이상반응 보고
| VAERS ID | 2013359 |
|---|---|
| 성별 | 남성 |
| 나이 | 81세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 3003604 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-12-01 |
| 발병일 | 2021-12-01 |
| 상태 | 사망 |
증상
- 관절통(Arthralgia)
- 피로(Fatigue)
- 주사 부위 통증(Injection site pain)
- 근육통(Myalgia)
- 죽음(Death)
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임상 검사
증상 상세
Death; Injection site pain; Fatigue; Arthralgia; Myalgia; This case was received via Regulatory Authority (Reference number: LV-SAM-2021127292) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021.
This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no.
3003604) for COVID-19 vaccination.
The occurrence of additional non-serious events is detailed below.
No Medical History information was reported.
On 01-Dec-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .
5 ml.
On 01-Dec-2021, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia) and INJECTION SITE PAIN (Injection site pain).
The patient died on 02-Dec-2021.
The cause of death was not reported.
An autopsy was not performed.
At the time of death, FATIGUE (Fatigue), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.
No concomitant medications were provided.
No treatment information was provided.
Company comment: This is a regulatory case concerning an 81 year-old, male patient with no reported medical history, who experienced the serious unexpected, according CCDS, event of death.
The patient died 1 day after receiving the second dose of mRNA-1273 vaccine, an autopsy was not performed and cause of death was not further specified.
The non serious events of fatigue, arthralgia, myalgia and injection site pain were also reported in the case.
The rechallenge was not applicable due to the fatal outcome.
Patient´s advanced age remains a confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This is a regulatory case concerning an 81 year-old, male patient with no reported medical history, who experienced the serious unexpected, according CCDS, event of death.
The patient died 1 day after receiving the second dose of mRNA-1273 vaccine, an autopsy was not performed and cause of death was not further specified.
The non serious events of fatigue, arthralgia, myalgia and injection site pain were also reported in the case.
The rechallenge was not applicable due to the fatal outcome.
Patient´s advanced age remains a confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Reported Cause(s) of Death: Death