이상반응 보고
| VAERS ID | 2247502 |
|---|---|
| 성별 | 남성 |
| 나이 | 56세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 2011685_1110305 |
| 예방접종 횟수 | 3 |
| 접종일 | 2022-02-10 |
| 발병일 | 2022-02-17 |
| 상태 |
증상
- 호흡곤란(Dyspnoea)
이환 중 질병
지병
Medical History/Concurrent Conditions: Type 2 diabetes mellitus (for 10 years, and followed up)
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
Dyspnea; This regulatory authority case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Dyspnea) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
2011685_1110305CDC) for COVID-19 vaccination.
Concurrent medical conditions included Type 2 diabetes mellitus (for 10 years, and followed up).
On 10-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .
25 milliliter.
On 17-Feb-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Dyspnea) (seriousness criterion medically significant).
At the time of the report, DYSPNOEA (Dyspnea) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient had no allergies.
Concomitant medications were not reported.
The first dose of COVID-19 vaccine AZ was administered on 29-Jul-2021.
Because of palpitation and fever up to 39°C, the patient came to the emergency department of hospital for consultations.
The second dose of COVID-19 vaccine AZ was administered on 15-Oct-2021.
After receiving Moderna vaccine, patient had dyspnea, discomfort, dizziness, and weak feet occurred, for 5-6 times a day.
As the symptoms continued to become serious, which occurred for 7-8 times a day and the patient would gasp when climbing stairs (the patient was healthy and would not gasp afar walking for a few kilometers previously), the patient come to the medical clinic of hospital in the afternoon.
Blood test was carried out, with LDH: 84 U/L; CK: 65 U/L; CK-MB mass: 1.
3 ng/ml; hs TnI : 19.
4 pg/ml.
As the TnI was slightly high, the patient was referred to the cardiology department for further evaluation.
On 07-Apr-2022, it was informed that, the patient complained of gasping still there, and the patient dared not to move around since the patient gasped after getting up that morning, and onset occurred from time to time.
No treatment information was provided by the reporter.
At the time of report, the patient still had gasping, dyspnea, discomfort and weak feet.
It was estimated that the patient would return to the hospital in the afternoon.
Company comment- This regulatory case concerns a 56-year-old male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Dyspnoea 7 days after third dose of mRNA-1273 Vaccine administration.
Patient experienced dyspnoea,, discomfort, dizziness and weak feet 5 to 6 times a day a week after vaccination.
As the symptoms were persistent with worsening of exertional dyspnoea(which was not there before), approximately one month 13 days later patient consulted his clinic.
Blood test done showed LDH-84 U/L, CK-65 U/L, CK-MB mass-1.
3ng/ml, hs Tn I-19.
4pg/ml.
As Tn I was slightly high referred to cardiologist.
No further treatment details was provided.
On follow up call, patient still experiences Dyspnoea on and off with gasping, discomfort and weak feet and is for further consultation with physician.
At the time of the reporting, outcome of the event was resolving.
The patient had received initial schedule of vaccination with COVID-19 vaccine AZ (interchange of vaccine products) first dose on 29th July 2021 and second dose on 15th October 2021.
Benefit risk relationship of mRNA-1273 Vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report; Sender's Comments: This regulatory case concerns a 56-year-old male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Dyspnoea 7 days after third dose of mRNA-1273 Vaccine administration.
Patient experienced dyspnoea,, discomfort, dizziness and weak feet 5 to 6 times a day a week after vaccination.
As the symptoms were persistent with worsening of exertional dyspnoea(which was not there before), approximately one month 13 days later patient consulted clinic.
Blood test done showed LDH-84 U/L, CK-65 U/L, CK-MB mass-1.
3ng/ml, hs Tn I-19.
4pg/ml.
As Tn I was slightly high referred to cardiologist.
No further treatment details was provided.
On follow up call, patient still experiences Dyspnoea on and off with gasping, discomfort and weak feet and is for further consultation with physician.
At the time of the reporting, outcome of the event was resolving.
The patient had received initial schedule of vaccination with COVID-19 vaccine AZ (interchange of vaccine products) first dose on 29th July 2021 and second dose on 15th October 2021.
Benefit risk relationship of mRNA-1273 Vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.