이상반응 보고
| VAERS ID | 2247527 |
|---|---|
| 성별 | 남성 |
| 나이 | 57세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-11-16 |
| 발병일 | 2021-12-06 |
| 상태 |
증상
- 발진(Rash)
- 가려움증(Pruritus)
이환 중 질병
지병
Comments: The Patient had concurrent history of chronic kidney disease stage 5, diabetes mellitus and hypertension.
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
Skin itching; Skin rash (non-injection site); This regulatory authority case was reported by an other health care professional and describes the occurrence of PRURITUS (Skin itching) and RASH (Skin rash (non-injection site)) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
The Patient had concurrent history of chronic kidney disease stage 5, diabetes mellitus and hypertension.
.
On 16-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.
On 06-Dec-2021, the patient experienced PRURITUS (Skin itching) (seriousness criterion medically significant) and RASH (Skin rash (non-injection site)) (seriousness criterion medically significant).
At the time of the report, PRURITUS (Skin itching) and RASH (Skin rash (non-injection site)) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No concomitant medications were provided.
The patient age was reported as 58 years old.
It was reported that on 06-Dec-2021, patient developed Generalized skin rash with generalized itching and bulla formation.
Patient went to Dermatology OPD on March 31, 2022.
Suspected Moderna caused bullous pemphigoid.
The Outcome of Adverse Reactions were reported as Being recovered or Solution in progress.
The Characterization of Drug Role was reported as Suspected.
No treatment details were reported.
Company comment: This Regulatory Authority case concerns a 57-year-old, male patient, with current history of chronic kidney disease stage 5, who experienced the unexpected, serious (Medically significant) events of pruritus and rash that occurred approximately 20 days after receiving the second dose of mRNA-1273 vaccine.
Current history of chronic kidney disease stage 5 remains as a confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Events seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.
; Sender's Comments: This Regulatory Authority case concerns a 57-year-old, male patient, with current history of chronic kidney disease stage 5, who experienced the unexpected, serious (Medically significant) events of pruritus and rash that occurred approximately 20 days after receiving the second dose of mRNA-1273 vaccine.
Current history of chronic kidney disease stage 5 remains as a confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Events seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.