이상반응 보고
| VAERS ID | 2247535 |
|---|---|
| 성별 | 남성 |
| 나이 | 42세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2022-04-07 |
| 발병일 | 2022-04-08 |
| 상태 | 입원 |
증상
- 통증(Pain)
- 무력증(Asthenia)
- 졸도(Syncope)
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임상 검사
증상 상세
Faint; General pain and weakness; General pain and weakness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Apr-2022 and was forwarded to Moderna on 13-Apr-2022.
This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Faint), PAIN (General pain and weakness) and ASTHENIA (General pain and weakness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
No Medical History information was reported.
On 07-Apr-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.
On 08-Apr-2022, the patient experienced SYNCOPE (Faint) (seriousness criterion hospitalization), PAIN (General pain and weakness) (seriousness criterion hospitalization) and ASTHENIA (General pain and weakness) (seriousness criterion hospitalization).
At the time of the report, SYNCOPE (Faint), PAIN (General pain and weakness) and ASTHENIA (General pain and weakness) was resolving.
The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
The administration of the first dose of Moderna.
On April 8, 2022, the patient had dizziness, general pain, weakness and chills began.
Then the patient came to the outpatient department of hospital for treatments.
BT: 36.
8; WBC: 13070; R/O SEPSIS.
The doctor suggested hospitalization for observation and treatment.
No concomitant product was provided.
COMPANY COMMENT: This is a regulatory authority case concerning a 42 -years-old male patient with no clinical history who experienced the unexpected events of SYNCOPE, PAIN and ASTHENIA 2 days after the 1st dose of mRNA-1273 vaccine.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Terms and onset were captured as provided.
The case was assessed as serious by the Regulatory Authority´s report due to hospitalization; Sender's Comments: COMPANY COMMENT: This is a regulatory authority case concerning a 42 -years-old male patient with no clinical history who experienced the unexpected events of SYNCOPE, PAIN and ASTHENIA 2 days after the 1st dose of mRNA-1273 vaccine.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Terms and onset were captured as provided.
The case was assessed as serious by the Regulatory Authority´s report due to hospitalization