이상반응 보고
| VAERS ID | 2247499 |
|---|---|
| 성별 | 여성 |
| 나이 | 37세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 3 |
| 접종일 | 2022-03-01 |
| 발병일 | 2022-03-17 |
| 상태 | 입원 |
증상
- 가슴 통증(Chest pain)
이환 중 질병
지병
기타 의료
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임상 검사
증상 상세
Chest pain; This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
No Medical History information was reported.
On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 17-Mar-2022, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization).
At the time of the report, CHEST PAIN (Chest pain) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient age was given as 37.
6 years.
Concomitant medication was not provided by reporter.
It was reported that after third dose of Moderna, later stated that there was chest tightness, chest pain, wheezing, cold sweat, and wound on the right thigh and the patient ever went to a clinic for the consultation and treatment, but there was no improvement till now.
On 17-Mar, the patient went to the emergency department of hospital for consultations and treatments as the symptoms did not improve.
After consultations, the patient was given N/S 500 ml, Diphenhydramine 30 mg 1 ml and Anxicam inj.
2 mg/ml 1 ml injection.
As the patient still felt chest tightness and chest pain, the patient was recommended to be hospitalized for observation and treatment.
On 30-Mar, the patient was allowed to be discharged from the hospital after being examined by the doctor.
On 31-Mar-2022, the follow-up outcome was the patient was called for follow-up and the family member of the patient said that the patient was discharged from the hospital on 30-Mar and had been resting after returning home.
The skin was still itchy and continued to be followed up.
On 04-Apr-2022, a phone call was made to the patient for follow-up, and the family member of the patient said that the skin of the thigh of the patient was not recovered and the patient had been sleeping all the time, and the patient had gone to the clinic for follow-up and continued treatments, and the patient was continually followed up.
Company comment: This is a regulatory case concerning a 37-year-old female patient with no medical history reported, who experienced the unexpected serious event of Chest pain, which led to hospitalization, 16 days after receiving a dose of mRNA-1273 as third dose of COVID-19 vaccine (no information disclosed on previous doses of COVID-19 vaccine).
Initially, patient experienced chest tightness, chest pain, wheezing, cold sweat, and wound on the right thigh, which prompted the patient to seek consultation and treatment in the clinic, however there was no improvement.
Eventually, patient went to the emergency department as the symptoms did not improved.
Patient was given Normal saline 500mL, Diphenhydramine 30 mg and Anxicam 2 mg/ml 1 ml injection.
As the patient still felt chest tightness and chest pain, patient was recommended to be hospitalized for observation and treatment.
After 13 days, patient was allowed to be discharged from the hospital.
However, patient skin was still itchy, skin of the thigh was not yet recovered, and patient had been sleeping all the time.
At the time of report, the event Chest pain was resolving.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Event's seriousness assessed as per Regulatory Authority's report.
; Sender's Comments: This is a regulatory case concerning a 37-year-old female patient with no medical history reported, who experienced the unexpected serious event of Chest pain, which led to hospitalization, 16 days after receiving a dose of mRNA-1273 as third dose of COVID-19 vaccine (no information disclosed on previous doses of COVID-19 vaccine).
Initially, patient experienced chest tightness, chest pain, wheezing, cold sweat, and wound on the right thigh, which prompted the patient to seek consultation and treatment in the clinic, however there was no improvement.
Eventually, patient went to the emergency department as the symptoms did not improved.
Patient was given Normal saline 500mL, Diphenhydramine 30 mg and Anxicam 2 mg/ml 1 ml injection.
As the patient still felt chest tightness and chest pain, patient was recommended to be hospitalized for observation and treatment.
After 13 days, patient was allowed to be discharged from the hospital.
However, patient skin was still itchy, skin of the thigh was not yet recovered, and patient had been sleeping all the time.
At the time of report, the event Chest pain was resolving.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Event's seriousness assessed as per Regulatory Authority's report.