Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Body temperature, Maternal exposure during pregnancy, Placenta praevia, Pyrexia
Clinical narrative: PLACENTA PREVIA; FEVER 99.9 FAHRENHEIT (°F); MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 32 year old female. The patient was enrolled in a non-company sponsored study: (Privacy). The patient's weight was 94.331 kilograms, and height was 175 centimeters. The patient's past medical history included: elective abortion (two past pregnancies), and concurrent conditions included: multigravida (two past pregnancies), alcohol use (once per week during the first three months of pregnancy), single umbilical artery (two vessel umbilical cord), body mass index increased, and no tobacco or recreational drug use, and other pre-existing medical conditions included: The patient's medical history included two vessel umbilical cord. Patient's obstetrical history included two previous pregnancies, both resulting in an elective termination. Patient gravida was 3 and para was 1. The first day of the last menstrual period (LMP) was reported to be 23-APR-2021. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAY-2021 (at gestational age three weeks and five days) for covid-19 immunisation. The patient was pregnant at time of vaccination. Type of pregnancy was reported as singleton. Concomitant medications included calcium carbonate, docosahexaenoic acid, and magnesium oxide. On 19-MAY-2021, the patient experienced maternal exposure during pregnancy. On 20-MAY-2021, the patient experienced fever 99.9 fahrenheit. On 08-AUG-2021, the patient was diagnosed with placenta previa. On 16-SEP-2021, Laboratory data included: Ultrasound foetal (NR: not provided) Not reported. On (Privacy), at gestational age 39 weeks and five days, the patient delivered a live, male, full-term neonate via caesarean method of delivery (C-section). The estimated delivery date (EDD) was calculated to be 28-JAN-2022. Primary reason for C-section was reported to be baby's breech presentation. The patient spent five days in the hospital for the delivery. The neonate's birth weight was 8 pounds, body length 20 inches. The neonate was admitted in the Neonatal Intensive Care Unit (NICU) due to jaundice. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 30.711. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from placenta previa on 20-SEP-2021, maternal exposure during pregnancy on 26-JAN-2022, and fever 99.9 fahrenheit (°f) on 23-MAY-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and placenta previa as unassessable. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, and fever 99.9 fahrenheit (°f). Company causality between covid-19 vaccine ad26.cov2.s, and placenta previa, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and fever 99.9 fahrenheit (°f) was related.  This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from consumer on 15-MAR-2022, the following information was updated and incorporated into case narrative: Patient initials, height and weight were added. Pregnancy and delivery information was added. Additional event placenta previa was added. Single umbilical artery was removed as an adverse event and moved to medical history. Concomitant medications were added. Lab data was added (body temperature, body mass index).; Sender's Comments: V1: The follow up information in this version updates Patient initials, height and weight. Pregnancy and delivery information. Additional event placenta previa was added (serious). Single umbilical artery was removed as an adverse event and moved to medical history. Concomitant medications and Lab data. Causality for new serious event placenta praevia assessed.   20211143825-covid-19 vaccine ad26.cov2.s-placenta praevia. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.