Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pre-eclampsia, Pyrexia
Clinical narrative: PRE-ECLAMPSIA; FEVER DURING LABOUR; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 35 year old female of an unspecified ethnicity. The patient was enrolled in a non-company sponsored study: (patient number: C12249). The patient's weight was 72.56 kilograms, and height was 175 centimeters. The patient's past medical history included: miscarriage (One past pregnancy), and concurrent conditions included: anxiety, depression, and multigravida (One past pregnancy), and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient was gravida 2. The patient had no history of tobacco, alcohol, or recreational drug use. The first day of the last menstrual period (LMP) was calculated to be 24-Mar-2021. The estimated delivery date (EDD) was reported to be 29-Dec-2021. Type of pregnancy was reported as singleton. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 20-JUN-2021 for covid-19 immunisation. On 20-JUN-2021, the patient experienced sore arm, fever, vomiting, and maternal exposure during pregnancy (dose number in series 1). On 15-SEP-2021, the patient experienced anaemia (dose number in series 1). The patient recovered from sore arm on 22-JUN-2021, fever on 21-JUN-2021, vomiting on 20-JUN-2021, and anaemia on 15-OCT-2021. The patient received booster with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, (drug start period: 176 days; drug last period: 36 days), 1 total administered on 07-NOV-2021 (at gestational age 32 weeks) for prevention of covid-19. Age at time of vaccination 35 years old. The batch number was not reported and has been requested. Concomitant medications included bupropion, minerals nos/vitamins nos, and venlafaxine hydrochloride. On 07-NOV-2021, the patient experienced recurrence of maternal exposure during pregnancy (dose number in series 2). On 13-Dec-2021, the patient was diagnosed with pre-eclampsia and hospitalized due to the condition (dose number in series 2). At gestational age 38 weeks, the patient delivered vaginally a live, full-term, male neonate. Delivery was induced due to pre-eclampsia. It was additionally reported that the patient experienced fever during labour (dose number in series 2). The patient spent six days in the hospital for the delivery. The pregnancy outcome was reported as live birth. The neonate's birth weight was 8 pounds and 6 ounces, body length 21 inches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pre-eclampsia, and maternal exposure during pregnancy, and the outcome of fever during labour was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and pre-eclampsia as unassessable, and between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, and fever during labour as not related. Company causality between covid-19 vaccine ad26.cov2.s, and pre-eclampsia and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and fever during labour was related.  This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211110942 (dose number in series 1).; Sender's Comments: V0-20220508776-covid-19 vaccine ad26.cov2.s- Pre-eclampsia. 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. (Advanced maternal age- 35 years)