Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis viral test, Investigation, Maternal exposure during pregnancy, Placenta praevia haemorrhage, Rubella antibody test
Clinical narrative: I am currently 14 weeks pregnant and received the Pfizer vaccine at 7 weeks and 10 weeks pregnant.; Placenta previa with bleeding/hemorrage; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old age of pregnant female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number: EK9231, batch no/Expiration date: not reported) via intramuscular route of administration in Arm Left on 03Jan2021 (at the age of 33-years-old) as dose 1, single and BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number: EL3247, batch no/Expiration date: not reported) via intramuscular route of administration in Arm Left on 24Jan2021 (at the age of 33-years-old) as dose 2, single both for covid-19 immunization at Workplace Clinic. Medical history includes Covid-19 from 22Aug2020 to an unknown date. Prenatal care from unknown date and previous pregnancy for child 1 with live birth preterm. Concomitant medications include folic acid (FOLATE) for Prenatal care, acetaminophen taken for pain and multivitamins taken for prenatal care. No prior vaccinations within 4 weeks. It was reported she was wondering if there was any/ will be retroactive studies surrounding the Pfizer vaccine in pregnancy. Patient was currently 14 weeks pregnant and received both doses of the Pfizer vaccine at 7 weeks and 10 weeks pregnant. Last menstrual period was 12Nov2020. Estimated date of conception was 23Nov2020 and estimated date of delivery was 19Aug2021. Gestational period at time of initial exposure was 2 months, 1st Trimester. Mother did not smoke and did not drink alcohol, did not used illicit drugs during this pregnancy. Obstetrical History included previous pregnancies as 1 child with Live birth - preterm (35 weeks, 3 days). Paternal Information included as no Recreational Drug Use and father did not smoke during the mother's pregnancy and drink alcohol during the mother's pregnancy as Rare, less than 1 month. Did not use illicit drugs during the mother's pregnancy. The mother delivered the pregnancy on 31Jul2021. The patient experienced placenta previa with bleeding/hemorrhage on 01May2021. Patient underwent lab tests and procedures as on an unknown date for serology tests, Hep B with results non-reactive, Rubella antibody as reactive, Toxo (Toxicologic test) with unknown results. On 22Aug2020, Patient tested positive for Sars-Cov-2 test for covid-19, on 25Feb2021, Ultrasound tests with unknown results, on 11Mar2021 serum markers with unknown results and next ultrasound was on 29Mar2021 scheduled.   Information on the lot/batch number has been requested.  Follow-up (24Mar2021): This is a follow-up spontaneous report from a contactable Nurse. This 33-year-old Nurse reported in response to Non-HCP letter sent via email which included that: new information of reporter, age, Con-meds, suspect dose details, lot number, RMH, Lab data and clinical information.  Follow-up (07Sep2021): New information from the same contactable nurse (patient) included: Patient details (Relevant medical history and lab data captured), Event details (new event added).; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of event placenta praevia haemorrhage cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.