이상반응 보고
| VAERS ID | 2247525 |
|---|---|
| 성별 | 남성 |
| 나이 | 32세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2022-03-14 |
| 발병일 | 2022-03-21 |
| 상태 | 입원 |
증상
- 근육 약화(Muscular weakness)
- 뇌출혈(Cerebral haemorrhage)
이환 중 질병
지병
Comments: Patient had hypertension for 4 years without drug control and had no drug allergy.
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임상 검사
증상 상세
Cerebral hemorrhage; Limb weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral hemorrhage) and MUSCULAR WEAKNESS (Limb weakness) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
Patient had hypertension for 4 years without drug control and had no drug allergy.
On 14-Mar-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 21-Mar-2022, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral hemorrhage) (seriousness criterion hospitalization) and MUSCULAR WEAKNESS (Limb weakness) (seriousness criterion hospitalization).
At the time of the report, CEREBRAL HAEMORRHAGE (Cerebral hemorrhage) and MUSCULAR WEAKNESS (Limb weakness) had not resolved.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient was a 31-year-old male patient.
No concomitant medications reported.
According to the complaint made by the family member, the patient went to Hospital for consultations and treatments due to unclear speech and weakness of the right limb at 4:00 PM on 20-Mar and was diagnosed to have spontaneous brainstem hemorrhage.
To facilitate care by the family member, the patient was transferred back to a different hospital for emergency treatment.
Two doses of Moderna vaccine were administered on 08-Feb-2022 and 14-Mar2022.
On 21-Mar, the coma index was 14 points for E4V4M6, the body temperature was 36.
6 Degree Celsius, the heart rate was 117 BPM, the respiratory rate was 20 times/min, the blood pressure was 150/85 mmHg, the blood oxygen was 97 percentage, the pupil size was 3 (Plus or minus) / 3 (Plus or minus) for the left / right eye, and the results in routine lab tests were WBC was 17540K, Na was 13, K was 4.
0, PT was 9.
6, APTT was 26.
3, Troponin I was 0.
037, CPK was 201, CKMB was 16, Chest X-ray showed no lung infiltration, ECG showed Sinus tachycardia, Heart rate was 109 BPM, Head computed tomography showed Brain stem hemorrhage and the patient was admitted to the intensive care unit of the hospital.
No treatment medication details reported.
Company Comment: This regulatory case concerns a 32-year-old male patient with medical history of hypertension for 4 years without drug control, who experienced the unexpected serious AESI of Cerebral haemorrhage and unexpected serious event of Muscular weakness (seriousness criteria hospitalization) which occurred 6 days after receiving the second dose of mRNA-1273 vaccine.
Its reported that 6 days after the vaccination patient went to hospital due to unclear speech and weakness of the right limb and was diagnosed to have spontaneous brainstem hemorrhage.
The coma index was 14 points for E4V4M6, the body temperature was 36.
6 Degree Celsius, the heart rate was 117 BPM, the respiratory rate was 20 times/min, the blood pressure was 150/85 mmHg, the blood oxygen was 97 percentage, the pupil size was 3 (Plus or minus) / 3 (Plus or minus) for the left / right eye, and the results in routine lab tests were WBC was 17540K, Na was 13, K was 4.
0, PT was 9.
6, APTT was 26.
3, Troponin I was 0.
037, CPK was 201, CKMB was 16, Chest X-ray showed no lung infiltration, ECG showed Sinus tachycardia, Heart rate was 109 BPM, Head computed tomography showed Brain stem hemorrhage and the patient was admitted to the intensive care unit of the hospital.
Patients medical history of hypertension for 4 years without drug control could be confounding for Cerebral haemorrhage.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The events were assessed as serious as per Regulatory Authority´s report.
; Sender's Comments: This regulatory case concerns a 32-year-old male patient with medical history of hypertension for 4 years without drug control, who experienced the unexpected serious AESI of Cerebral haemorrhage and unexpected serious event of Muscular weakness (seriousness criteria hospitalization) which occurred 6 days after receiving the second dose of mRNA-1273 vaccine.
Its reported that 6 days after the vaccination patient went to hospital due to unclear speech and weakness of the right limb and was diagnosed to have spontaneous brainstem hemorrhage.
The coma index was 14 points for E4V4M6, the body temperature was 36.
6 Degree Celsius, the heart rate was 117 BPM, the respiratory rate was 20 times/min, the blood pressure was 150/85 mmHg, the blood oxygen was 97 percentage, the pupil size was 3 (Plus or minus) / 3 (Plus or minus) for the left / right eye, and the results in routine lab tests were WBC was 17540K, Na was 13, K was 4.
0, PT was 9.
6, APTT was 26.
3, Troponin I was 0.
037, CPK was 201, CKMB was 16, Chest X-ray showed no lung infiltration, ECG showed Sinus tachycardia, Heart rate was 109 BPM, Head computed tomography showed Brain stem hemorrhage and the patient was admitted to the intensive care unit of the hospital.
Patients medical history of hypertension for 4 years without drug control could be confounding for Cerebral haemorrhage.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The events were assessed as serious as per Regulatory Authority´s report.