Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Hyperemesis gravidarum, Pre-eclampsia
Clinical narrative: PRE-ECLAMPSIA; MATERNAL EXPOSURE DURING PREGNANCY; HYPEREMESIS GRAVIDARUM; This solicited pregnancy report received from a consumer concerned a 21 year old female. The patient was enrolled in a non-company sponsored study. The patient's height, and weight were not reported. The patient's concurrent conditions included: disability, anxiety, asthma, bipolar disorder, depression, primigravida, tobacco user (Before and during pregnancy, 10 or fewer), e-cigarette smoker (Before and during pregnancy, several times a day.), recreational drug use (Before and during pregnancy, daily), and non alcoholic, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient was gravida 1 and para 0. The date of the patient's last menstrual period was 14-DEC-2020. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (at gestational age 15 weeks and two days) (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 29-JAN-2023) .5 ml, administered on 01-APR-2021 for covid-19 immunisation. Age at time of vaccination 21 years old. Concomitant medications included prenatal vitamins(minerals nos and vitamins nos), asenapine maleate, cyclobenzaprine hydrochloride, escitalopram oxalate, and lamotrigine. On 01-APR-2021, the patient experienced maternal exposure during pregnancy (dose number in series 1). The date of the patient's last menstrual period was 14-DEC-2020. On an unspecified date (at gestational age 38 weeks), the patient experienced pre-eclampsia (dose number in series 1). On an unspecified date, the pregnancy resulted in an unknown. The type of pregnancy was reported as singleton. Expected delivery date was 20-SEP-2021. At gestational age 37 weeks, the patient vaginally delivered a full-term, live, female neonate. The labor was induced due to pre-eclampsia. The patient spent three days in hospital for delivery. Neonate's birth weight was 7 pounds and 2 ounces, body length was 20 inches. With minimal and insufficient data provided to further assess this case, the reported hyperemesis gravidarum was considered to be unassessable. On 2021, the patient experienced hyperemesis gravidarum (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from maternal exposure during pregnancy, and pre-eclampsia on SEP-2021, and the outcome of hyperemesis gravidarum was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and hyperemesis gravidarum as unassessable, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, and pre-eclampsia as not related. Company causality between covid-19 vaccine ad26.cov2.s, and hyperemesis gravidarum was not related.  This report was serious (Other Medically Important Condition).  Case was reassessed as serious based on the additional information received from the consumer/other non health professional on 04-JAN-2024. The following information was updated and/or incorporated into the case/case narrative: Concurrent conditions (Nonalcoholic, Disability, Anxiety, Asthma, Bipolar disorder, Depression, Primigravida, Tobacco user, E-cigarette smoker, Recreational drug use), new event (hyperemesis gravidarum), event dates for pre-eclampsia, outcome of pre-eclampsia, concomitant medication (prenatal vitamins(minerals nos and vitamins nos), cyclobenzaprine hydrochloride, escitalopram oxalate, lamotrigine, asenapine maleate), expected Delivery Date, narrative information (The type of pregnancy was reported as singleton and narrative information (At gestational age 37 weeks, the patient vaginally delivered a full-term, live, female neonate. The labor was induced due to pre-eclampsia. The patient spent three days in hospital for delivery. Neonate's birth weight was 7 pounds and 2 ounces, body length was 20 inches. With minimal and insufficient data provided to further assess this case, the reported hyperemesis gravidarum was considered to be unassessable) and made Pre-eclampsia as serous event.; Sender's Comments: V2: Case made serious in the current version with addition of serious event of hyperemesis gravidarum and update in the event of pre eclampsia to serious (reported as the reason for induction of labour).  COVID-19 VACCINE AD26.COV2.S- Hyperemesis gravidarum, Pre-eclampsia- the events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events. Specifically: MEDICAL HISTORY (cigarette smoking during pregnancy is associated with an increased incidence of pre eclampsia), NATURE OF EVENT (hyperemesis is more common among primigravid women). Therefore, these events are considered inconsistent with vaccine administration.