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This is VAERS ID 1419452

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First Appeared on 6/25/2021

VAERS ID: 1419452
VAERS Form:2
Age:84.0
Sex:Female
Location:Foreign
Vaccinated:2021-06-04
Onset:2021-06-10
Submitted:0000-00-00
Entered:2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 LA / OT

Administered by: Other      Purchased by: ??
Symptoms: Altered state of consciousness, Disseminated intravascular coagulation, Pyrexia, Sepsis, Viral test, Escherichia test

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2021-06-13
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Escherichia test; Test Result: Positive ; Test Date: 20210610; Test Name: SFTS reaction; Test Result: Positive
CDC 'Split Type': JPPFIZER INC2021710905

Write-up: pyrexia; Disseminated intravascular coagulation; Sepsis; Consciousness disturbed; This is a spontaneous report from the contactable physician. An 84-year-old female patient received second dose of BNT162B2 (COMIRNATY) Lot number EX3617, expiration date 31Aug2021, Intramuscular in left arm on 04Jun2021 11:30 at single dose (at the age of 84-year-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient has been tested for COVID-19 after the vaccination. Medical history included hypertension and chronic hepatitis C (post therapy). Concomitant medications included antihypertensive drug, proton-pump inhibitor (PPI), vitamin D preparation and coronary dilator. On 14May2021 at 13:15, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) intramuscular in the left arm for COVID-19 immunisation. On 04Jun2021 at 11:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) intramuscular in the left arm for COVID-19 immunization at the health clinic. On 10Jun2021 (6 days after the vaccination), the patient experienced consciousness disturbed with prolonged pyrexia, sepsis and Disseminated intravascular coagulation (DIC). Pyrexia continued and consciousness disturbed was observed in the morning of 10Jun2021. Therefore the patient was urgently transported to the medical facility. Blood culture test performed after admission showed positive results for Escherichia coli and severe fever with thrombocytopenia symdrome (SFTS). The patient died of sepsis and disseminated intravascular coagulation (DIC) on 13Jun2021. The events resulted in emergency room/department visit or urgent care, hospitalization and death. The patient was hospitalized for four days. The outcome of the events was fatal with treatment including infusion and administration of antibiotic. Autopsy was not performed.; Sender''s Comments: Based on the temporal relationship, the association between the fatal events sepsis, disseminated intravascular coagulation, pyrexia, and altered state of consciousness with COMIRANTY use can not 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.; Reported Cause(s) of Death: pyrexia; Consciousness disturbed; Sepsis; DIC

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