이상반응 보고
| VAERS ID | 2247521 |
|---|---|
| 성별 | 남성 |
| 나이 | 49세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | |
| 예방접종 횟수 | 3 |
| 접종일 | 2022-04-04 |
| 발병일 | 2022-04-06 |
| 상태 | 중증 |
증상
- 과민증(Hypersensitivity)
이환 중 질병
Hypertension
지병
기타 의료
이전 예방접종
알레르기
임상 검사
증상 상세
Severe Allergic reaction; This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Severe Allergic reaction) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
Concurrent medical conditions included Hypertension.
On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 06-Apr-2022, the patient experienced HYPERSENSITIVITY (Severe Allergic reaction) (seriousness criterion life threatening).
At the time of the report, HYPERSENSITIVITY (Severe Allergic reaction) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Concomitant product use was not provided by the reporter.
Patient received BNT vaccine on 19-Oct-2021 and 27-Nov-2021.
No wheezing, swelling neck, no skin rash.
Patient received Moderna vaccine on 04-Apr-2022.
On 06-Apr-2022 the patient experienced sudden tongue and neck swelling since 02:00.
No stridor mega tongue couldn't talk.
0.
3-amp bosmin 2 was administered in another hospital.
Date Time Systolic blood pressure Diastolic blood pressure Pulse Respiration Body temperature SpO2 GCS 06-Apr-2022 5:10 179 94 101 20 35.
7 98 15 06-Apr-2022 5:17 158 86 97 23 98 15 06-Apr-2022 5:58 160 85 129 25 98 15 06-Apr-2022 6:07 174 89 136 17 100 15 06-Apr-2022 6:50 164 92 122 17 100 15 06-Apr-2022 8:07 176 91 99 11 37.
1 100 15 06-Apr-2022 9:03 165 93 99 18 100 15 06-Apr-2022 10:08 170 92 98 18 100 15.
On 07-Apr-2022: Consulted the reporting hospital and left the phone number of spouse/miss Dai and the patient.
The patient had On Endo due to tongue swelling in the emergency department, which has been removed and the patient was still in hospital.
The relief for harm has been explained.
As the organization and address of the patient were in another county and city, the case would be systematically returned.
Company comment: This regulatory case concerns a 49-year-old, male patient with no reported relevant medical history, who experienced the life-threatening, unexpected event of Hypersensitivity.
The patient also received Tozinameran as primary COVID-19 vaccine series approximately 5 months prior to mRNA-1273.
The event occurred 2 days after receiving mRNA-1273 as third dose of COVID-19 vaccine, initially presenting with swelling of the tongue and neck.
The patient was brought to a hospital where he was immediately given Epinephrine (Bosmin).
He was then transferred to another institution with admitting vital signs of elevated blood pressure (179/94), mildly increased heart rate (101), low temperature (35.
7) but with normal respiration.
Endotracheal intubation was performed due to tongue swelling, to secure the airway.
Serial vital signs monitoring was done thereafter with note of normal heart and respiratory rates and eventual normalization of temperature, although still with high blood pressure.
The intubation was subsequently removed a day after admission.
Treatment medications given in the second hospital was not provided in the case.
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 49-year-old, male patient with no reported relevant medical history, who experienced the life-threatening, unexpected event of Hypersensitivity.
The patient also received Tozinameran as primary COVID-19 vaccine series approximately 5 months prior to mRNA-1273.
The event occurred 2 days after receiving mRNA-1273 as third dose of COVID-19 vaccine, initially presenting with swelling of the tongue and neck.
The patient was brought to a hospital where he was immediately given Epinephrine (Bosmin).
He was then transferred to another institution with admitting vital signs of elevated blood pressure (179/94), mildly increased heart rate (101), low temperature (35.
7) but with normal respiration.
Endotracheal intubation was performed due to tongue swelling, to secure the airway.
Serial vital signs monitoring was done thereafter with note of normal heart and respiratory rates and eventual normalization of temperature, although still with high blood pressure.
The intubation was subsequently removed a day after admission.
Treatment medications given in the second hospital was not provided in the case.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness was assessed as per Regulatory Authority's report.