이상반응 보고
| VAERS ID | 2247494 |
|---|---|
| 성별 | 여성 |
| 나이 | 55세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 2100686_1110418 |
| 예방접종 횟수 | 3 |
| 접종일 | 2022-03-25 |
| 발병일 | 2022-03-28 |
| 상태 | 사망 |
증상
- 근육 약화(Muscular weakness)
- 혈소판 감소증(Thrombocytopenia)
- 변경된 의식 상태(Altered state of consciousness)
- 반상 출혈(Ecchymosis)
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Thrombocytopenia; Right eye ecchymosis with swelling, and left tongue with ecchymosis spot; Change of consciousness; Limb weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia), ECCHYMOSIS (Right eye ecchymosis with swelling, and left tongue with ecchymosis spot), ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) and MUSCULAR WEAKNESS (Limb weakness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
2100686_1110418-CDC) for COVID-19 vaccination.
No Medical History information was reported.
On 25-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.
On 28-Mar-2022, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion death), ECCHYMOSIS (Right eye ecchymosis with swelling, and left tongue with ecchymosis spot) (seriousness criterion death), ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) (seriousness criterion death) and MUSCULAR WEAKNESS (Limb weakness) (seriousness criterion death).
It is unknown if an autopsy was performed.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No concomitant medications were reported.
The patient suffered from conscious change, coffee-ground vomitus and tarry stool were noted for 1 day and went to ER.
The patient had been vaccinated with COVID-19 vaccine (BNT) twice on 15-Oct-2021 and 19-Nov-2021; (Moderna) on 25-Mar-2022, after injection the patient complained about headache and dizziness and went to clinic for help.
The patient was treated with medicine but was in vain.
On 28-Mar-2022, in infectious OPD, chief complaint was right eye ecchymosis with swelling for 3 days after Moderna injection, small ecchymosis over left tongue, denied traumatic history before.
Due to leukocytosis, thrombocytopenia and coagulopathy, suspected vaccine related leukemia, suggested transfer to hematology OPD for further survey.
After hematology doctor evaluated, thrombocytopenia and leukocytosis were found, was suspicious for acute leukemia, thrombosis with thrombocytopenia syndrome.
However, progressive nausea, vomitus and conscious loss were also noted, Patient's GCS was E1V1M1, pupil size R/L 6.
0 mm/6.
0 mm with nonreactive to light, T/P/R were 36.
8/89/20, BP was 219/128 mmHg at ER.
Physical examination of right eye showed ecchymosis.
Chest x-ray disclosed no significant fracture and pneumonia patch.
Brain CT revealed bilateral ICH, IVH, Right occipitoparietal and left occipital cerebral hematoma with local cerebral edema, Small right frontal epidural hematoma, Left posterior cerebellar hemispheric cortical hematoma, SAH in the interhemispheric fissures, Subfalcine herniation to left, Bilateral uncal herniation compressing brain stem.
NS was consulted and anti-epileptics, osmotic diuretic, Vit.
K1 and Transamin injection was done.
After treatment and examination, then she was admitted to NSICU for further management.
On 30-Mar-2022, the patient was in the intensive care unit, the fever had been reduced.
Due to poor coagulation function, no operation was carried out for treatment.
Drug treatment was given.
Company Comment: This regulatory case concerns a 55-year-old female patient, with no reported medical history, who experienced the unexpected serious fatal events of Thrombocytopenia (AESI), Ecchymosis (AESI), Altered state of consciousness, and Muscular weakness that occurred 3 days after receiving the mRNA-1273 vaccine as a 3rd dose.
On the day after vaccination, the patient had headache and dizziness, and sought consult but no improvement despite medication given.
Later, patient noted right eye ecchymosis with swelling, and left tongue with ecchymosis spot.
OPD consult with hematologist done and evaluated as thrombocytopenia, leukocytosis, suspicious for acute leukemia, and thrombosis with thrombocytopenia syndrome.
Patient's condition progressed and was rushed to the ER due to progressive nausea, coffee-ground vomitus, tarry stool, and loss of consciousness.
Physical examination showed GCS was E1V1M1, pupil size R/L 6.
0 mm/6.
0 mm, nonreactive, Temp 36.
8, Pulse 89, Respiration 20 (units not reported), BP was 219/128 mmHg, and right eye ecchymosis.
Chest x-ray disclosed no significant fracture and pneumonia patch.
Brain CT revealed the following results: Bilateral ICH, IVH.
Right occipitoparietal and left occipital cerebral hematoma with local cerebral edema.
Small right frontal epidural hematoma.
Left posterior cerebellar hemispheric cortical hematoma.
SAH in the interhemispheric fissures.
Subfalcine herniation to left.
Bilateral uncal herniation compressing brain stem.
Patient started with anti-epileptic, osmotic diuretic, vitamin K1 and Transamin injection, with closed monitoring in NSICU.
Eventually patient died 8 days from events onset and 11 days post vaccination.
Patient had previously received 2 doses of COVID-19 vaccine (BNT) with the 2nd dose received 4months and 9 days prior to events onset.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness was assessed as per Regulatory Authority's report.
; Sender's Comments: This regulatory case concerns a 55-year-old female patient, with no reported medical history, who experienced the unexpected serious fatal events of Thrombocytopenia (AESI), Ecchymosis (AESI), Altered state of consciousness, and Muscular weakness that occurred 3 days after receiving the mRNA-1273 vaccine as a 3rd dose.
On the day after vaccination, the patient had headache and dizziness, and sought consult but no improvement despite medication given.
Later, patient noted right eye ecchymosis with swelling, and left tongue with ecchymosis spot.
OPD consult with hematologist done and evaluated as thrombocytopenia, leukocytosis, suspicious for acute leukemia, and thrombosis with thrombocytopenia syndrome.
Patient's condition progressed and was rushed to the ER due to progressive nausea, coffee-ground vomitus, tarry stool, and loss of consciousness.
Physical examination showed GCS was E1V1M1, pupil size R/L 6.
0 mm/6.
0 mm, nonreactive, Temp 36.
8, Pulse 89, Respiration 20 (units not reported), BP was 219/128 mmHg, and right eye ecchymosis.
Chest x-ray disclosed no significant fracture and pneumonia patch.
Brain CT revealed the following results: Bilateral ICH, IVH.
Right occipitoparietal and left occipital cerebral hematoma with local cerebral edema.
Small right frontal epidural hematoma.
Left posterior cerebellar hemispheric cortical hematoma.
SAH in the interhemispheric fissures.
Subfalcine herniation to left.
Bilateral uncal herniation compressing brain stem.
Patient started with anti-epileptic, osmotic diuretic, vitamin K1 and Transamin injection, with closed monitoring in NSICU.
Eventually patient died 8 days from events onset and 11 days post vaccination.
Patient had previously received 2 doses of COVID-19 vaccine (BNT) with the 2nd dose received 4months and 9 days prior to events onset.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness was assessed as per Regulatory Authority's report.