이상반응 보고
| VAERS ID | 2247516 |
|---|---|
| 성별 | 여성 |
| 나이 | 85세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 1 |
| 접종일 | 2022-02-15 |
| 발병일 | 2022-03-08 |
| 상태 |
증상
- 경정맥 혈전증(Jugular vein thrombosis)
이환 중 질병
Allergy to antibiotic (Keflex); Allergy to antibiotic (Ampicillin); Arrhythmia; Drug allergy (Napoxin); Drug allergy (Demerol); Drug allergy (Celebrex); Hypertension (x 10 years)
지병
Medical History/Concurrent Conditions: Anxiety; Insomnia; Palpitation; Skin rash; Varicose vein
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증상 상세
Left external jugular vein thrombosis; This regulatory authority case was reported by an other health care professional and describes the occurrence of JUGULAR VEIN THROMBOSIS (Left external jugular vein thrombosis) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
The patient's past medical history included Varicose vein, Palpitation, Insomnia, Anxiety and Skin rash.
Concurrent medical conditions included Hypertension (x 10 years), Arrhythmia, Allergy to antibiotic (Ampicillin) since May 2012, Drug allergy (Demerol) since May 2012, Allergy to antibiotic (Keflex) since May 2012, Drug allergy (Celebrex) since March 2018 and Drug allergy (Napoxin) since March 2018.
On 15-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 08-Mar-2022, the patient experienced JUGULAR VEIN THROMBOSIS (Left external jugular vein thrombosis) (seriousness criterion medically significant).
At the time of the report, JUGULAR VEIN THROMBOSIS (Left external jugular vein thrombosis) was resolving.
The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient took NSAID on DEC-2016 as historical drug for unknown indication and she experienced edema.
It is unsure patient was smoking and alcohol drinking.
No concomitant products were reported.
On 08 Mar 2022, patient had Right leg pain, left neck pain with engorged vessel int claudication; bil legs varicose vein; prior dizziness, D-dimer 1805.
On 15 Mar 2022: echo: Thrombotic occlusion of left external jugular vein.
Mild bilateral popliteal vein.
On 21 Mar 2022: OPD.
feels palpitation, and breathless occasionally, left neck swelling resolved after rivaroxaban.
On 22 Mar 2022, March 22: OPD.
swelling over right lower legs 7 days ->3 weeks later neck swelling (IM over left shoulder).
Bilateral knees OA change with varicose and mild effusion over right suprapatellar recess.
CXR revealed anterior superior mediastinum opacity.
02 Apr 2022: The anti-PF4 antibody test sheet was uploaded.
06 Apr 2022: A call was made to care the patient, saying that the swelling and congestion of the left neck had been relatively improved, but the swelling and pain of the right foot still existed.
Company comment: This Regulatory Authority case concerns a 85-year-old, female patient, with medical history of arrhythmia, who experienced the unexpected, serious (Medically significant) AESI of Jugular vein thrombosis, that occurred approximately 21 days after receiving the first dose of mRNA-1273 vaccine.
It was reported that she developed right leg pain, left neck pain, claudication and that D-dimer result was 1805 (no units).
Diagnosis was confirmed by an echo.
Anti PF4 antibody was performed, however, the result was not disclosed.
Evolved with palpitations, dyspnoea occasionally and left neck swelling resolved after Rivaroxaban.
Chest radiography revealed anterior superior mediastinum opacity; however the cause was not informed.
The medical history of arrhythmia remains as a confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This Regulatory Authority case concerns a 85-year-old, female patient, with medical history of arrhythmia, who experienced the unexpected, serious (Medically significant) AESI of Jugular vein thrombosis, that occurred approximately 21 days after receiving the first dose of mRNA-1273 vaccine.
It was reported that she developed right leg pain, left neck pain, claudication and that D-dimer result was 1805 (no units).
Diagnosis was confirmed by an echo.
Anti PF4 antibody was performed, however, the result was not disclosed.
Evolved with palpitations, dyspnoea occasionally and left neck swelling resolved after Rivaroxaban.
Chest radiography revealed anterior superior mediastinum opacity; however the cause was not informed.
The medical history of arrhythmia remains as a confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.