이상반응 보고

VAERS ID	2247515
성별	여성
나이	40세
주 코드	FR
제약회사	MODERNA
로트 번호
예방접종 횟수	3
접종일	2022-03-07
발병일	2022-04-02
상태	입원

증상

• 심 부정맥 혈전증(Deep vein thrombosis)

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임상 검사

증상 상세

Deep vein thrombosis; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
No Medical History information was reported.
On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 02-Apr-2022, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion hospitalization).
At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) had resolved with sequelae.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Other relevant information related to past history of diseases, smoking, alcohol drinking, and allergy was not reported.
Patient received BNT vaccine on 24-Oct-2021 and 28-Nov-2021.
Patient received Moderna vaccine on 07-Mar-2022.
According to patient's statement, she took contraceptive pill since this year, just stopped 3 days ago.
She suffered from left limb swelling for one day (27-Mar).
She felt progressive leg swelling accompanied with pain and numbness.
So she was brought to the emergency department where bedside echo showed left popliteal vein thrombus with poor compressibility.
Throughout the whole course, there was no fever, chills, dyspnea, cough, chest pain, abdominal pain, trauma history nor wound.
The patient was under the impression of deep venous thrombosis.
She was admitted to the ward for further survey and treatment since 28-Mar.
Rheumatology and Immunology: Tentative diagnosis: left leg DVT, r/o APS due to abortion history.
On 07-Apr-2022, follow-up outcome stated headache, diarrhea and thrombosis in the lower leg occurred for many days after vaccination.
The symptoms had been recovered and had been informed of the relief for drug harm.
CC: This is a Regulatory Authority case concerning a 40-year-old female patient, with no medical history reported in this case, previously vaccinated with BNT vaccine and user of contraceptive pill (stopped in an unknown date), who experienced the serious unexpected AESI of Deep vein thrombosis that leads to hospitalization, approximately 27 days after the administration of the 3rd dose of the mRNA-1273 vaccine.
The reported use of contraceptive pills recently, remains as a contributor for the event.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Event´s seriousness assessed as reported.
; Sender's Comments: This is a Regulatory Authority case concerning a 40-year-old female patient, with no medical history reported in this case, previously vaccinated with BNT vaccine and user of contraceptive pill (stopped in an unknown date), who experienced the serious unexpected AESI of Deep vein thrombosis that leads to hospitalization, approximately 27 days after the administration of the 3rd dose of the mRNA-1273 vaccine.
The reported use of contraceptive pills recently, remains as a contributor for the event.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Event´s seriousness assessed as reported.