이상반응 보고
| VAERS ID | 2168446 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | |
| 접종일 | |
| 발병일 | 2022-01-31 |
| 상태 | 후유증 |
증상
- 피로(Fatigue)
- 발열(Pyrexia)
- 두통(Headache)
- 메스꺼움(Nausea)
- 실신(Malaise)
- 근육통(Myalgia)
- 주사 부위 반응(Injection site reaction)
- 피부질환(Skin disorder)
이환 중 질병
Autoimmune disorder
지병
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
Feeling unwell; Skin Problem; Fever; nausea; Muscle pain; headache; Injection site response; fatigue; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2022-115995) on 03-Mar-2022 and was forwarded to Moderna on 03-Mar-2022.
This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), SKIN DISORDER (Skin Problem), PYREXIA (Fever), NAUSEA (nausea), MYALGIA (Muscle pain), HEADACHE (headache), INJECTION SITE REACTION (Injection site response) and FATIGUE (fatigue) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.
Concurrent medical conditions included Autoimmune disorder.
On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 31-Jan-2022, the patient experienced MALAISE (Feeling unwell) (seriousness criterion disability), SKIN DISORDER (Skin Problem) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), NAUSEA (nausea) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability), HEADACHE (headache) (seriousness criterion disability), INJECTION SITE REACTION (Injection site response) (seriousness criterion disability) and FATIGUE (fatigue) (seriousness criterion disability).
At the time of the report, MALAISE (Feeling unwell), SKIN DISORDER (Skin Problem), PYREXIA (Fever), NAUSEA (nausea), MYALGIA (Muscle pain), HEADACHE (headache), INJECTION SITE REACTION (Injection site response) and FATIGUE (fatigue) was resolving.
Concomitant drugs were not reported.
Treatment medications were not provided.
It was reported that side effects not completely gone yet.
Company comment This is a Regulatory case concerning an adult female patient with medical history of Autoimmune disorder, who experienced the serious (due to disability) unexpected events of Malaise, Skin Disorder, Pyrexia, Nausea, Myalgia, Headache, Injection Site Reaction and Fatigue.
The patient received a dose of mRNA-1273 on an unknown date.
Although onset dates of the events were provided, vaccination date was not; hence, latency cannot be assessed.
The mentioned medical history remains a confounder for Skin Disorder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2022: Translation received on 08-MAR-2022, event verbatim updated.
.
; Sender's Comments: This is a Regulatory case concerning an adult female patient with medical history of Autoimmune disorder, who experienced the serious (due to disability) unexpected events of Malaise, Skin Disorder, Pyrexia, Nausea, Myalgia, Headache, Injection Site Reaction and Fatigue.
The patient received a dose of mRNA-1273 on an unknown date.
Although onset dates of the events were provided, vaccination date was not; hence, latency cannot be assessed.
The mentioned medical history remains a confounder for Skin Disorder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.