Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic, Exposure during pregnancy, Gestational hypertension
Clinical narrative: GESTATIONAL HYPERTENSION; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 33 year old female.  The patient was enrolled in a non-company sponsored study. The patient's weight was 90.7 kilograms, and height was 180 centimeters. The patient's concurrent conditions included: multigravida, and other pre-existing medical conditions included: The patient does not have history of tobacco, alcohol or recreational drug use. The patient was gravida 2, para 1. The patient obstetrical history included two previous pregnancies; one resulting in a live baby, while the outcome for the other pregnancy was not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 1 total administered on 24-MAR-2021 for prevention of covid-19. Drug start period and last period was 133 days. Concomitant medications included escitalopram oxalate (lexapro), minerals nos/vitamins nos, and omeprazole (delayed release).  On 24-MAR-2021, the patient experienced maternal exposure during pregnancy. The date of the patient's last menstrual period was 26-NOV-2020 and expected delivery date was 02-SEP-2021. Type of pregnancy was reported as singleton. On 04-AUG-2021, the patient experienced gestational hypertension. At gestation age of 36 weeks, the patients systolic blood pressure was 133, 144 and 165. The patient did not remember the diastolic numbers. On 20-AUG-2021, the systolic numbers continuing to be in the 140s and 150s, the study participant was induced. On 21-AUG-2021 at gestation age of 36 weeks the patient delivered vaginally a live female, full-term, neonate. The patient spent two days in the hospital for the delivery. The neonate's birth weight was 8 pounds and 8 ounces, body length was 21 inches. On 22-AUG-2021. the patient was discharged from the hospital with instructions to check blood pressure at home and follow-up with obstetrician-gynaecologist for a blood pressure check in three days. On 23-AUG-2021, Blood pressure check at home was 165/90. The patient went to the emergency room and was re-admitted to the hospital with severely high blood pressure. Protocol was implemented, included magnesium drip due to seizure risk. Labetalol was introduced and after appropriate dose for maintaining the blood pressure down was identified, the patient was sent home on 25-Aug-2021.  Weekly blood pressure checks followed until it finally dropped into the normal range (without medications) at eight weeks post-partum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gestational hypertension on 08-OCT-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and gestational hypertension was related. This report was serious (Hospitalization Caused / Prolonged).  This case was reassessed as serious based on additional information received from a consumer on 05-NOV-2021, the following information was updated and incorporated into case narrative: Patient history (Multigravida). Patient height and race. Patient History Including Pre-Existing Medical Conditions. Patient pregnancy detail (para, gravida, Expected Delivery Date, child information). Event (Gestational hypertension ). Lab test ( systolic blood pressure, blood pressure). Batch number for suspect product. Concomitant medication (omeprazole and Lexapro). Drug use to treat AE (Labetalol) was added.; Sender's Comments: V1:20210800900-COVID-19 VACCINE AD26.COV2.S -Gestational hypertension. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210800900-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