이상반응 보고

VAERS ID	2247505
성별	여성
나이	74세
주 코드	FR
제약회사	MODERNA
로트 번호
예방접종 횟수	3
접종일	2022-02-15
발병일	2022-03-18
상태	입원

증상

• 사지의 통증(Pain in extremity)

이환 중 질병

지병

Comments: Varicose veins in both lower limbs for years without any therapy.

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임상 검사

증상 상세

Intermittent pain over both lower limbs.
Walking and exercise could exaggerate the pain; This regulatory authority case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Intermittent pain over both lower limbs.
Walking and exercise could exaggerate the pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
Varicose veins in both lower limbs for years without any therapy.
On 15-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 18-Mar-2022, the patient experienced PAIN IN EXTREMITY (Intermittent pain over both lower limbs.
Walking and exercise could exaggerate the pain) (seriousness criterion hospitalization).
At the time of the report, PAIN IN EXTREMITY (Intermittent pain over both lower limbs.
Walking and exercise could exaggerate the pain) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
It was reported rest could relieve the patient.
Patient came to CVS OPD for help (15-Mar-2022).
Varicose veins with thrombophlebitis were diagnosis; so, this time, she was admitted (27-Mar-2022) for further evaluation and treatment.
During the hospitalization, 28-Mar-2022 chest pain was noted at night with a relieve of sitting forward and worsened by deep breathing, therefore checking of cardiac enzyme and chest X-ray and EKG were done, the results showed elevated d-dimer and the next day chest CT with contrast, Pulmonary embolism was suspected and therefore adjusted the use of Xalreto from QD to BID use.
The patient was discharged on 31-Mar-2022 under stable condition.
Company Comment: This regulatory case concerns a 74-year-old female patient with a medical history of Varicose veins in both lower limbs for years without any therapy, who experienced the unexpected serious event of Pain in extremity (seriousness criteria hospitalization) after receiving the third dose of mRNA-1273 vaccine.
Its reported that In recent two weeks patient suffered from intermittent pain over both lower limbs.
Which would exaggerate the while walk and exercise and relieved at rest.
Approximately 1 month after the vaccination she went to CVS OPD where they have diagnosed as Varicose veins with thrombophlebitis and was admitted on 27-Mar-2022, During the hospitalization chest pain was noted at night with a relieve of sitting forward and worsened by deep breathing, therefore checked cardiac enzyme and chest X-ray and EKG, the results showed elevated d-dimer and the next day chest CT with contrast, Pulmonary embolism was suspected and therefore adjusted the use of Xalreto from QD to BID use.
The patient was discharged on 31-Mar-2022 under stable condition.
Patients medical history of Varicose veins in both lower limbs could be confounding.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The event was assessed as serious as per Regulatory Authority´s report; Sender's Comments: This regulatory case concerns a 74-year-old female patient with a medical history of Varicose veins in both lower limbs for years without any therapy, who experienced the unexpected serious event of Pain in extremity (seriousness criteria hospitalization) after receiving the third dose of mRNA-1273 vaccine.
Its reported that In recent two weeks patient suffered from intermittent pain over both lower limbs.
Which would exaggerate the while walk and exercise and relieved at rest.
Approximately 1 month after the vaccination she went to CVS OPD where they have diagnosed as Varicose veins with thrombophlebitis and was admitted on 27-Mar-2022, During the hospitalization chest pain was noted at night with a relieve of sitting forward and worsened by deep breathing, therefore checked cardiac enzyme and chest X-ray and EKG, the results showed elevated d-dimer and the next day chest CT with contrast, Pulmonary embolism was suspected and therefore adjusted the use of Xalreto from QD to BID use.
The patient was discharged on 31-Mar-2022 under stable condition.
Patients medical history of Varicose veins in both lower limbs could be confounding.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The event was assessed as serious as per Regulatory Authority´s report.