Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Headache, Induced labour, Premature delivery, Ultrasound scan
Clinical narrative: Induction via balloon catheter due to elevated blood pressure; Cord prolapse / Hand presentation; Premature delivery; Headache; Chills; Fatigue; Elevated blood pressure; Exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UMBILICAL CORD PROLAPSE (Cord prolapse / Hand presentation), INDUCED LABOUR (Induction via balloon catheter due to elevated blood pressure), PREMATURE DELIVERY (Premature delivery) and BLOOD PRESSURE INCREASED (Elevated blood pressure) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lactose intolerance (Mild), ADHD (Stable) and Depression (Stable, medication Wellbutrin discontinued due to pregnancy.). Concomitant products included METHYLPHENIDATE from 01-Feb-2018 to an unknown date for ADHD, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) 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-Apr-2020 and the estimated date of delivery was 18-Feb-2021. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). On 27-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure) (seriousness criterion medically significant). On 28-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). On 29-Jan-2021 at 5:30 PM, the patient experienced INDUCED LABOUR (Induction via balloon catheter due to elevated blood pressure) (seriousness criterion hospitalization). On 30-Jan-2021, the patient experienced PREMATURE DELIVERY (Premature delivery) (seriousness criterion hospitalization prolonged). On 30-Jan-2021 at 6:00 AM, the patient experienced UMBILICAL CORD PROLAPSE (Cord prolapse / Hand presentation) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 29-Jan-2021 due to INDUCED LABOUR. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  forty-first week of the pregnancy. The cesarean delivery occurred on 30-Jan-2021, which was reported as Premature. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Pre-Term Birth NOS. The baby, female, was delivered at 37.2 weeks and therefore it is considered pre-term. Cord prolapse/hand presentation was discovered at cervical check post-induction by balloon catheter, therefore an immediate C-section delivery was performed. No abnormalities/complications for the infant, currently breastfeeding. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown. On 29-Jan-2021, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. On 30-Jan-2021, UMBILICAL CORD PROLAPSE (Cord prolapse / Hand presentation), INDUCED LABOUR (Induction via balloon catheter due to elevated blood pressure) and PREMATURE DELIVERY (Premature delivery) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2020, Ultrasound abdomen: normal (normal) normal-8-week ultrasound.. On 10-Aug-2020, Ultrasound abdomen: 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) abnormal. On 29-Jan-2021, Blood pressure measurement: 142/98 (High) abnormal, sent for induction..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports she had an unwanted/unplanned induction 2 days after her second Moderna vaccine dose. Her blood pressure was found to be elevated on 27-Jan-2021 at her 36 weeks prenatal visit and she was informed she will be admitted for induction if the blood pressure does not return to normal. Between 28-29 of January, 2021 she experienced mild side effects, which she managed with ibuprofen and rest. On 29-Jan-2021 her blood pressure was re-checked and confirmed to be elevated so she was admitted for induction at 5:30pm via balloon catheter. Approximately at 6:00am on 30-Jan-2021, the patient was found to have a cord prolapse/hand presentation and was immediately scheduled for C-section delivery. She delivered at 6:10AM. No family history of congenital abnormalities/genetic diseases. Besides the mild lactose intolerance, no allergies reported.  Treatment medications were not reported.  This is a case of drug exposure during pregnancy with associated AEs (elevated blood pressure, umbilical cord prolapse, induced labor, premature delivery) 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; Sender's Comments: This is a case of drug exposure during pregnancy with associated AEs (elevated blood pressure, umbilical cord prolapse, induced labor, premature delivery) 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.