Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein, Eclampsia, Exposure during pregnancy, Fatigue, Injection site swelling
Clinical narrative: Premature delivery WEEKS; PRE-ECLAMPSIA; ECLAMPSIA; FATIGUE; MUSCLE PAIN; SWELLING AT INJECTION SITE; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 36 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 115.65 kilograms, and height was not reported. The patient's concurrent conditions included: anxiety, depression, type II diabetes mellitus, blood pressure high, polycystic ovarian syndrome, and overweight. The patient was gravida 1, para 1. The patient had no obstetrical history and did not use drugs for recreational use, tobacco, or alcohol. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number unknown, expiry unknown) dose was not reported, 01 total, administered on 24-MAR-2021 for COVID-19 immunisation. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included caffeine/magnesium salicylate (Diurex Water Pills), docosahexaenoic acid (Prenatal DHA), insulin aspart (Novolog), insulin detemir (Levemir), saccharated iron oxide (Venofer), Labetalol, losartan potassium, and nifedipine (Procardia) for unknown indication,  On 24-MAR-2021, the patient had maternal exposure during pregnancy, muscle pain, swelling at injection site. On 26-MAR-2021, the patient experienced fatigue. On 01-JUL-2021, the patient had pre-eclampsia. On an unspecified date in JUL-2021, the patient had eclampsia. The date of the patient's last menstrual period was 30-OCT-2020 and delivery resulted in a live birth (premature delivery.The patient gave birth via caesarean section (C- section). The female baby weighed 5.5 pound and was 20-inch height. Gestation period was 35 weeks and two days at the time of delivery (20 weeks at the time of event onset). The patient spent four days in the hospital for the delivery. On an unspecified date, the patient was hospitalized, number of days hospitalized, and discharge information was not reported. On an unspecified date, laboratory data included: Alphafetoprotein, Foetal nuchal translucency ultrasound, Prenatal cell-free DNA screening, quada and results were normal (no problem detected).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 29-MAR-2021, and muscle pain, and swelling at injection site on 31-MAR-2021, had not recovered from eclampsia, and pre-eclampsia, and the outcome of maternal exposure during pregnancy and premature delivery was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and eclampsia, and pre-eclampsia as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and premature delivery, maternal exposure during pregnancy, fatigue, muscle pain, and swelling at injection site. Company causality between covid-19 vaccine ad26.cov2.s, and premature delivery, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and fatigue, muscle pain, and swelling at injection site was related.  This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage). This parent/child case is linked to 20211009718.  Additional information was received from consumer on 05-OCT-2021. The following information was updated and incorporated into the case narrative: New events (Eclampsia, premature delivery weeks and pre-eclampsia), maternal exposure during pregnancy serious updated to serious, Pregnancy outcome (live birth), Pregnancy type (Retrospective), date of pregnancy, causality and all concomitant medications.; Sender's Comments: V1: This version updates information about: New events (Eclampsia, premature delivery and pre-eclampsia), maternal exposure during pregnancy updated to serious, Pregnancy outcome (live birth), Pregnancy type (Retrospective), date of pregnancy, causality and all concomitant medications. 20210800681-COVID-19 VACCINE AD26.COV2.S- Eclampsia, pre-eclampsia, delivery at premature delivery weeks. Follow-up received regarding Clinical Details. 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: UNDERLYING DISEASE 20210800681-COVID-19 VACCINE AD26.COV2.S- Maternal exposure during pregnancy. Follow-up received regarding Clinical Details. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS