Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Fatigue, Haemorrhage, Nausea
Clinical narrative: LABOR NOT PROGRESSING; BLEEDING; MATERNAL EXPOSURE DURING PREGNANCY; DIZZY; NAUSEA; FATIGUE; This solicited pregnancy report received from a consumer concerned a 34 year old female with an unspecified race. The patient was enrolled in a non-company sponsored study. The patient's weight was 56 kilograms, and height was not reported. The patient's concurrent conditions included: primigravida, no alcohol use, non-tobacco user, and no recreational drug user, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient was gravida 1 and para 1. The patient had no relevant medical history and obstetrical history. Type of pregnancy was reported as singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 17-MAY-2021 (at gestational age 32 weeks and one day) for covid-19 immunisation. The batch number was not reported and has been requested. Age at time of vaccination 34 years old. Concomitant medications included minerals nos/vitamins nos (prenatal vitamins), acetylsalicylic acid (aspirin), and folic acid.  On 17-MAY-2021, the patient experienced dizzy, nausea, and fatigue. On 17-MAY-2021, the patient experienced maternal exposure during pregnancy. The date of the patient's last menstrual period was 04-OCT-2020 and expected delivery date was 11-JUL-2021. On 05-JUL-2021, at gestational age 39 weeks and one day, the patient delivered a live, full-term, female neonate via caesarean method of delivery (C-section). The patient spent 3 days at the hospital for the delivery. The primary reason for C-section was reported as labor not progressing. The patient gave birth via caesarean section to a 3.231 kilogram, 20 inch, female baby. On the same day, the patient experienced bleeding (hemorrhage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from labor not progressing, and maternal exposure during pregnancy on 05-JUL-2021, and dizzy, nausea, and fatigue on 17-MAY-2021, and the outcome of bleeding was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and bleeding, labor not progressing, and maternal exposure during pregnancy as not related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and dizzy, nausea, and fatigue. Company causality between covid-19 vaccine ad26.cov2.s, and dizzy was not related, and between covid-19 vaccine ad26.cov2.s, and nausea, and fatigue was related.  This report was serious (Other Medically Important Condition).  This case was reassessed as serious based on additional information received from consumer on 26-JAN-2023, the following information was updated and incorporated into case narrative: patient ethnicity, pre-existing medical conditions, concurrent conditions added, patient pregnancy details (gestation period, para, expected delivery date, EOP date) and child information (sex, weight, height, gestation age) added, pregnancy outcome updated to live birth, outcome, cessation date and seriousness of the event maternal exposure during pregnancy updated to 05-JUL-2022, recovered/resolved and to other medically important condition, outcome and cessation dates of the events dizzy, nausea, and fatigue updated to 05-JUL-2022 and recovered/resolved, events (bleeding and labor not progressing) added, indication updated to covid-19 immunization and batch/lot number sentence updated, dose number in series added in event and product tab, concomitant products added, reporter causality for the event maternal exposure during pregnancy updated to not related and narrative was updated.; Sender's Comments: V1: This follow up adds information about pre-existing medical conditions, concurrent conditions added, patient pregnancy details, pregnancy outcome, events cessation date, outcome, cessation date and seriousness, new serious events (bleeding and labor not progressing), outcome dates, vaccination details, concomitant products, reporter causality. This updates the case from non serious to serious.  20210760905-labor not progressing. Follow-up received regarding Clinical Details. 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. Specifically: MEDICAL HISTORY (primigravida). Therefore, this event is considered inconsistent with vaccine administration.  20210760905-Maternal exposure during pregnancy. Follow-up received regarding Clinical Details. 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.  20210760905-Bleeding. Follow-up received regarding Clinical Details. 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. Specifically: CONMEDS-OTHER SUSPECT DRUGS (Concomitant medications-acetylsalicylic acid (aspirin)). Therefore, this event is considered inconsistent with vaccine administration.