이상반응 보고
| VAERS ID | 2247492 |
|---|---|
| 성별 | 여성 |
| 나이 | 64세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 939676CDC |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-07-14 |
| 발병일 | 2021-07-15 |
| 상태 |
증상
- 피로(Fatigue)
- 식욕 감소(Decreased appetite)
- 안면 마비(Facial paralysis)
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임상 검사
증상 상세
Fatigue; Loss of appetite; Facial palsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Apr-2022 and was forwarded to Moderna on 13-Apr-2022.
This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), DECREASED APPETITE (Loss of appetite) and FACIAL PARALYSIS (Facial palsy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
939676-CDC) for COVID-19 vaccination.
No Medical History information was reported.
On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .
5 milliliter.
On 15-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite) (seriousness criterion medically significant) and FACIAL PARALYSIS (Facial palsy) (seriousness criterion medically significant).
At the time of the report, FATIGUE (Fatigue), DECREASED APPETITE (Loss of appetite) and FACIAL PARALYSIS (Facial palsy) had resolved with sequelae.
Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No concomitant medication was reported.
March 29, 2022: To receive the first dose of Moderna vaccine, Patient went to the Health Center.
After the vaccination, the patient could not close the mouth and eyes.
On July 22, as the symptoms did not improve and became worse, the patient was sent to the emergency department of the Hospital and was diagnosed to have facial paralysis.
The patient was hospitalized for one week.
After returning home, the patient lost appetite and had fatigue, which resulted in gastrointestinal diseases and was re-admitted again.
At present, seventy percent of the left facial nerve paralysis was recovered and the patient did not return to the Hospital for follow-up.
At present, the patient is receiving rehabilitation therapy No treatment information was reported.
Company comment:This regulatory authority case concerns a 64 year old female patient with no reported medical history, who experienced the expected serious (important medical event) AESI of Facial paralysis; unexpected serious (important medical event) events of Fatigue and Decreased appetite on the next day of receiving the first dose of COVID -19 vaccination with mRNA-1273 vaccine.
After the vaccination, the patient could not close the mouth and eyes.
As the symptoms did not improve, she consulted the emergency department and was diagnosed with left Facial nerve paralysis.
The patient had lost appetite and developed fatigue.
The patient is on rehabilitation therapy.
The outcome of the events was resolved with sequelae'.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness retained as per Regulatory Authority reporting.
; Sender's Comments: This regulatory authority case concerns a 64 year old female patient with no reported medical history, who experienced the expected serious (important medical event) AESI of Facial paralysis; unexpected serious (important medical event) events of Fatigue and Decreased appetite on the next day of receiving the first dose of COVID -19 vaccination with mRNA-1273 vaccine.
After the vaccination, the patient could not close the mouth and eyes.
As the symptoms did not improve, she consulted the emergency department and was diagnosed with left Facial nerve paralysis.
The patient had lost appetite and developed fatigue.
The patient is on rehabilitation therapy.
The outcome of the events was resolved with sequelae'.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness retained as per Regulatory Authority reporting.