이상반응 보고

VAERS ID	2247507
성별	여성
나이	29세
주 코드	FR
제약회사	MODERNA
로트 번호
예방접종 횟수	2
접종일	2022-02-23
발병일	2022-03-31
상태	입원

증상

• 두통(Headache)
• 오한(Chills)
• 근육통(Myalgia)

이환 중 질병

Polymyositis (History of polymyositis)

지병

기타 의료

이전 예방접종

알레르기

임상 검사

증상 상세

headache; Muscle pain; Chill; This regulatory authority case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), MYALGIA (Muscle pain) and CHILLS (Chill) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
Concurrent medical conditions included Polymyositis (History of polymyositis).
On 23-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 31-Mar-2022, the patient experienced HEADACHE (headache) (seriousness criterion hospitalization), MYALGIA (Muscle pain) (seriousness criterion hospitalization) and CHILLS (Chill) (seriousness criterion hospitalization).
At the time of the report, HEADACHE (headache), MYALGIA (Muscle pain) and CHILLS (Chill) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter's causality assessment was reported as suspected for all events.
.
No concomitant medication was reported.
After receiving the third dose of Moderna in the clinic on 23-Feb-2022, the patient developed fever symptoms the next day and went to the clinic for treatments without remission.
Until 15-Mar-2022, due to fever, severe headache and systemic muscle pain, the patient went to the emergency department of Hospital for treatment.
On 1-Mar-2022, the patient was admitted to the general medical ward for treatment, and then was discharged on 25-Mar-2022, and continuous outpatient follow-up will be carried out.
The following was the follow-up outcome.
On 31-Mar-2022: The symptoms of the patient have been relieved and the patient was discharged from the hospital.
The case will be closed after uploading the disease abstract.
No treatment information was reported.
Company Comment: This regulatory case concerns a 29-year-old female patient with Concurrent medical conditions of Polymyositis (History of polymyositis), who experienced the unexpected serious events of Headache, Myalgia and Chills (seriousness criteria hospitalization) after receiving a dose of mRNA-1273 vaccine.
The patient was hospitalized 7 days after the vaccination due to fever, severe headache and systemic muscle pain.
She was treated and discharged from hospital 25 days later, with continuous outpatient follow-up.
Patient's concurrent medical conditions of Polymyositis could be confounder for Myalgia.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The events were assessed as serious as per Regulatory Authority´s report.
; Sender's Comments: This regulatory case concerns a 29-year-old female patient with Concurrent medical conditions of Polymyositis (History of polymyositis), who experienced the unexpected serious events of Headache, Myalgia and Chills (seriousness criteria hospitalization) after receiving a dose of mRNA-1273 vaccine.
The patient was hospitalized 7 days after the vaccination due to fever, severe headache and systemic muscle pain.
She was treated and discharged from hospital 25 days later, with continuous outpatient follow-up.
Patient's concurrent medical conditions of Polymyositis could be confounder for Myalgia.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The events were assessed as serious as per Regulatory Authority´s report.