이상반응 보고
| VAERS ID | 1829634 |
|---|---|
| 성별 | 여성 |
| 나이 | 38세 |
| 주 코드 | FR |
| 제약회사 | MODERNA |
| 로트 번호 | 3004219 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-08-26 |
| 발병일 | 2021-09-04 |
| 상태 | 회복 |
증상
- 자기 공명 영상(Magnetic resonance imaging)
- 발작(Seizure)
- 뇌파도(Electroencephalogram)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
이환 중 질병
Pregnancy normal
지병
기타 의료
이전 예방접종
알레르기
임상 검사
Test Name: Electroencephalogram; Result Unstructured Data: No irritative activity; Test Date: 20210904; Test Name: Magnetic resonance imaging; Result Unstructured Data: Native MRI: no parenchymal lesions, no mass effect, no stenosis or obstruction of the intracranial arteries, no arteriovenous malformation, no sign of thrombosis or haemorrhage, no arguments in favour of an ischemic CVA.
증상 상세
Maternal exposure during pregnancy; Seizure; This regulatory authority prospective pregnancy case was reported by a physician and describes the occurrence of SEIZURE (Seizure) in a 38-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no.
3004219) for SARS-CoV-2 immunisation.
The occurrence of additional non-serious events is detailed below.
Concurrent medical conditions included Pregnancy normal since 18-Mar-2021.
On 26-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On 04-Sep-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant).
On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).
On 04-Sep-2021, SEIZURE (Seizure) had resolved.
At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Magnetic resonance imaging: normal (normal) Native MRI: no parenchymal lesions, no mass effect, no stenosis or obstruction of the intracranial arteries, no arteriovenous malformation, no sign of thrombosis or haemorrhage, no arguments in favour of an ischemic CVA.
.
On an unknown date, Electroencephalogram: normal (normal) No irritative activity.
For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SEIZURE (Seizure) to be possibly related.
No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).
No concomitant and treatment medication were provided Patient was pregnant at 23 5/7 weeks of amenorrhoea, in usual good health with an unremarkable pregnancy.
During the night of 04-Sep-2021, that was 9 days post-vaccination, the patient's husband noted that her breathing was noisy, that her eyes were open and rolling back, that her head was in extension with trismus and grinding of the teeth, and that there was a loss of contact.
Loss of consciousness was estimated at approximately 15 minutes.
A post-critical phase was described, with persistence of only a mild headache.
The headache eased spontaneously in under 2 hours.
A tongue bite was seen on the left.
A native MRI of the brain performed on 04-Sep-2021 was normal.
The laboratory work-up of 04-Sep-2021 ruled out electrolytic disorders (Na 137 mmol/l (normal range 135-145 mmol/l)) as well as the presence of an inflammatory syndrome (CRP 3 mg/l (normal range was less than 10 mg/l), white blood cells 11.
1 G/l (normal range 4.
0-10.
0 G/l)).
Liver and thrombocyte tests (Thrombocytes 239 G/l (normal range 150-350 G/l)) in the normal range allowed pre-eclampsia or HELLP syndrome to be ruled out on the opinion of a gynecologist.
A neurological consultation of 04-Sep-2021 concluded in a probable inaugural morphine-induced seizure with no triggering factor (no alcohol, benzodiazepines, febrile state, cranial trauma).
Second vaccination dose was taken on 29-Sep-2021.
CC: This is a regulatory case that reports Maternal exposure during pregnancy and the serious unexpected event of seizures, in a 38 years old female with no relevant medical history reported.
As per maternal age, this pregnancy is a High risk pregnancy.
Seizure occurred 10 days after the first dose of spikevax and was considered related to the product per the reporter's assessment.
The benefit-risk relationship of Spikevax in not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation received on 27-Oct-2021.
with translated medical history, results of test, case narrative mentioning lab results and reporter's comments.
; Reporter's Comments: Evaluation of the possibility of administering the 2nd dose of the vaccine depending on the possibility of an adverse effect; Sender's Comments: This is a regulatory case that reports Maternal exposure during pregnancy and the serious unexpected event of seizures, in a 38 years old female with no relevant medical history reported.
As per maternal age, this pregnancy is a High risk pregnancy.
Seizure occurred 10 days after the first dose of spikevax and was considered related to the product per the reporter's assessment.
The benefit-risk relationship of Spikevax in not affected by this report