Sex: F
Vaccine: COVID19
Symptoms: Abnormal cord insertion, Blood test, Exposure during pregnancy, Ultrasound scan
Clinical narrative: MARGINAL CORD INSERTION; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 32 year old female. The patient's weight was 63.49 kilograms, and height was not reported. The patient's past medical history included: miscarriage, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient had no history of tobacco, alcohol, or recreational drug use. Type of pregnancy was reported as singleton. The gestational age was four weeks and six days. The date of the patient's last menstrual period was 02-MAR-2021 and expected delivery date was 07-DEC-2021. The pregnancy was continuing. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prevention of COVID-19. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included minerals nos/vitamins nos.  On unknown date during 2021, the patient had blood tests, such as cell-free DNA screening, alfa fetoprotein, or the quad screen and a nuchal translucency screen test. None of the tests showed any problem or concern.  On 05-APR-2021, the patient experienced maternal exposure during pregnancy. On 20-JUL-2021, the patient experienced marginal cord insertion. Laboratory data included: Diagnostic ultrasound (NR: not provided) which showed marginal cord insertion.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the maternal exposure during pregnancy and marginal cord insertion was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy and marginal cord insertion was not related.  This report was serious (Other Medically Important Condition).  Additional information was received from patient on 06-Oct-2021. The following information was updated and incorporated into the case narrative: Event (marginal cord insertion added), lab (prenatal ultrasound added) and narrative.; Sender's Comments: V1: 20210763185-covid-19 vaccine ad26.cov2.s-Marginal cord insertion. This event(s) is considered not related. 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 .   20210763185-covid-19 vaccine ad26.cov2.s- Maternal exposure during pregnancy. This event(s) is considered not related. 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: SPECIAL SITUATIONS