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VAERS ID 1504945
성별 여성
나이 78세
주 코드 FR
제약회사 PFIZER\BIONTECH
로트 번호 FD0927
예방접종 횟수 1
접종일 2021-06-25
발병일 2021-06-26
상태 입원 사망
증상
  • 설사(Diarrhoea)
  • 호흡곤란(Dyspnoea)
  • 무력증(Asthenia)
  • 보행불능(Gait inability)
  • 실어증(Aphasia)
  • 병(Illness)
  • 평균 세포 헤모글로빈(Mean cell haemoglobin)
  • 혈액 크레아티닌(Blood creatinine)
  • 혈액 요소(Blood urea)
  • 죽음(Death)
  • 혈소판 수(Platelet count)
  • 적혈구 분포 폭(Red cell distribution width)
  • 혈액 칼륨(Blood potassium)
  • 헤모글로빈(Haemoglobin)
  • 평균 세포 헤모글로빈 농도(Mean cell haemoglobin concentration)
  • 백혈구 수(White blood cell count)
  • 헤마토크릿(Haematocrit)
  • 급성 호흡기 장애 증후군(Acute respiratory distress syndrome)
  • 적혈구 수(Red blood cell count)
  • 평균 혈소판 부피(Mean platelet volume)
  • 혈액 나트륨(Blood sodium)
  • 혈액 염화물(Blood chloride)
  • 평균 세포 부피(Mean cell volume)

이환 중 질병

지병

Medical History/Concurrent Conditions: Arthritis; Hypertension (on treatment)

기타 의료

이전 예방접종

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임상 검사

Test Date: 20210703; Test Name: Chloride; Result Unstructured Data: Test Result:108 mmol/L; Comments: increased; Test Date: 20210703; Test Name: Creatinine; Result Unstructured Data: Test Result:439 umol/l; Comments: increased; Test Date: 20210703; Test Name: Potassium; Result Unstructured Data: Test Result:6.
6 mmol/L; Comments: increased; Test Date: 20210703; Test Name: Sodium; Result Unstructured Data: Test Result:160 mmol/L; Comments: increased; Test Date: 20210703; Test Name: Urea; Result Unstructured Data: Test Result:greater than 40 mmol/L; Comments: increased; Test Date: 20210703; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:8 ml/min; Test Date: 20210703; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.
456 L/L; Test Date: 20210703; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.
4 g/dl; Test Date: 20210703; Test Name: MCH; Test Result: 13.
4 pg; Test Date: 20210703; Test Name: MCHC; Result Unstructured Data: Test Result:31.
6 g/dl; Test Date: 20210703; Test Name: MCV; Result Unstructured Data: Test Result:102.
5 fL; Comments: increased; Test Date: 20210703; Test Name: mean platelet volume; Result Unstructured Data: Test Result:12; Test Date: 20210703; Test Name: Platelet count; Result Unstructured Data: Test Result:139; Comments: decreased; Test Date: 20210703; Test Name: Red blood cell count; Result Unstructured Data: Test Result:4.
45 x10 12/l; Test Date: 20210703; Test Name: red cell distribution width; Test Result: 15.
3 %; Test Date: 20210703; Test Name: White blood cell count; Result Unstructured Data: Test Result:13.
73 x10 9/l; Comments: increased

증상 상세

Acute respiratory distress syndrome; Shortness of breath; Ill looking; Weak; Diarrhea; Unable to talk; Unable to walk; Died; This is a spontaneous report from a contactable other hcp.
A 78-year-old female patient received BNT162B2 (COMIRNATY, formulation: solution for injection, Lot Number: FD0927, Expiration Date: Sep2021) via an unspecified route of administration on 25Jun2021 at 14:16 as dose 1, single for Covid-19 immunization.
The patients medical history included hypertension; on treatment and arthritis.
The patients concomitant medications were not reported.
On 26Jun2021 patient experienced illness, weakness, diarrhoea, unable to talk, unable to walk, shortness of breath and acute respiratory distress syndrome.
Patient was admitted to hospital on 03Jul2021.
On 04Jul2021 at 02:40, patient died.
An autopsy was not performed.
The patient underwent lab tests and procedures on 03Jul2021 which included blood chloride: 108 mmol/l, increased; blood creatinine: 439 micromole/ litre (umol/l), increased; blood potassium: 6.
6 millimoles/litre (mmol/l), increased; blood sodium: 160 mmol/l, increased; blood urea: greeter than 40 mmol/l, increased; glomerular filtration rate: 8 Millilitre/minute (ml/min), haematocrit: 0.
456 litre/litre (l/l), haemoglobin: 14.
4 grams/decilitre (g/dl), mean cell haemoglobin: 13.
4 picograms (pg), mean cell haemoglobin concentration: 31.
6 g/dl, mean cell volume: 102.
5 femtoliters (fl), increased; mean platelet volume: 12, platelet count: 139, decreased; red blood cell count: 4.
45 x10 12/l, White blood cell count: 3.
90 x10 9/l, increased; red cell distribution width: 15.
3 percent.
The outcome of event was fatal and outcome of all other event was unknown.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of ARDS, DEATH and suspect drug BNT162B2 cannot be 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: Died