Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pre-eclampsia
Clinical narrative: PRE-ECLAMPSIA; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a patient concerned a 36 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 60.32 kilograms, Body Mass Index (BMI) was 23.37 and height was not reported. The patient's past medical history included: high blood pressure of pregnancy, (both pregnancies, first one in //2017) and concurrent conditions included: multigravida,other pre-existing medical conditions  the study participant had no history of exposure to drugs for recreational use, tobacco or alcoholic beverage. The patient initiated treatment with covid-19 vaccine ad26.cov2.s, at gestational age 33 weeks days (suspension for injection, intramuscular and batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 for covid-19 immunisation. Drug start period and drug last period was 28 days. Concomitant medications included magnesium for drug used for unknown indication, and docosahexaenoic acid. The date of the patient's last menstrual period was 19-AUG-2020. The estimated delivery date (EDD) was reported to be 26-May-2021. It was reported that this was a singleton pregnancy. On 10-APR-2021, the patient experienced maternal exposure during pregnancy. On 08-MAY-2021, patient experienced pre-eclampsia .She had magnesium IV during labour /delivery and for following 24 hours after that. At gestational age of 37 weeks and 3 days, the patient delivered live female neonate vaginally, the pregnancy resulted in a live birth. The patient gave birth to a female, 7 pound, 20 inch baby. She was using an unspecified blood pressure pill for the following month until blood pressure was normalized. Birth outcome was normal. Patient spent two days in the hospital for delivery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pre-eclampsia on 14-JUN-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and pre-eclampsia as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality of covid-19 vaccine ad26.cov2.s, with maternal exposure during pregnancy and pre-eclampsia was not related. This report was serious (Hospitalization Caused / Prolonged).  Additional information received on 30-Jul-2021 from patient. The following information was updated and incorporated into the case narrative: The event of preeclampsia added. Concomitant medication magnesium and concomitant condition blood pressure added. Case upgraded to serious. Birth outcome, EOP date, child information (body weight and length), gestation period updated to 33 weeks (previously reported as 23 weeks) Narrative updated/accordingly.; Sender's Comments: V1: Additional information received in this version updates:  The event of preeclampsia added. Concomitant medication magnesium and concomitant condition blood pressure added. Case upgraded to serious. Birth outcome, EOP date, child information (body weight and length), gestation period updated to 33 weeks (previously reported as 23 weeks).  20210728370-COVID-19 VACCINE AD26.COV2.S-Pre-eclampsia. 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 20210728370-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