Sex: F
Vaccine: COVID19
Symptoms: Foetal distress syndrome, Maternal exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Maternal exposure during pregnancy; Fetal Distress; This is a spontaneous report from a contactable consumer (parent). A female fetus received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EH9899) via transplacental on 02Jan2021 (gestational period at time of initial exposure: 02 months, 1st trimester) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL3248) via transplacental on 23Jan2021 (gestational period at time of initial exposure: 02 months, 1st trimester), both as a single dose for COVID-19 immunization. Medical history was not reported. Maternal medical history included diabetes mellitus type 2, PCOS, depression, cholesterol and GERD. The mother had two previous pregnancies and the outcome of previous pregnancies was miscarriage. The mother did not smoke, drunk alcohol or use illicit drugs during the pregnancy. The mother did not have any treatment for infertility. First day of last menstrual period was reported as 25Oct2020. Estimated date of conception was reported as 10Nov2021. Estimated delivery date was reported as 01Aug2021. Paternal relevant history was reported as environmental allergies. The father did not smoke, drink alcohol or use illicit drugs during the mother's pregnancy. Paternal exposure to products was reported as: multivitamin (Centrum men's), 1 tab daily; mesalamine ER for IBS, 4 tab in AM; Zyrtec for allergy, 1 tab daily; symista for allergy, 2 sprays daily and hyosayamine for IBS, 0.125mg 3-4 times daily, start date for all was reported as prior. Concomitant medications included escitalopram oxalate (LEXAPRO) via transplacental taken for depression on unspecified dates at 20mg, daily; acetylsalicylic acid (ASPIRIN BAYER) via transplacental take to prevent preeclampsia from 12Jan2020 to an unspecified date at 81 mg, daily; minerals NOS/vitamins NOS (PRENATAL VITAMINS; tablet) via transplacental for pregnancy from 12Jan2020 to an unspecified date at 1 DF, daily; insulin glargine (LANTUS) via transplacental taken for type 2 DM (diabetes mellitus) from 02Jan2020 to 09Aug2021 at 12-24 units bedtime; fish oil (FISH OIL OMEGA 3; tablet) via transplacental taken for cholesterol on unspecified dates at 2 DF, daily and famotidine (PEPCID AC) via transplacental taken for GERD on unspecified dates at 20 mg, daily. On 27Jul2021, that patient experienced fetal distress and on an unspecified date the patient experienced maternal exposure during pregnancy. The outcome of the pregnancy was reported as full term live birth. Date of outcome of pregnancy was reported as 27Jul2021. Gestation age at birth in weeks was 39 weeks. The outcome of infant was reported as normal newborn; Apgar Score: 1min 1; 5min 7. Malformation/anomalies diagnosed were none. Developmental assessment was normal-47th percentile. The patient underwent ultrasounds on 11Dec2020, 02Mar2021, 13Apr2021, 07May2021, 11May2021, 08Jun2021, 15Jun2021, 22Jun2021, 29Jun2021, 06Jul2021, 15Jul2021 and 20Jul2021, all with unknown results. The clinical outcome of the events fetal distress and maternal exposure during pregnancy were unknown.