이상반응 보고
| VAERS ID | 2516516 |
|---|---|
| 성별 | 남성 |
| 나이 | 76세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 008H21A |
| 예방접종 횟수 | 2 |
| 접종일 | 2022-01-06 |
| 발병일 | 2022-10-17 |
| 상태 | 사망 |
증상
- 호흡곤란(Dyspnoea)
- 가슴 통증(Chest pain)
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DIFFICULTY OF BREATHING; CHEST PAIN; This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (CHEST PAIN) and DYSPNOEA (DIFFICULTY OF BREATHING) in a 76-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no.
008H21A) for COVID-19 prophylaxis.
Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.
No Medical History information was reported.
On 06-Jan-2022, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form.
On 10-May-2022, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form.
On 17-Oct-2022, the patient experienced CHEST PAIN (CHEST PAIN) (seriousness criterion death).
On 07-Nov-2022, the patient experienced DYSPNOEA (DIFFICULTY OF BREATHING) (seriousness criterion death).
The reported cause of death was Chest pain and difficulty of breathing.
It is unknown if an autopsy was performed.
For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.
No concomitant medications details were reported.
The lab test and corrective treatment data was not provided.
Company Comment: This regulatory case concerns a 76-year-old male patient with no medical history reported, who experienced the serious, unexpected (fatal) events of chest pain approximately 5 months 7 days and Dyspnoea 5 months 28 days after receiving the second dose of mRNA-1273 Vaccine.
The date of death, clinical course of events, autopsy report, exact cause of death, diagnostic and treatment details are not provided.
Patient received the first dose of Janssen vaccine 5 months back.
The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Events' seriousness assessed as per Regulatory Authority reporting.
; Sender's Comments: This regulatory case concerns a 76-year-old male patient with no medical history reported, who experienced the serious, unexpected (fatal) events of chest pain approximately 5 months 7 days and Dyspnoea 5 months 28 days after receiving the second dose of mRNA-1273 Vaccine.
The date of death, clinical course of events, autopsy report, exact cause of death, diagnostic and treatment details are not provided.
Patient received the first dose of Janssen vaccine 5 months back.
The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Events' seriousness assessed as per Regulatory Authority reporting.
; Reported Cause(s) of Death: chest pain; Difficulty of breathing