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VAERS ID	2160375
성별	여성
나이
주 코드	FR
제약회사	PFIZER\BIONTECH
로트 번호
예방접종 횟수	1
접종일	2021-12-13
발병일	2021-12-28
상태	입원 사망

증상

림프구 백분율(Lymphocyte percentage)
호중구 백분율(Neutrophil percentage)
혈당(Blood glucose)
C 반응성 단백질(C-reactive protein)
혈액 알부민(Blood albumin)
폐렴(Pneumonia)
혈압 측정(Blood pressure measurement)
혈액 크레아티닌(Blood creatinine)
체온(Body temperature)
혈액 젖산(Blood lactic acid)
심박수(Heart rate)
산소 포화도(Oxygen saturation)
호흡(Respiratory rate)
세균 검사(Bacterial test)
혈액 칼륨(Blood potassium)
급성 호흡 부전(Acute respiratory failure)
헤모글로빈(Haemoglobin)
백혈구 수(White blood cell count)
적혈구 소변(Red blood cells urine)
혼수상태 비늘(Coma scale)
백혈구 소변(White blood cells urine)
포도당 소변(Glucose urine)
소변 케톤체(Urine ketone body)
요로 잠혈(Urinary occult blood)

이환 중 질병

지병

Medical History/Concurrent Conditions: COPD; CVA; Hemorrhage brain; Senile dementia

기타 의료

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임상 검사

Test Date: 20211228; Test Name: Bacteria urine; Result Unstructured Data: Test Result:3+; Test Date: 20211228; Test Name: Albumin; Result Unstructured Data: Test Result:2.
8 g/dl; Test Date: 20211228; Test Name: Creatinine; Test Result: 0.
9 mg/dl; Test Date: 20211228; Test Name: Glucose; Test Result: 145 mg/dl; Test Date: 20211228; Test Name: Lactic acid; Result Unstructured Data: Test Result:1.
7 mmol/L; Test Date: 20211228; Test Name: Potassium; Result Unstructured Data: Test Result:5.
73 mmol/L; Test Date: 20211228; Test Name: Blood pressure; Result Unstructured Data: Test Result:126/75 mmHg; Test Date: 20211228; Test Name: Body temperature; Result Unstructured Data: Test Result:36.
9 Centigrade; Test Date: 20211228; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:E2M2V2; Test Date: 20211228; Test Name: C-reactive protein; Test Result: 11.
59 mg/dl; Test Date: 20211228; Test Name: Glucose urine; Test Result: Negative ; Test Date: 20211228; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.
7 g/dl; Test Date: 20211228; Test Name: Pulse rate; Result Unstructured Data: Test Result:73; Comments: Units:{beats}/min; Test Date: 20211228; Test Name: Lymphocyte percentage; Test Result: 10.
4 %; Test Date: 20211228; Test Name: Segmented neutrophil percentage; Test Result: 82.
3 %; Test Date: 20211228; Test Name: Oxygen saturation; Test Result: 89 %; Test Date: 20211228; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:0-2/ HPF; Test Date: 20211228; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28; Comments: Units:{breaths}/min; Test Date: 20211228; Test Name: Urinary occult blood; Result Unstructured Data: Test Result:3+; Test Date: 20211228; Test Name: Urine ketone body; Test Result: Negative ; Test Date: 20211228; Test Name: White blood cells; Result Unstructured Data: Test Result:11600 /mm3; Test Date: 20211228; Test Name: White blood cells urine; Result Unstructured Data: Test Result:>100/ HPF

증상 상세

PNEUMONIA; ACUTE RESPIRATORY FAILURE; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party (BioNTech SE) and Regulatory Authority.
Regulatory number: TW-TFDA-TVS-1110001219.
Other Case identifier: TW-Fosun-2022FOS002219.
This is a spontaneous report received from a non-contactable HCP received via a regulatory authority.
The regulatory authority report number is TW-TFDA-TVS-1110001219.
An 89-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 13-Dec-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization.
Concomitant of medical history included old cerebral vascular accident (CVA), senile dementia, hemorrhagic cerebrovascular disease (HCVD) and chronic obstructive pulmonary disease (COPD), which regularly followed up at the out-patient department (OPD).
The patient could not take care of herself and be lived in nursing.
Concomitant medications and past product were not reported.
The patient experienced pneumonia and acute respiratory failure on 28-Dec-2021.
On 28-Dec-2021, the patient suffered from shortness of breath, dyspnea, cough with sputum, desaturation noted.
Therefore, the patient was sent to the hospital for further management.
Upon arrival to the emergency room (ER), Glasgow coma scale (GCS): E2M2V2.
Initial vital signs showed blood pressure (BP): 126/75 mmHg; pulse rate (PR):73 times/min; respiratory rate (RR): 28 times/min; body temperature (BT): 36.
9 celsius ; SPO2 (oxygen saturation): 89%.
The laboratory data revealed complete blood count (CBC)/ differential count (DC): white blood cells (WBC): 11600/ul; Hemoglobin (Hb): 7.
7g/dl; Segmented neutrophil percentage (Seg Neutrophil): 82.
3%; Lymphocyte percentage:10.
4%; SMA: AC; sugar:145mg/dl; C-reactive protein (CRP): 11.
59mg/dL; Creatinine: 0.
9mg/dl; potassium (K) : 5.
73mmol/L; Albumin: 2.
8g/dL; Lactic acid: 1.
7mmol/L.
Urine routine showed: White blood cells urine (WBC): >100/ HPF; Red blood cells urine (RBC):0-2/ HPF; bacteria urine: 3+; urinary occult blood: 3+; glucose urine: -; urine ketone body: -.
The patient was admitted to the hospital for further treatment and evaluation due to the above conditions.
Pneumonia and acute respiratory failure met the seriousness criterion of Caused Hospitalization and Results in Death.
The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable.
At the time of the report, the outcomes of the events were fatal.
The patient died on an unknown date.
It was unknown if autopsy was performed.
Initial report was received on 16-Feb-2022.
Follow-up closed, no further information is possible.
BioNTech SE Comment: The medical review comments on the report of pneumonia and acute respiratory failure is as follows: The seriousness of pneumonia and acute respiratory failure is: hospitalization and results in death.
Pneumonia and acute respiratory failure are not common adverse events in the package insert of COMIRNATY, so the expectedness is: unexpected.
Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between pneumonia and acute respiratory failure and COMIRNATY are considered as possible.
BNT162B2 (COMIRNATY) is under agreement with BioNTech SE; Reported Cause(s) of Death: PNEUMONIA; ACUTE RESPIRATORY FAILURE