이상반응 보고
| VAERS ID | 2178440 |
|---|---|
| 성별 | 여성 |
| 나이 | |
| 주 코드 | FR |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | FF0688 |
| 예방접종 횟수 | 2 |
| 접종일 | 2021-07-30 |
| 발병일 | 2021-07-30 |
| 상태 | 중증 회복 |
증상
- 고혈압(Hypertension)
- 초음파 스캔(Ultrasound scan)
- 혈액 젖산 탈수소효소(Blood lactate dehydrogenase)
- 혈압 측정(Blood pressure measurement)
- 혈소판 수(Platelet count)
- 우울증(Depression)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
- 알라닌 아미노전이효소(Alanine aminotransferase)
- 아스파르테이트 아미노전이효소(Aspartate aminotransferase)
- 단백질 소변(Protein urine)
- 태반 장애(Placental disorder)
- 전자간증(Pre-eclampsia)
- 헬프 증후군(HELLP syndrome)
- 심리적 외상(Psychological trauma)
- 간 세포 용해(Hepatic cytolysis)
이환 중 질병
Gestational diabetes (on insulin therapy); HLA-B*27 positive; Obesity (Grade 1 (BMI 34.5))
지병
Medical History/Concurrent Conditions: Polycystic ovarian syndrome; Pregnancy (first pregnancy without pre-eclampsia and hypertension; vaginal delivery, resulting from IVF); Psoriasis
기타 의료
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임상 검사
Test Date: 20210826; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:197 IU/l; Test Date: 20210826; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:171 IU/l; Test Date: 20210826; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:247; Test Name: Residual hypertension; Result Unstructured Data: Test Result:141/86 mmHg; Comments: mean arterial pressure after ambulatory blood pressure monitoring; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:160/90 mmHg; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:180/100 mmHg; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:170/90 mmHg; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:150/90 mmHg; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:149/90 mmHg; Comments: on her arrival; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:150/90 mmHg; Comments: in the delivery room; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:149/90 mmHg; Comments: in the delivery room; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:169/99 mmHg; Comments: in the delivery room; Test Date: 20210826; Test Name: Residual hypertension; Result Unstructured Data: Test Result:150/100 mmHg; Comments: in the delivery room; Test Date: 20210826; Test Name: Platelet count; Result Unstructured Data: Test Result:139.
000 /mm3; Comments: normal crasis; Test Name: Urine protein test; Test Result: 0.
32 g; Comments: positive vascular-renal assessment (otherwise normal) and positive 24-hour proteinuria - 0.
32 g/24 hours; Test Date: 20210817; Test Name: Control ultrasound; Result Unstructured Data: Test Result:intrauterine growth retardation; Test Date: 20210826; Test Name: Control ultrasound; Result Unstructured Data: Test Result:good fetal vitality, no image of detachment; Test Date: 20210826; Test Name: Control ultrasound; Result Unstructured Data: Test Result:fetal weight of 460 grams; Comments: with reverse flow umbilical Doppler, below the 1st percentile, biological assessment shows the beginning of a HELP syndrome with hepatic cytolysis
증상 상세
hepatic cytolysis; Residual hypertension; Psychological trauma; Depression; Unremarkable placenta (poor maternal vascularization); HELLP syndrome; Pre-eclampsia; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority.
The reporter is the patient.
Regulatory number: FR-AFSSAPS-ST20220703.
A 30 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 30Jul2021 (Lot number: FF0688) as dose 2, 30 ug single for covid-19 immunisation.
Relevant medical history included: "Polycystic ovary syndrome" (unknown if ongoing); "Obesity" (ongoing), notes: Grade 1 (BMI 34.
5); "Gestational diabetes" (ongoing), notes: on insulin therapy; "HLA-B*27 positive" (ongoing); "Psoriasis" (unspecified if ongoing); "Pregnancy" (unspecified if ongoing), notes: first pregnancy without pre-eclampsia and hypertension; vaginal delivery, resulting from IVF.
The patient was 20 weeks pregnant at the event onset.
The patient's concomitant medications were not reported.
Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), administration date: 09Jul2021, for COVID-19 vaccination.
The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (life threatening) with onset 30Jul2021, outcome "unknown", described as "Maternal Exposure During Pregnancy, second trimester"; HELLP SYNDROME (life threatening) with onset 25Aug2021, outcome "recovered", described as "HELLP syndrome"; PRE-ECLAMPSIA (life threatening) with onset 25Aug2021, outcome "recovered", described as "Pre-eclampsia"; HEPATIC CYTOLYSIS (medically significant), outcome "unknown", described as "hepatic cytolysis"; HYPERTENSION (non-serious), outcome "unknown", described as "Residual hypertension"; PSYCHOLOGICAL TRAUMA (non-serious), outcome "unknown", described as "Psychological trauma"; DEPRESSION (non-serious), outcome "unknown", described as "Depression"; PLACENTAL DISORDER (non-serious), outcome "unknown", described as "Unremarkable placenta (poor maternal vascularization)".
Second dose injected at 20th week of pregnancy + 3 days.
18 days later after this second dose, second trimester control ultrasound showing intrauterine growth retardation (17Aug2021).
On 25Aug2021, severe pre-eclampsia with HELP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome.
Implementation of intravenous hypotensive treatments.
Medical Termination of Pregnancy with the birth of lifeless daughter on 26Aug2021 at 24th week of pregnancy and 2 days.
No high blood pressure before this pregnancy.
First pregnancy without pre-eclampsia and hypertension.
Completed.
Post pre-eclampsia assessment finding no explanation for this complication.
Unremarkable placenta (poor maternal vascularization).
No change in maternal blood samples (thrombotic, antibodies etc.
normal).
Residual hypertension (after ambulatory blood pressure monitoring: mean arterial pressure 141/86 mm Hg).
Psychological trauma.
Depression.
Work stoppage for more than 6 months.
Residual hypertension.
Date of fertilization retained: 23Mar2021, end of pregnancy retained: 21Dec2021.
Pregnancy obtained spontaneously.
Growth at the 4th percentile (National college of gynecologists and obstetricians), 16th (Research team in perinatal and pediatric obstetrical epidemiology) on 17Aug2021.
Implementation of blood pressure self-monitoring at home since 23Aug2021 in the face of the discovery of blood pressure limits in consultation; performance of a vascular-renal assessment (BVR) and a 24-hour proteinuria that came back positive at 0.
32 g/24 hours.
The BVR was otherwise normal.
Growth ultrasound is scheduled for 30Aug2021.
On the night of 26Aug2021, the patient was awakened by severe epigastric pain leading her to call the medical emergency.
When the medical emergency arrives, the blood pressure cycle is as follows: 160/90, 180/100, 170/90, 150/90, 149/90 mmHg, treatment with Loxen intravenously and magnesium sulphate is undertaken.
On her arrival, the patient was hypertensive at 149/90 mmHg on magnesium sulphate alone, suspension of Loxen during the stay without functional signs of hypertension.
Improvement of headaches and epigastric pain.
No functional signs of hypertension.
The osteotendinous reflexes are normal.
On ultrasound there is good fetal vitality, no image of detachment.
Ultrasound performed in the emergency room found an estimated fetal weight of 460 grams with reverse flow umbilical Doppler, below the 1st percentile.
The biological assessment shows the beginning of a HELP syndrome with hepatic cytolysis, normal crasis.
It was decided at a department meeting to perform a medical termination of pregnancy for maternal safeguard in a context of severe preeclampsia with beginning HELP syndrome.
The events "hellp syndrome" and "pre-eclampsia" were evaluated at the emergency room visit.
The pregnancy resulted in therapeutic abortion.
The patient underwent the following laboratory tests and procedures: alanine aminotransferase: (26Aug2021) 197 IU/l; aspartate aminotransferase: (26Aug2021) 171 IU/l; blood lactate dehydrogenase: (26Aug2021) 247; blood pressure measurement: (unspecified date) 141/86 mmHg, notes: mean arterial pressure after ambulatory blood pressure monitoring; (26Aug2021) 160/90 mmHg; (26Aug2021) 180/100 mmHg; (26Aug2021) 170/90 mmHg; (26Aug2021) 150/90 mmHg; (26Aug2021) 149/90 mmHg, notes: on her arrival; (26Aug2021) 150/90 mmHg, notes: in the delivery room; (26Aug2021) 149/90 mmHg, notes: in the delivery room; (26Aug2021) 169/99 mmHg, notes: in the delivery room; (26Aug2021) 150/100 mmHg, notes: in the delivery room; platelet count: (26Aug2021) 139.
000 /mm3, notes: normal crasis; protein urine: (unspecified date) 0.
32 g, notes: positive vascular-renal assessment (otherwise normal) and positive 24-hour proteinuria - 0.
32 g/24 hours; ultrasound scan: (17Aug2021) intrauterine growth retardation; (26Aug2021) good fetal vitality, no image of detachment; (26Aug2021) fetal weight of 460 grams, notes: with reverse flow umbilical Doppler, below the 1st percentile, biological assessment shows the beginning of a HELP syndrome with hepatic cytolysis.
Therapeutic measures were taken as a result of hellp syndrome, pre-eclampsia, hypertension.
No follow-up attempts are possible.
No further information is expected.
; Sender's Comments: Linked Report(s) : FR-PFIZER INC-202200401470 mother/fetus case