Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Fatigue, Malaise, Pain in extremity
Clinical narrative: POLYHYDRAMNIOS; PREECLAMPSIA; SORE ARM; FATIGUE; MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; This solicited pregnancy report received from a consumer concerned a 27 year old female of unspecified ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 104.31 kilograms, and height was 160 centimeters. The patient's concurrent conditions included: multigravida, body mass index increased to 40.735, non-tobacco user, and non-alcoholic, no recreational drug use and other pre-existing medical conditions included: The patient's obstetrical history included one previous pregnancy, resulting in a live baby. The patient was gravida 2, para 2. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total, administered on 14-MAR-2021 for covid-19 immunisation. The batch number was not reported and has been requested. Concomitant medications included Aspirin 81 (acetylsalicylic acid) and prenatal vitamins (once a daily) used for unknown indication.  On 14-MAR-2021, the patient experienced maternal exposure during pregnancy, chills, feeling unwell, and fatigue. At the time of vaccination, the gestation period was 2 weeks. The date of the patient's last menstrual period was 22-FEB-2021 and expected delivery date was 29-NOV-2021. On 15-MAR-2021, the patient experienced sore arm. On 23-NOV-2021, the patient experienced preeclampsia. On 29-NOV-2021, the patient experienced polyhydramnios. At gestational age 40 weeks and one day, the pregnancy resulted in a live birth. The patient delivered vaginally a live, female, full-term neonate. The patient spent two days in the hospital for the delivery. The patient gave birth to a female baby with birth weight 10 pounds and 3 ounces, and body length 22 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from polyhydramnios, and preeclampsia on NOV-2021, and chills, feeling unwell, sore arm, and fatigue on 15-MAR-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 polyhydramnios, preeclampsia, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, sore arm, and fatigue was related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210914235.  This case was reassessed as serious based on additional information received from consumer on 15-FEB-2022. The following information was updated and incorporated into case narrative: The patient medical history: height, social history (non-tobacco user, non-alcoholic, no recreational drug use), body mass index increased, patient's pregnancy details (outcome, para, gravida, child details, expected delivery date, end of pregnancy date, gestation period). The new events added: polyhydramnios with seriousness criteria as other medically important condition and preeclampsia as non-serious. The outcome for chills, feeling unwell, fatigue and sore arm updated to recovered/resolved with cessation date as 15-MAR-2021, duration of events updated.; Sender's Comments: V1: This follow up adds information about medical history, body mass index increased, patient's pregnancy details, new events added: polyhydramnios with seriousness criteria as other medically important condition and preeclampsia as non-serious, outcome updated. This updates the case from V0 non serious to V1 serious. 20210760731-covid-19 vaccine ad26.cov2.s-polyhydramnios. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.