Sex: F
Vaccine: COVID19
Symptoms: Protein total normal, Prothrombin time, Red blood cell count, Serology test, Vital signs measurement
Clinical narrative: This is a literature report for the following literature source entitled: "BNT162b2 COVID-19 Vaccine Induced Immune Thrombocytopenic Purpura", Case Reports in Medicine, 2022; This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. This is a literature report for the following literature source(s): "BNT162b2 COVID-19 Vaccine Induced Immune Thrombocytopenic Purpura". A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "mild dyspnea" (unspecified if ongoing), notes: after receiving her first COVID-19 vaccine 3 weeks earlier. Dyspnea was not associated with chest pain or leg edema; "COPD" (unspecified if ongoing); "type 2 diabetes mellitus" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "mild bruising of her tongue" (unspecified if ongoing), notes: but no active bleeding; "rash" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Antihypertensive; Citalopram. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), outcome "recovered", described as "Immune Thrombocytopenic Purpura". The patient was hospitalized for immune thrombocytopenia (start date: 26Sep2021). The event "immune thrombocytopenic purpura" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (5-30): (26Sep2021) 44 IU/l; Angiogram: (unspecified date) negative, notes: for pulmonary embolism; Antibody test: (unspecified date) negative; (unspecified date) negative; (unspecified date) negative; (unspecified date) negative; Antinuclear antibody: (unspecified date) negative; (unspecified date) negative; Aspartate aminotransferase (5-30): (26Sep2021) 33 IU/l; Blood albumin (3.5-5.4): (26Sep2021) 2.7 g/dl; Blood alkaline phosphatase (44-147): (26Sep2021) 39 IU/l; Blood bilirubin (0.3-1.9): (26Sep2021) 0.5 mg/dl; Blood creatinine (0.6-1.2): (26Sep2021) 1.04 mg/dl; Blood folate (2-20): (26Sep2021) 18.1 ng/ml; Blood iron (30-170): (26Sep2021) 75 ug/dL; Blood lactate dehydrogenase (50-150): (unspecified date) normal; (26Sep2021) 131 IU/l; Blood smear test: (unspecified date) was normal except for decreased platelets without, notes: evidence of immature platelets; Blood test: (unspecified date) Subsequent workup including absence of, notes: schistocytes on peripheral smear; Blood urea (6-20): (26Sep2021) 33 mg/dl; Computerised tomogram head: (unspecified date) showed no intracranial bleeding; Culture: (unspecified date) positive for Sjogren's Ab (SS-A); (unspecified date) Positive for scleroderma antibodies; (unspecified date) Workup for other causes of thrombocytopenia, notes: including hepatitis serology, HIV, EBV, ANA, Smith Ab, RNP ab, anti-Jo1 Ab, anti-dsDNA Ab, anti-centromere, and Sjogren's ab (SS-B) was negative; Double stranded DNA antibody: (unspecified date) negative; Epstein-Barr virus antibody: (unspecified date) negative; Fibrin D dimer (normal low range 0.5): (26Sep2021) 0.850 ug/ml; Haematocrit (36.1-44.3): (26Sep2021) 37.9 %; Haemoglobin (12.1-15.1): (26Sep2021) 12.7 g/dl; Haptoglobin (41-165): (26Sep2021) 177 mg/dl; HIV test: (unspecified date) negative; International normalised ratio (0.9-1.2): (26Sep2021) 1.04, notes: Unit not reported; PTT (20-40): (26Sep2021) 25.4 seconds; Laboratory evaluation: (unspecified date) showed normocytic anemia, notes: normal white blood cell count, and platelet count was 0/uL; Physical examination: (unspecified date) revealed generalized petechiae and subcutaneous, notes: bruises on the lower back; Platelet count (150-450): (26Sep2021) 0 x10 3/mm3, notes: on day 1; (28Sep2021) 1 x10 3/mm3, notes: on day 3; (30Sep2021) 5 x10 3/mm3, notes: on day 5; (01Oct2021) 15 x10 3/mm3, notes: on day 6; (02Oct2021) 11 x10 3/mm3, notes: on day 7; (03Oct2021) 8 x10 3/mm3, notes: on day 8; (05Oct2021) 14 x10 3/mm3; (09Oct2021) 99 x10 3/mm3, notes: on day 14; (19Oct2021) 372 x10 3/mm3; (27Oct2021) 201 x10 3/mm3, notes: day 33; Protein total normal (6-8.3): (26Sep2021) 8.3 g/dl; Prothrombin time (11-14): (26Sep2021) 11.9 seconds; Red blood cell count (4.2-5.4): (26Sep2021) 3.01 x10 9/l, notes: normocytic anemia; Serology test: (unspecified date) negative; Vital signs measurement: (unspecified date) remained stable, notes: and overall health; Vitamin B12 (130-700): (26Sep2021) 1469 pg/mL; White blood cell count (4.5-10): (unspecified date) normal; (26Sep2021) 6.8 x10 3/mm3. Therapeutic measures were taken as a result of immune thrombocytopenia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information available, a possible contributory role of the suspect cannot be excluded for the reported events of Immune Thrombocytopenic Purpura. 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.