Adverse Event Reporting
| VAERS ID | 2567134 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | |
| Onset | |
| Condition | Hospitalized Life Threatening Died |
Symptoms
- Blood test
- Computerised tomogram
- Blood lactate dehydrogenase
- Coagulation test
- Thrombotic thrombocytopenic purpura
- Antinuclear antibody
- Investigation
- Platelet count
- Haemoglobin
- Blood bilirubin
- Immunology test
- Autoantibody test
- Reticulocyte count
- ADAMTS13 activity assay
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Plasmapheresis (Daily)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Name: ADAMTS-13 activity; Result Unstructured Data: Test Result:0.
06 IU/ml; Comments: aTTP was confirmed; Test Name: antinuclear antibody; Result Unstructured Data: Test Result:greater than 640 titer; Test Name: autoantibodies to ADAMTS-13; Result Unstructured Data: Test Result:greater than 92 IU/ml; Test Name: bilirubin; Result Unstructured Data: Test Result:normalization; Comments: day 6; Test Name: lactate dehydrogenase; Result Unstructured Data: Test Result:normalization; Comments: day 6; Test Name: peripheral blood; Result Unstructured Data: Test Result:schistocytes with hemolysis; Test Name: coagulation profile; Result Unstructured Data: Test Result:normal; Test Name: computed tomography scan; Result Unstructured Data: Test Result:showed no evidence of malignancy,; Comments: but features of pulmonary hypertension; Test Name: hemoglobin; Result Unstructured Data: Test Result:67 g/l; Test Name: negative anti-platelet factor 4 assay; Result Unstructured Data: Test Result:excluded vaccine-induced immune thrombotic; Comments: thrombocytoopenia; Test Name: antibodies against ADAMTS-13 and Spike S1 antigen of SARS-CoV-2; Result Unstructured Data: Test Result:0.
026; Comments: Patient 1 pretreatment Dilution: 1:50; Test Name: antibodies against ADAMTS-13 and Spike S1 antigen of SARS-CoV-2; Result Unstructured Data: Test Result:0.
028; Comments: Patient 1 pretreatment Dilution: 1:100; Test Name: antibodies against ADAMTS-13 and Spike S1 antigen of SARS-CoV-2; Result Unstructured Data: Test Result:0.
024; Comments: Patient 1 pretreatment Dilution: 1:50; Test Name: antibodies against ADAMTS-13 and Spike S1 antigen of SARS-CoV-2; Result Unstructured Data: Test Result:0.
021; Comments: Patient 1 pretreatment Dilution: 1:100; Test Name: IgG cobinding to both COVID Spike S1 and ADAMTS-13 proteins; Result Unstructured Data: Test Result:0.
023; Comments: Patient 1 pretreatment; Test Name: IgG cobinding to both COVID Spike S1 and ADAMTS-13 proteins; Result Unstructured Data: Test Result:0.
024; Comments: Patient 1 pretreatment; Test Name: PLASMIC score; Result Unstructured Data: Test Result:7; Comments: indicating high risk of severe ADAMTS-13 deficiency; Test Name: platelet; Result Unstructured Data: Test Result:9 x10 9/l; Test Name: platelet; Result Unstructured Data: Test Result:115 x10 9/l; Test Name: platelet; Result Unstructured Data: Test Result:11 x10 9/l; Comments: dropped acutely L with recurrence of hemolysis; Test Name: reticulocyte count; Test Result: 4 %
Write-up
acquired Thrombotic Thrombocytopenic purpura; This is a literature report.
A 39-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.
The patient's relevant medical history included: "plasmapheresis" (unspecified if ongoing), notes: Daily.
The patient's concomitant medications were not reported.
The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (death, hospitalization, medically significant, life threatening), 28 days after the suspect product(s) administration, outcome "fatal", described as "acquired Thrombotic Thrombocytopenic purpura".
The patient underwent the following laboratory tests and procedures: ADAMTS13 activity assay (normal low range 0.
65): 0.
06 IU/ml, notes: aTTP was confirmed; Antinuclear antibody (normal high range 80): greater than 640 titer; Autoantibody test (normal high range 15): greater than 92; Blood bilirubin: normalization, notes: day 6; Blood lactate dehydrogenase: normalization, notes: day 6; Blood test: schistocytes with hemolysis; Coagulation test: normal; Computerised tomogram: showed no evidence of malignancy,, notes: but features of pulmonary hypertension; Haemoglobin: 67 g/l; Immunology test: excluded vaccine-induced immune thrombotic, notes: thrombocytopenia; antibodies against ADAMTS-13 and Spike S1 antigen of SARS-CoV-2: 0.
026, notes: Patient 1 pretreatment, Dilution: 1:50; 0.
028, notes: Patient 1 pretreatment, Dilution: 1:100; 0.
024, notes: Patient 1 pretreatment, Dilution: 1:50; 0.
021, notes: Patient 1 pretreatment, Dilution: 1:100; 0.
023, notes: Patient 1 pretreatment; 0.
024, notes: Patient 1 pretreatment; 7, notes: indicating high risk of severe ADAMTS-13 deficiency; Platelet count: 9 x10 9/l; 115 x10 9/l; 11 x10 9/l, notes: dropped acutely L with recurrence of hemolysis; Reticulocyte count (0.
5-2.
3): 4 %.
Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura.
The patient date of death was unknown.
Reported cause of death: "acquired Thrombotic Thrombocytopenic purpura", "deceased on day 8 after admission".
It was not reported if an autopsy was performed.
Clinical course: A 39 years old female presented with symptomatic anemia and fever, 28 days after receiving the first dose of BNT162b2 (Pfizer/BioNTech) mRNA COVID-19 vaccine.
Her hemoglobin (Hb) was 67 g/L, platelet 9 x 10^9/L, and reticulocyte count 4% (0.
52.
3%).
There were schistocytes in the peripheral blood film with hemolysis, while her coagulation profiles were normal.
A negative anti-platelet factor 4 (PF4), assay by ELISA excluded vaccine-induced immune thrombotic thrombocytopenia (VITT).
Her PLASMIC score was 7, indicating high risk of severe ADAMTS-13 deficiency.
aTTP was confirmed with ADAMTS-13 activity 0.
06 IU/mL (greater than or equal to 0.
65) and autoantibodies to ADAMTS-13>92 U/mL (less than 15).
A whole-body computed tomography scan showed no evidence of malignancy, but features of pulmonary hypertension.
Her antinuclear antibody (ANA) was > 640 titer (normal<80).
She responded well initially to prednisolone and daily plasmapheresis; aspirin was commenced on day 5 at a platelet count of 1150x10^9/L with normalization of bilirubin and lactate dehydrogenase (LDH) by day 6.
However, on day 7, her platelet count dropped acutely to 11x10^9/L with recurrence of hemolysis.
Rituximab was administered.
She subsequently developed chest discomfort with type 1 respiratory failure.
Acute myocardial infarction, pulmonary embolism, pulmonary hemorrhage, and infections were ruled out but she unfortunately deceased on day 8 after admission.
; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event acquired Thrombotic Thrombocytopenic purpura and the use of suspect product BNT162b2 cannot be fully excluded.
The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.
,Linked Report(s) : SG-PFIZER INC-202300031388 Same Article/drug and different patient/event;; Reported Cause(s) of Death: acquired Thrombotic Thrombocytopenic purpura; deceased on day 8 after admission