Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cervix haematoma uterine, Exposure during pregnancy, Pre-eclampsia, Prolonged labour
Clinical narrative: HEMATOMA ON CERVIX; PRE-ECLAMPSIA; LABORED FOR 15 HOURS, STUCK AT 9 CM FOR 6 HRS; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a health care professional concerned a 29 year old  female of unspecified ethnic origin. The patient was enrolled in a non-company sponsored study COVID 19 Vaccines Pregnancy Exposure Registry number: private). The patient's weight was 81.633 kilograms, height was 160 centimeters and Body mass index (BMI) was 31.88. The patient had history of tobacco, e-cigarette and recreational drug use, however reported no alcohol use. The patient had no relevant obstetrical history. The patient's concurrent conditions included anxiety, endometriosis and body mass index increased. The patient was gravida 1, para 1 and gestation period was 13 weeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total administered on 21-MAY-2021 (at gestational age 15 weeks) for prevention of covid 19. Concomitant medications included Prozac (fluoxetine hydrochloride) for drug used for unknown indication, and prenatal vitamins (Minerals NOS/Vitamins NOS) for drug used for unknown indication. On 21-MAY-2021, the patient experienced maternal exposure during pregnancy. The first day of the last menstrual period (LMP) was calculated to be 05-FEB-2021. The estimated delivery date (EDD) was reported to be 12-NOV-2021. Type of pregnancy was reported as singleton. On 06-Nov-2021, the patient was diagnosed with pre-eclampsia. Pre-eclampsia presented with complex migraines with visual field loss twice. The study participant had bilateral occipital nerve blocks done with success. On an unspecified date in NOV-2021, the patient experienced labored for 15 hours, stuck at 9 cm for 6 hrs. The patient was stuck at 9cm for 6 hours due to a hematoma on her cervix. On 07-NOV-2021, at gestational age 39 weeks and two days, the patient delivered a live, female, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was labor lasting for 15 hours. The study participant spent three days in the hospital for the delivery. The neonate's birth weight was 7 pounds and 10 ounces, body length 20 inches. Birth outcome was normal. The neonate was admitted in the Neonatal Intensive Care Unit (NICU) after the delivery due to apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from labored for 15 hours, stuck at 9 cm for 6 hrs and maternal exposure during pregnancy on 07-NOV-2021, and pre-eclampsia on 30-DEC-2021, and the outcome of hematoma on cervix was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, labored for 15 hours, stuck at 9 cm for 6 hrs, hematoma on cervix, and pre-eclampsia was not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20220232600.  This case was reassessed as serious based on additional information received from study participant (patient) on 03-FEB-2022. The following information was updated and incorporated into the case narrative: Added patient height (160 cm), race (white) and Body mass index increased ( 31.88), no alcohol use added to patient history. Body mass index (BMI) was 31.88. Patient history including pre-existing conditions updated (The patient had no relevant obstetrical history. The patient was gravida 1, para 1 and gestation period was 13 weeks.). Labored for 15 hours, stuck at 9 cm for 6 hrs, hematoma on cervix, and pre-eclampsia added as adverse events. Outcome of event maternal exposure during pregnancy updated to recovered. Case upgraded to serious (Other Medically Important Condition). Delivery details added. Narrative updated accordingly.; Sender's Comments: V1: 20210801118-covid-19 vaccine ad26.cov2.s-Maternal exposure during pregnancy. 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20210801118-covid-19 vaccine ad26.cov2.s-, Labored for 15 hours, stuck at 9 cm for 6 hrs, Hematoma on cervix, Pre-eclampsia. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.