Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Exposure during pregnancy, Fatigue
Clinical narrative: This spontaneous retrospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of UMBILICAL CORD PROLAPSE (cord prolapse) and BLOOD PRESSURE INCREASED (elevated blood pressure) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K2A and 032L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: TDAP on 30-Nov-2020. Concurrent medical conditions included Pregnant, Lactose intolerance (mild lactose intolerance), ADHD (stable, changed from concerta ER methypenidate to Ritalin IR methylphenidate during 2nd trimester) since 2018 and Depression (since teens;stable,Wellbutrin discontinued with pregnancy). Concomitant products included METHYLPHENIDATE from 01-Jan-2018 to an unknown date for ADHD, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-Jan-2019 to an unknown date for Nutritional support.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 14-Feb-2020 and the estimated date of delivery was 18-Feb-2021. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 27-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure) (seriousness criterion hospitalization). On 28-Jan-2021, the patient experienced FATIGUE (mild fatigues) and HEADACHE (Headache). On 29-Jan-2021, the patient experienced CHILLS (chills). On 30-Jan-2021, the patient experienced UMBILICAL CORD PROLAPSE (cord prolapse) (seriousness criterion hospitalization). The patient was hospitalized from 29-Jan-2021 to 01-Feb-2021 due to BLOOD PRESSURE INCREASED and UMBILICAL CORD PROLAPSE. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  forty-fifth week of the pregnancy. The cesarean delivery occurred on 30-Jan-2021, which was reported as Full-term. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. Cord prolapsed hand presentation discovered at cervical check post-induction by balloon catheter. Immediate C-section delivery. Delivered at 6:10 am. On 31-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 29-Jan-2021, FATIGUE (mild fatigues) and HEADACHE (Headache) had resolved. On 30-Jan-2021, UMBILICAL CORD PROLAPSE (cord prolapse) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure) had not resolved and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2020, Pregnancy test: positive (Positive) positive. On 10-Jul-2020, Ultrasound antenatal screen: normal (normal) Normal. On 10-Aug-2020, Scan: normal (normal) Normal. On 02-Oct-2020, Ultrasound abdomen: normal (normal) Normal. On 30-Nov-2020, Glucose tolerance test: normal (normal) normal. On 27-Jan-2021, Blood pressure measurement: 142/94 (High) high. On 29-Jan-2021, Blood pressure measurement: 142/98 (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered UMBILICAL CORD PROLAPSE (cord prolapse) to have an unknown relationship. No further causality assessments were provided for BLOOD PRESSURE INCREASED (elevated blood pressure), EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (mild fatigues), HEADACHE (Headache) and CHILLS (chills).    Patient treated mild vaccine effects (fatigue, headache, chills) with ibuprofen and rest.  This is a case of drug exposure during pregnancy with associated AEs (elevated blood pressure, umbilical cord prolapse, induced labor) for this 29-year-old female. Patient delivered a female child at 37 wks. 2 days. Based on the current available information and temporal association between the use of the product and the start date of these events (headache, chills, fatigue), a causal relationship cannot be excluded. Further information is requested to monitor the newborn.   This case was linked to MOD-2021-080907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow up received on 07/04/2021. Additional information included  Cord prolapse, headache, chill, nausea. Lab data included.  Concomitant medication history included. Second dose of vaccine information. Relevant medical history. Delivery information.; Sender's Comments: This is a case of drug exposure during pregnancy with associated AEs (elevated blood pressure, umbilical cord prolapse, induced labor) for this 29-year-old female. Patient delivered a female child at 37 wks. 2 days. Based on the current available information and temporal association between the use of the product and the start date of these events (headache, chills, fatigue), a causal relationship cannot be excluded. Further information is requested to monitor the newborn.