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This is VAERS ID 1439284

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First Appeared on 7/2/2021

VAERS ID: 1439284
VAERS Form:2
Age:85.0
Sex:Female
Location:Foreign
Vaccinated:2021-06-16
Onset:2021-06-16
Submitted:0000-00-00
Entered:2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 LA / OT

Administered by: Other      Purchased by: ??
Symptoms: Body temperature, Loss of consciousness, Pyrexia, Subarachnoid haemorrhage, Magnetic resonance imaging

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2021-06-19
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Headache; Hypertension; Reflux esophagitis
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210619; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results
CDC 'Split Type': JPPFIZER INC2021756997

Write-up: Subarachnoid haemorrhage; Loss of consciousness; Pyrexia of around 38 degrees centigrade; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 85-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included hypertension, dyslipidaemia, and reflux esophagitis. On 26May2021 at 10:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA4597, Expiration date 31Aug2021) intramuscular in the arm left at the age of 85-year-old as single dose for COVID-19 immunization. On 16Jun2021 at 10:15 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the arm left at the age of 85-year-old as single dose for COVID-19 immunization. On an unspecified date, the patient experienced subarachnoid haemorrhage. The outcome of the event was fatal. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: On 10Jun2021, the patient had intense headache. On 16Jun2021, the patient developed pyrexia of around 38 degrees centigrade. On 19Jun2021, the patient experienced loss of consciousness while undergoing MRI and subsequently died. The patient died on 19Jun2021. The outcome of loss of consciousness and pyrexia was unknown. An autopsy was unknown performed and the reported cause of death was subarachnoid haemorrhage. The reporting physician classified the event as serious (death).; Sender''s Comments: Based on a plausible temporal association only, a causative role of BNT162B2 vaccine for the reported subarachnoid haemorrhage (fatal) and loss of consciousness cannot be completely excluded. The mentioned hypertension and the patient''s age are considered significant risk factors for the fatal event. 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: Subarachnoid haemorrhage

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