이상반응 보고
| VAERS ID | 2247533 |
|---|---|
| 성별 | 남성 |
| 나이 | 48세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-24 |
| 발병일 | 2022-02-05 |
| 상태 | 입원 |
증상
- 회저(Gangrene)
이환 중 질병
Cellulitis of toe (Cellulitis over left 1st, right 1st and 5th toes); Gangrene toe (Right 2nd and 5th toe gangrene change with wound formation); Myofascial pain syndrome (generalized myofascial pain); Polyarthralgia (Polyarthralgia (over knees, shoulders)); Polyarthritis; Smoker (1 PPD for 30 years, not quit yet); Type 2 diabetes mellitus (DM type 2).
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증상 상세
Right toes gangrenouschange; This regulatory authority case was reported by an other health care professional and describes the occurrence of GANGRENE (Right toes gangrenouschange) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
Concurrent medical conditions included Type 2 diabetes mellitus (DM type 2), Smoker (1 PPD for 30 years, not quit yet), Polyarthralgia (Polyarthralgia (over knees, shoulders)) since 15-Aug-2021, Myofascial pain syndrome (generalized myofascial pain) since 15-Aug-2021, Gangrene toe (Right 2nd and 5th toe gangrene change with wound formation), Cellulitis of toe (Cellulitis over left 1st, right 1st and 5th toes) and Polyarthritis.
On 24-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 05-Feb-2022, the patient experienced GANGRENE (Right toes gangrenouschange) (seriousness criterion hospitalization).
At the time of the report, GANGRENE (Right toes gangrenouschange) was resolving.
Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
No concomitant medications were provided.
The age of the patient was reported as 48.
2 years.
12 Mar 2022 patient suffered from polyarthritis for months over bilateral shoulders, elbows and knees, no finger joint pain, and was admitted to hospital during 01 Mar to 11 Mar due to cellulitis over left first, right first and fifth toes.
During his hospitalization CT on 01 Mar showed small, calcified plaques in aorta and bilateral common iliac arteries, but no definite filling defect in bil.
lower limbs arteries.
Debridement was performed on 01 Mar.
After debridement, right second and fifth toe became dry gangrene, but cyanosis did not improve after treatment.
Patient was discharged on 11 Mar under stable condition.
After discharge, patient went to ER.
Upon arrival, physical examination showed intact pulse over bil.
dorsalis pedis, redness over right mid foot.
Lab revealed no leukocytosis, normal CRP & PCT, elevated Lactate.
Under the impression of dry gangrene of bil lower limbs, rule out PAOD, rule out vasculitis, status post Promostan (3/12-), Oxacillin(3/12-), patient was admitted for further treatment.
After admission, they kept wound care for patient dry gangrene over bilateral lower limbs.
Oxacillin was administered due to erythematous swelling and local heat was noted.
CV specialist was consulted for rule out PAOD.
PTA for right leg was done on March 24 and right ATA to DPA CTO was noted, status post POBA.
Under the impression of Buerger's disease, they kept anti platelet and anticoagulant with Bokey, Pletal, Rivaroxaban and Enoxaparin after PTA.
Also, self paid Viagra was added for vasodilation.
Due to suspicious tarry stool, Enoxaparin was discontinued since April 3.
Stool occult blood was negative.
Swelling and local heat over bilateral lower limbs subsided gradually.
Education for wound care was done.
Under relatively stable condition, patient was discharged.
This regulatory authority case concerns a 48-year-old male patient, with medical history of Type 2 diabetes mellitus and Smoker (1 PPD for 30 years), who experienced the unexpected serious (hospitalized) event of GANGRENE, which occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine.
Patient suffered from polyarthritis for months over bilateral shoulders, elbows and knees, no finger joint pain, and was admitted to hospital due to cellulitis over left first, right first and fifth toes.
Computerized Tomography showed small, calcified plaques in aorta and bilateral common iliac arteries, but no definite filling defect in bil.
lower limbs arteries.
Debridement was performed.
After debridement, right second and fifth toe became dry gangrene, but cyanosis did not improve.
Patient was discharged under stable condition, but patient returned to ER.
Physical examination showed intact pulse over bil.
dorsalis pedis, redness over right mid foot.
Under the impression of dry gangrene of bil lower limbs, (PAOD and vasculitis ruled out) patient was admitted for further treatment.
Oxacillin was administered.
Under the impression of Buerger's disease, they kept anti platelet and anticoagulant with Bokey, Pletal, Rivaroxaban and Enoxaparin after PTA.
Viagra was added for vasodilation.
Due to suspicious tarry stool, Enoxaparin was discontinued.
Stool occult blood was negative.
Swelling and local heat over bilateral lower limbs subsided gradually.
Education for wound care was done.
Under relatively stable condition, patient was discharged .
The mentioned medical history 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 48-year-old male patient, with medical history of Type 2 diabetes mellitus and Smoker (1 PPD for 30 years), who experienced the unexpected serious (hospitalized) event of GANGRENE, which occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine.
Patient suffered from polyarthritis for months over bilateral shoulders, elbows and knees, no finger joint pain, and was admitted to hospital due to cellulitis over left first, right first and fifth toes.
Computerized Tomography showed small, calcified plaques in aorta and bilateral common iliac arteries, but no definite filling defect in bil.
lower limbs arteries.
Debridement was performed.
After debridement, right second and fifth toe became dry gangrene, but cyanosis did not improve.
Patient was discharged under stable condition, but patient returned to ER.
Physical examination showed intact pulse over bil.
dorsalis pedis, redness over right mid foot.
Under the impression of dry gangrene of bil lower limbs, (PAOD and vasculitis ruled out) patient was admitted for further treatment.
Oxacillin was administered.
Under the impression of Buerger's disease, they kept anti platelet and anticoagulant with Bokey, Pletal, Rivaroxaban and Enoxaparin after PTA.
Viagra was added for vasodilation.
Due to suspicious tarry stool, Enoxaparin was discontinued.
Stool occult blood was negative.
Swelling and local heat over bilateral lower limbs subsided gradually.
Education for wound care was done.
Under relatively stable condition, patient was discharged with IMRH/META/CV OPD.
The mentioned medical history remains as a confounder.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.