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This is VAERS ID 1416322

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First Appeared on 7/9/2021

VAERS ID: 1416322
VAERS Form:2
Age:
Sex:Female
Location:Foreign
Vaccinated:2021-05-03
Onset:2021-05-06
Submitted:0000-00-00
Entered:2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other      Purchased by: ??
Symptoms: Blood fibrinogen, Cerebral haemorrhage, Fibrin D dimer, International normalised ratio, Platelet count, Platelet factor 4

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:0000-00-00
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Coagulation disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: Fibrinogen; Result Unstructured Data: Test Result:3.75 g/dl; Test Date: 20210506; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:639 ng/dL; Test Date: 20210506; Test Name: International normalised ratio; Result Unstructured Data: Test Result:2.46; Comments: 2.46 to 6/5; Test Date: 20210506; Test Name: Platelet count; Result Unstructured Data: Test Result:200000 /mm3; Test Date: 20210506; Test Name: Platelet factor 4; Test Result: Positive ; Comments: Positive anti-FP4 antibodies (ELISA)
CDC 'Split Type': PTPFIZER INC2021699027

Write-up: Massive intraparenchymal hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [PT-INFARMED-J202105-2472]. A 75-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 0.3ml single dose for COVID-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, hypocoagulation. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient experienced massive intraparenchymal hemorrhage (death, medically significant) on 06May2021. The clinical course was reported as follows: Spontaneous notification refers to a case sent by a doctor for a 75-year-old female who presented massive intraparenchymal hemorrhage, associated with the use of Comirnaty (unknown batch), indicated for immunization against COVID-19, with a scheme of 2 doses vaccination with an interval of at least 21 days between each dose. The adverse drug reaction (ADR) appeared 3 days after administration of the suspected vaccine (which dose is unknown) and had a fatal outcome. A history of ADR to other drugs is unknown. Patient with hypocoagulation due to atrial fibrillation. Analytical results on the day of ADR (06May2021): INR 2.46; D-Dimers 639 ng/ml; Fibrinogen 3.75 g/dL; 200000/mm3 platelets; Anti-FP4 antibodies (by ELISA method) Positive. There is reference to the concomitant use of Warfarin. There was no medication error. The hospital institution of the notifier''s origin refers to this adverse condition as: "Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT)". Evolution of ADR: Death. In subsequent telephone contact, the notifier states that, as no thrombocytopenia occurred, the case does not configure the entity Vaccine-induced Immune Thrombotic Thrombocytopenia. Evolution of ADR: Death. INR 2.46 to 6/5, D-Dimers 639 ng/ml, Fibrinogen 3.75 g/dl, Positive anti-FP4 antibodies (ELISA), Platelets: 200,000/mm3 The patient underwent lab tests and procedures which included blood fibrinogen: 3.75 g/dl on 06May2021, fibrin d dimer: 639 ng/dl on 06May2021, international normalised ratio: 2.46 on 06May2021 (2.46 to 6/5), platelet count: 200000 /mm3 on 06May2021, platelet factor 4: positive on 06May2021 (Positive anti-FP4 antibodies (ELISA)). The patient died in 2021. It was not reported if an autopsy was performed. The outcome of event was fatal. Relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: definitive Reporter Comment: Concomitant Medication-Warfarin Did Medication Error Occur?-No Other Information-Hypocoagulated by AF, INR 2.46 to 6/5. Other analyses: D-Dimers 639 ng/ml, Fibrinogen 3.75 g/dl, Positive anti-FP4 antibodies (ELISA), Platelets: 200,000/mm3 No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reporter''s Comments: Concomitant Medication-Warfarin Did Medication Error Occur?-No Other Information-Hypocoagulated by AF, INR 2.46 to 6/5. Other analyses: D-Dimers 639 ng/ml, Fibrinogen 3.75 g/dl, Positive anti-FP4 antibodies (ELISA), Platelets: 200000/mm3; Reported Cause(s) of Death: Hemorrhage intracerebral

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