Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body mass index, Body temperature, Breakthrough COVID-19, Computerised tomogram
Clinical narrative: Eclamptic seizure; Breakthrough COVID-19; Maternal exposure during pregnancy; Cough; Wheezing; Major depressive disorder with postpartum onset; Pre-eclampsia; This literature-non-study retrospective pregnancy case was reported in a literature article and describes the occurrence of ECLAMPSIA (Eclamptic seizure) and MAJOR DEPRESSION (Major depressive disorder with postpartum onset) in a 39-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included COVID-19 (Overall mild infection recovered in self-isolation), Spinal fusion, Orthopaedic procedure (patient's orthopedic surgeon advised cesarean delivery under general anesthesia to prevent potential compromise of her hardware. Patient was scheduled for a cesarean section under general anesthesia at 39 weeks.) and Back surgery (Back surgeries secondary to military injuries incurred.). Previously administered products included for Pre-eclampsia: Aspirin (Low-dose aspirin) in 2021; for Product used for unknown indication: Iron in 2021 and Prenatal vitamins in 2021. Past adverse reactions to the above products included No adverse reaction with Aspirin, Iron and Prenatal vitamins. Concurrent medical conditions included Obesity (class 1) since 2021.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced ECLAMPSIA (Eclamptic seizure) (seriousness criteria hospitalization and medically significant), MAJOR DEPRESSION (Major depressive disorder with postpartum onset) (seriousness criterion medically significant), PRE-ECLAMPSIA (Pre-eclampsia), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), COUGH (Cough) and WHEEZING (Wheezing). On 27-Jul-2021, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough COVID-19). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to ECLAMPSIA. The patient had a cesarean delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 2863 grams (6lbs 5oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Despite symptoms, fetal heart rate tracing displayed a category 1 pattern. The patient was sent to labor and delivery and underwent a cesarean delivery under general anesthesia, per the advice of her orthopedic surgeon, for the management of preeclampsia. Patient had given birth to a healthy 6 lb 5 oz female neonate with Apgar scores of 8 and 9 at 1 and 5 minutes, respectively. The patient was treated with GUAIFENESIN (oral) from 2021 to 2021 for Cough, at a dose of 400 milligram; GUAIFENESIN from 2021 to 2021 for Cough, at an unspecified dose and frequency; CODEINE from 2021 to 2021 for Cough, at a dose of 40 milligram once a day; CODEINE from 2021 to 2021 for Cough, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] in 2021 at a dose of 1000 milligram once a day; VITAMIN D3 in 2021 at a dose of 4000 international unit once a day; ZINC in 2021 at a dose of 30 milligram once a day; LAVENDER OIL in 2021 at an unspecified dose and frequency; ACETAMINOPHEN in 2021 at an unspecified dose and frequency; MAGNESIUM SULFATE (intravenous) from 2021 to 2021 at a dose of maintained for 24 hours and SERTRALINE in 2021 at a dose of 25 milligram once a day. In 2021, ECLAMPSIA (Eclamptic seizure), PRE-ECLAMPSIA (Pre-eclampsia), BREAKTHROUGH COVID-19 (Breakthrough COVID-19) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, MAJOR DEPRESSION (Major depressive disorder with postpartum onset) was resolving and COUGH (Cough) and WHEEZING (Wheezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 120/79 mm Hg, 142/96 mm Hg, 146/102 mm Hg, and 156/104 mm Hg over four hours., 130/76 mm Hg on postoperative day 3, 150/90 mm Hg on one week postpartum., blood pressure between 120- 130/70- 80mm Hg at discharge. and 120/80 mm Hg at two weeks postpartum.. In 2021, Body mass index: 32.6 kilogram per square metre. In 2021, Body temperature: 36.7 degree Celsius. In 2021, Computerised tomogram: A head computed tomography (CT) was unremarkable. In 2021, Heart rate: 91 beats per minute. In 2021, Nucleic acid test: (Positive) Positive for SARS-CoV-2 at 7 weeks gestation. and (Positive) Positive for SARS-CoV-2 at 29+5 weeks gestation.. In 2021, Oxygen saturation: 97 % on room air. In 2021, Respiratory rate: 16 breaths per minute. In 2021, Ultrasound scan: demonstrated normal development and appropriate growth without evidence of intrauterine growth restriction (IUGR)..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that at 7 weeks gestation she had no other symptoms and denied SARS-CoV-2 exposure. She described an overall mild infection and recovered in self-isolation. Prior to the infection, prenatal risk factors included advanced maternal age. She was later vaccinated for SARS-CoV-2 with 2-dose vaccine at 15+1 weeks and 19+1 weeks. She developed a productive cough at 29+5 weeks on 27-Jul-2021 after a confirmed SARS-CoV-2 workplace exposure. She presented to urgent care at the onset of symptoms. She declined treatment with dexamethasone. Her symptoms improved initially, but one week later the cough worsened, and developed fatigue. She denied dyspnea, fever, headache, and chills. At 34 weeks gestation, she reported two more workplace exposures to SARS-CoV-2, less than one month after her prior infection. She developed cough and wheezing however, was not re-tested for SARS-CoV-2 and did not require treatment. At 38+4 weeks gestation, she presented to the clinic with headache unrelieved by acetaminophen. Urine protein was not obtained, her hypertension and neurologic symptoms established a diagnosis of preeclampsia. Elevated blood pressure and associated symptoms improved with delivery. The mother and infant were discharged on postoperative day 3. Several days following discharge, she began noticing progressive lower extremity edema and headache. At 1 week postpartum, she was admitted to the hospital but did not require any anti-hypertensive medications. At 2 weeks postpartum, she reported complete resolution of symptoms. At 6 weeks postpartum there were no indication of homicidal or suicidal behavior but displayed a tearful affect and significant mental distress. She reported difficulty sleeping was diagnosed with major depressive disorder with postpartum onset and started on sertraline and referred to behavioral health. At 2-month follow-up, she reported improved mood and sleep and decreased depression and anhedonia.  No concomitant medications were reported.  This Literature-non-study case of maternal exposure during pregnancy concerns a 39-year-old female patient gravida 4, with relevant medical conditions of advanced maternal age and class 1 obesity, and relevant medical history of COVID-19 approximately 2 months prior vaccination, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Eclampsia, and the unexpected and serious (due to medically significant) event of Major depression. Patient experienced COVID-19 at 7 weeks gestation, with a full recovery, and was vaccinated for SARS-CoV-2 with mRNA-1273 vaccine at 15+1 and 19+1 weeks. Her only medications were prenatal vitamins with iron and low-dose aspirin for preeclampsia prevention. At 29+5 weeks she developed a productive cough. She presented to urgent care, where vital signs were stable, and SARS-CoV-2 NAAT resulted positive. She was prescribed guaifenesin/codeine for severe cough and began taking additional vitamins (C, D3, zinc). Symptoms completely resolved. At 38+4 weeks gestation, patient presented to the clinic with a headache unrelieved by acetaminophen and hypertension, diagnosing preeclampsia. Patient underwent a cesarean delivery under general anesthesia, and gave birth to a healthy female neonate with Apgar 8/9. Symptoms improved with delivery and mother and infant were discharged on postoperative day 3. One week postpartum, she experienced hypertension, severe headache and visual disturbances followed by an eclamptic seizure. She was admitted to hospital and IV magnesium sulfate was initiated and maintained for 24 hours. A head CT was unremarkable. She was discharged after 2 days with normal blood pressures. At 6 weeks postpartum patient was diagnosed with major depressive disorder (score of 16 on Edinburgh Postnatal Depression Scale) and was started on sertraline 25 mg/day. At the 2-month follow-up, symptoms were resolving. Advanced maternal age, obesity and previous COVID-19, could be contributory factors for Eclampsia and Preeclampsia. Pregnancy complicated by 2 confirmed episodes of COVID-19, eclampsia, and isolation from family and friends could be contributory factors for Major depression. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2022: Live follow up received by safety on 30-SEP-2022 has Email received and contains significant information: Reporter information, literature information, laboratory tests, suspect information, treatment medications, event details added.; Sender's Comments: This Literature-non-study case of maternal exposure during pregnancy concerns a 39-year-old female patient gravida 4, with relevant medical conditions of advanced maternal age and class 1 obesity, and relevant medical history of COVID-19 approximately 2 months prior vaccination, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Eclampsia, and the unexpected and serious (due to medically significant) event of Major depression. Patient experienced COVID-19 at 7 weeks gestation, with a full recovery, and was vaccinated for SARS-CoV-2 with mRNA-1273 vaccine at 15+1 and 19+1 weeks. Her only medications were prenatal vitamins with iron and low-dose aspirin for preeclampsia prevention. At 29+5 weeks she developed a productive cough. She presented to urgent care, where vital signs were stable, and SARS-CoV-2 NAAT resulted positive. She was prescribed guaifenesin/codeine for severe cough and began taking additional vitamins (C, D3, zinc). Symptoms completely resolved. At 38+4 weeks gestation, patient presented to the clinic with a headache unrelieved by acetaminophen and hypertension, diagnosing preeclampsia. Patient underwent a cesarean delivery under general anesthesia, and gave birth to a healthy female neonate with Apgar 8/9. Symptoms improved with delivery and mother and infant were discharged on postoperative day 3. One week postpartum, she experienced hypertension, severe headache and visual disturbances followed by an eclamptic seizure. She was admitted to hospital and IV magnesium sulfate was initiated and maintained for 24 hours. A head CT was unremarkable. She was discharged after 2 days with normal blood pressures. At 6 weeks postpartum patient was diagnosed with major depressive disorder (score of 16 on Edinburgh Postnatal Depression Scale) and was started on sertraline 25 mg/day. At the 2-month follow-up, symptoms were resolving. Advanced maternal age, obesity and previous COVID-19, could be contributory factors for Eclampsia and Preeclampsia. Pregnancy complicated by 2 confirmed episodes of COVID-19, eclampsia, and isolation from family and friends could be contributory factors for Major depression. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.