이상반응 보고
| VAERS ID | 1853330 |
|---|---|
| 성별 | 여성 |
| 나이 | 38세 |
| 주 코드 | NY |
| 제약회사 | PFIZER\BIONTECH |
| 로트 번호 | EN5318 |
| 예방접종 횟수 | 1 |
| 접종일 | 2021-02-12 |
| 발병일 | 2021-02-12 |
| 상태 | 회복 |
증상
- 예방 접종 부위 통증(Vaccination site pain)
- 임신 중 모성 노출(Maternal exposure during pregnancy)
이환 중 질병
지병
Medical History/Concurrent Conditions: Live birth; Miscarriage; Seasonal asthma
기타 의료
PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ASPIRIN [ACETYLSALICYLIC ACID]
이전 예방접종
알레르기
임상 검사
증상 상세
injection site pain; scheduled to get my 2nd dose of the Pfizer Covid vaccine today, I am currently 19 weeks pregnant; This is a spontaneous report from a contactable pharmacist (patient).
This is a maternal report.
A 38-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in deltoid on 12Feb2021 afternoon (at the age of 38-year-old) as dose 1, single for COVID-19 immunization.
Medical history included seasonal asthma, obstetrical history included 3 previous pregnancies and 1 other child.
She had 2 miscarriages/2 live births (one of the live births was preterm).
Concomitant medications included Prenatal vitamins (capsules) for pregnancy at the frequency of once a day, orally from Dec2020 and ongoing and acetylsalicylic acid (ASPIRIN) 81mg tablet taken for pregnancy from Dec2020 to Jul2021.
The patient had no prior vaccination.
The patient was pregnant at the time of vaccination.
The last menstrual period date was on an unknown date Oct2020 and estimated date of conception was in Nov2020.
On 12Feb2021, the patient experienced injection site pain.
The mother reported she became pregnant while taking bnt162b2.
The mother was 19 Weeks pregnant at the onset of the event.
The mother was not smoking, drink alcohol or used illicit drugs during pregnancy.
The mother delivered the pregnancy via cesarean delivery.
The baby was delivered full-term.
Gestational age at birth was 39 weeks 4 days.
The baby weighed 2721grams.
APGAR Score 1 was 9, APGAR Score 2 was not provided, APGAR Score 3 was not provided.
The fetal outcome is normal.
Neonatal Information- Infant Details: Gender: Female Weight at birth: 6 lbs 7 oz Length at birth: 19 in Head circumstance at birth: 34cm.
The patient did not have any problem before delivery and during delivery (including delivery complications, fetal distress, amniotic fluid abnormal, abnormal placenta).
After delivery she had high total bilirubin.
No treatment was received by the patient for the event.
The outcome of the injection site pain was recovered on an unknown date in 2021.
Follow-up attempts are completed.
No further information is expected.
Follow-up (27Aug2021 and 14Sep2021): This is a follow up-spontaneous report from a contactable Pharmacist (patient).
This Pharmacist (patient) reported in response to HCP letter via follow-up letter which included that: Age at vaccination, dose 1 details (date of vaccination, lot/batch no, dosing details), new events (injection site pain and maternal exposure during pregnancy, second trimester), medical history, pregnancy details and other clinically relevant information added and updated in narrative accordingly.