이상반응 보고
| VAERS ID | 2247512 |
|---|---|
| 성별 | 남성 |
| 나이 | 68세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2022-02-15 |
| 발병일 | 2022-02-27 |
| 상태 | 입원 |
증상
- 가슴 통증(Chest pain)
- 부종(Oedema)
- 부정맥(Arrhythmia)
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증상 상세
Arrythmia, chest pain and edema; Arrythmia, chest pain and edema; Arrythmia, chest pain and edema; This regulatory authority case was reported by an other health care professional and describes the occurrence of ARRHYTHMIA (Arrythmia, chest pain and edema), CHEST PAIN (Arrythmia, chest pain and edema) and OEDEMA (Arrythmia, chest pain and edema) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
No Medical History information was reported.
On 15-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 27-Feb-2022, the patient experienced ARRHYTHMIA (Arrythmia, chest pain and edema) (seriousness criterion hospitalization), CHEST PAIN (Arrythmia, chest pain and edema) (seriousness criterion hospitalization) and OEDEMA (Arrythmia, chest pain and edema) (seriousness criterion hospitalization).
At the time of the report, ARRHYTHMIA (Arrythmia, chest pain and edema), CHEST PAIN (Arrythmia, chest pain and edema) and OEDEMA (Arrythmia, chest pain and edema) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
On 15 March 2022, reported that in patient complained of post Moderna chest pain, dyspnea, cough, wheezing, no hemoptysis.
Treatment included 15 mg Xarelto tab 1 tab QDCC and 5 mg Bisoprolol tab 0.
5 tab QD for 14 days.
On 17 March 2022 in CV OPD, Lanoxin tab (Oral) 0.
25 mg 0.
5-tab QD, 100 mg Entresto tab 1-tab BIDPC and (Oral) Rosis tab 40 mg 1-tab QD were prescribed for 14 days.
On March 25, 2022, in NEPH OPD: suspected Moderna COVID-19 Vaccine related pericarditis.
Prescribed Silymarin tab 35 mg 2-tab TID, 120 mL (C) B.
M.
sol 5 mL TID and Spironolactone-25 1-tab BIDPRN for 7 days and admission.
Relevant concomitant product usage were not reported by the reporter.
Company comment-This regulatory case concerns a 68-year-old male patient with no medical history reported, who experienced the unexpected serious (Hospitalization) events of Arrhythmia (AESI), Chest pain and Oedema after second dose of mRNA-1273 Vaccine administration.
Patient experienced chest pain, dyspnoea, cough and wheezing post Moderna.
In CV OPD, treated with Tab.
Xarelto15mg QDCC, Tab.
Bisoprolol 5mg ½ QD for 14 days.
Two days later, in CV OPD treated with Tab Lanoxin 0.
25 mg ½ QD, Tab.
Entresto 100mg BIDPC, Tab.
Rosis40 mg QD, for 14 days.
On March 25th 2022 in NEPH OPD, suspected Vaccine related Pericarditis and was advised admission along with Tab.
Silymarin 35 mg 2 tab TID, B.
M sol.
5 ml TID, Tab.
Spironolactone 25 mg BIDPRN for 7 days.
No further Lab details provided.
Outcome of the events was resolving at the time of report.
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 68-year-old male patient with no medical history reported, who experienced the unexpected serious (Hospitalization) events of Arrhythmia (AESI), Chest pain and Oedema after second dose of mRNA-1273 Vaccine administration.
Patient experienced chest pain, dyspnoea, cough and wheezing post Moderna.
In CV OPD, treated with Tab.
Xarelto15mg QDCC, Tab.
Bisoprolol 5mg ½ QD for 14 days.
Two days later, in CV OPD treated with Tab Lanoxin 0.
25 mg ½ QD, Tab.
Entresto 100mg BIDPC, Tab.
Rosis40 mg QD, for 14 days.
On March 25th 2022 in NEPH OPD, suspected Vaccine related Pericarditis and was advised admission along with Tab.
Silymarin 35 mg 2 tab TID, B.
M sol.
5 ml TID, Tab.
Spironolactone 25 mg BIDPRN for 7 days.
No further Lab details provided.
Outcome of the events was resolving at the time of report.
Benefit risk relationship of mRNA-1273 Vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.