Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test, Prenatal screening test, Ultrasound abdomen, Ultrasound antenatal screen, Ultrasound foetal
Clinical narrative: Postpartum preeclampsia 5 days postpartum; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PRE-ECLAMPSIA (Postpartum preeclampsia 5 days postpartum) in a 40-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth, Complications of previous pregnancy reported induction at 37 weeks,) on 16-Aug-2019, Alcoholic (2-3 drinks/week) from August 1999 to 21-Mar-2021, Gestational hypertension (Chronic hypertension prior to pregnancy-(diagnosed at 32 weeks),) and Pre-eclampsia (postpartum pre-eclamsia (hospital re-admission at day 5 postpartum), three day NICU stay for infant: surfactant administration and jaundice.). Concurrent medical conditions included Reflux oesophagitis (Started daily Pepcid for treatment.) since 24-Mar-2021, Hypertension (Labetalol 100mg twice daily (previously taking Bystolic). Better during pregnancy, returned following childbirth) since 20-Aug-2019, Drug allergy (Benadryl) and Obesity. Concomitant products included PARACETAMOL (TYLENOL) for Headache and Back pain, LABETALOL for Hypertension, ONDANSETRON (ZOFRAN [ONDANSETRON]) from 26-Apr-2021 to 26-Apr-2021 for Nausea, FAMOTIDINE (PEPCID [FAMOTIDINE]) from 24-Mar-2021 to an unknown date for Reflux oesophagitis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 21-Mar-2021 to an unknown date and LETROZOLE for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 28-Feb-2021 and the estimated date of delivery was 05-Dec-2021. On 17-Nov-2021, the patient experienced PRE-ECLAMPSIA (Postpartum preeclampsia 5 days postpartum) (seriousness criterion hospitalization). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy. The patient had a vaginal delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 454 grams (1lbs 0oz). The outcome was reported as Delivered NOS. Head circumference was 35 cm, length was 50.8 cm, Gestation week was 37 week for fetus. The patient was treated with NIFEDIPINE (PROCARDIA [NIFEDIPINE]) for Adverse event, at an unspecified dose and frequency and MAGNESIUM SULFATE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRE-ECLAMPSIA (Postpartum preeclampsia 5 days postpartum) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Pregnancy test: positive (Positive) Positive. On 26-Apr-2021, Ultrasound scan vagina: normal (normal) Normal. In May 2021, Electrocardiogram: normal (normal) Normal. On 28-May-2021, Prenatal screening test: normal (normal) No chromosomal abnormalities detected.. On 28-May-2021, Ultrasound abdomen: normal (normal) Normal. On 28-May-2021, Ultrasound antenatal screen: normal (normal) Normal. In July 2021, Echocardiogram: normal (normal) Normal. In July 2021, Ultrasound foetal: normal (normal) Normal. In September 2021, Glucose tolerance test: 3 hr test normal (normal) 3 hr test normal. In October 2021, Foetal non-stress test: normal (normal) normal. In October 2021, Ultrasound abdomen: normal (normal) Weekly ultrasounds (size, biophysical profile) - all normal until 37 weeks 16/Nov/2021 (passed subsequent NST). On an unknown date, Foetal non-stress test: normal (normal) Also her other weekly non-stress tests were normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.  The patient tried to get pregnant for over a year with her first child. An extensive testing were performed but did not find any reason for the issues. Eventually she became pregnant in the third month after taking Letrazole.  On 17-Nov-2021 it was reported as Postpartum preeclampsia 5 days postpartum, the patient was readmitted to hospital for 48 hours and was started on magnesium sulfate, as her blood pressure was not reduced with labetalol or Procardia. No perinatal complications for the infant. No identified fetal/infant abnormalities on delivery. No identified infant abnormalities at 1-month post-partum.   Company Comment - This  case concerns a 40 year old female patient with medical history of gestational hypertension and pre-eclampsia who experienced the serious unexpected event of pre-eclampsia. The event occurred 7 months and 5 days after the second dose of mRNA-1273 vaccine. Patient was admitted to hospital for 48 hours, magnesium sulfate was administered. Patient's medical history of gestational hypertension and pre-eclampsia remains a confounder. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-060882 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non-significant follow up appended On 01-Feb-2022: On 01-Feb-2022 follow up was appended which is significant Pre-eclampsia event added, Medical history, lab details and treatment medications added.; Sender's Comments: This case concerns a 40 year old female patient with medical history of gestational hypertension and pre-eclampsia who experienced the serious unexpected event of pre-eclampsia. The event occurred 7 months and 5 days after the second dose of mRNA-1273 vaccine. Patient was admitted to hospital for 48 hours, magnesium sulfate was administered. Patient's medical history of gestational hypertension and pre-eclampsia remains a confounder. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.