2 mmol/l), white blood cell count of 15.66 X 109/l (nl: 4.5-11 X 109/l), blood urea nitrogen of 45 mg/dl (nl: 2.1-8.5 mmol/l) and creatinine of 2.19 mg/dl (nl: 0.74-1.35 mg/dl). Troponin I 78 (nl: 0-22 ng/l), and slightly elevated prothrombin time of 12.5 (nl: 9.3-12.4 s); Pain assessment: rated at 8/10; physical exam: exhibited non-labored respirations without, notes: accessory muscle use or audible wheezes. No icterus or injected conjunctiva were observed; the oropharynx was moist without exudates. Extremities were warm and well perfused. There were 2+ radial pulses bilaterally with a full range of motion; 2+ pitting edema was present at the right lower extremity. The skin was warm and dry. Large areas of palpable purpura with surrounding erythema and induration were observed at bilateral buttocks; PO2: 97 %; Protein C (73-180): 93 %, notes: normal (On the third day of admission); Protein S (63-140): 26 %, notes: decreased levels (On the third day of admission); Protein S (61-136): 67 %, notes: normal (On the third day of admission); Protein S: normal, notes: On the third day of admission; Prothrombin time (9.3-12.4): 12.5 seconds, notes: slightly elevated; 14.4 seconds, notes: worsening (On sixth day of admission); Respiratory rate: 25, notes: breaths/minute; SARS-CoV-2 test: positive for COVID-19 infection; Troponin I (0-22): 78 ng/L; Ultrasound Doppler: showed no arterial thrombus, notes: On sixth day of admission; showed no evidence of deep venous thrombosis., notes: There was no superficial thrombophlebitis; White blood cell count (4.5-11): 15.66 x10 9/l; 16.69 x10 9/l, notes: continued to have an upward trending (On the third day of admission). Therapeutic measures were taken as a result of purpura fulminans, skin necrosis, dry gangrene.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.