Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gestational hypertension, Interchange of vaccine products, Maternal exposure during pregnancy, Premature labour, Ultrasound antenatal screen
Clinical narrative: Preterm labor symptoms; High blood pressure of pregnancy; Maternal exposure during pregnancy; Interchange of vaccine products; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of GESTATIONAL HYPERTENSION (High blood pressure of pregnancy), PREMATURE LABOUR (Preterm labor symptoms) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient (gravida 8, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 immunisation.    The patient's past medical history included Miscarriage (Three past pregnancies), E-cigarette smoker (Monthly/before this pregnancy), Recreational drug use (Less than monthly/ before this pregnancy) and Elective abortion (Three past pregnancies). Concurrent medical conditions included Multigravida (Eight past pregnancies / two live babies), Anxiety, Bipolar disorder, Depression, Tobacco user (10 or fewer cigarettes per day during this pregnancy), Alcohol use (Once per week during the first three months of pregnancy) and Migraine. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) from 07-Jul-2021 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 20-May-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) .5 milliliter. On 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Mar-2022. On 15-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion hospitalization) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 04-Jan-2022, the patient experienced GESTATIONAL HYPERTENSION (High blood pressure of pregnancy) (seriousness criterion hospitalization). On 09-Feb-2022, the patient experienced PREMATURE LABOUR (Preterm labor symptoms) (seriousness criterion hospitalization). On 15-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. At the time of the report, GESTATIONAL HYPERTENSION (High blood pressure of pregnancy) had not resolved and PREMATURE LABOUR (Preterm labor symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, Ultrasound antenatal screen: unknown Unknown.         Patient received JANSSEN COVID-19 VACCINE of dose 1. Drug start and last period was 229 days. The patients experienced maternal exposure during pregnancy. On 20-May-2021, the patient experienced sore arm, redness at the injection site. On 21-May-2021, she was experienced chills and muscle pain.On 22-May-2021, the patient experienced join pain, fatigue and fever. The patient recovered from chills, fever and muscle pain on 20-Jun-2021, joint pain and sore arm on 27-May-2021and redness at injection site on 16-Jun-2021 and outcome of fatigue and maternal exposure during pregnancy not reported.  Patient received Moderna Covid-19 vaccine (dose 2 in series, booster). The patient was diagnosed with high blood pressure of pregnancy on 04-Jan-2022.Blood pressure was being monitored weekly and steroids were introduced as a treatment. And iron supplements were reported as a concomitant product.  Company comment: This spontaneous case concerns a 35-year-old female patient (gravida 8, para 2) with a history of Miscarriage (Three past pregnancies), E-cigarette smoker (Monthly/before this pregnancy), Recreational drug use (Less than monthly/ before this pregnancy) and Elective abortion (Three past pregnancies) and Concurrent medical conditions of Multigravida (Eight past pregnancies / two live babies), Anxiety, Depression, Tobacco user (10 or fewer cigarettes per day during this pregnancy) and Alcohol use (Once per week during the first three months of pregnancy), who experienced the unexpected serious events of Gestational hypertension and Premature labour (Preterm labor symptoms). The event Gestational hypertension occurred 20 days after, and the event Premature labour occurred 56 days after a dose of mRNA-1273 vaccine administration. Maternal exposure during pregnancy is also noted in this case. The patient's last menstrual period was on an unknown date and the estimated date of delivery was march.  Its reported the patient was diagnosed with high blood pressure of pregnancy on 04-Jan-2022. Blood pressure was being monitored weekly and steroids were introduced as a treatment. The patient was noted to have received a dose from JANSSEN COVID-19 VACCINE) 6 months 25 days prior to current vaccination with mRNA1273 (Interchange of vaccine products). Patient's medical history of E-cigarette smoking, Recreational drug use, Tobacco usage and alcohol usage are risk factors for Gestational hypertension and history of Miscarriage, Elective abortion, usage of tobacco and alcohol, E-cigarette smoking, Recreational drug use, Anxiety, depression and hypertension could be confounding for Premature labour (Preterm labor symptoms). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 35-year-old female patient (gravida 8, para 2) with a history of Miscarriage (Three past pregnancies), E-cigarette smoker (Monthly/before this pregnancy), Recreational drug use (Less than monthly/ before this pregnancy) and Elective abortion (Three past pregnancies) and Concurrent medical conditions of Multigravida (Eight past pregnancies / two live babies), Anxiety, Depression, Tobacco user (10 or fewer cigarettes per day during this pregnancy) and Alcohol use (Once per week during the first three months of pregnancy), who experienced the unexpected serious events of Gestational hypertension and Premature labour (Preterm labor symptoms). The event Gestational hypertension occurred 20 days after, and the event Premature labour occurred 56 days after a dose of mRNA-1273 vaccine administration. Maternal exposure during pregnancy is also noted in this case. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Mar-2022.  Its reported the patient was diagnosed with high blood pressure of pregnancy on 04-Jan-2022. Blood pressure was being monitored weekly and steroids were introduced as a treatment. The patient was noted to have received a dose from JANSSEN COVID-19 VACCINE) 6 months 25 days prior to current vaccination with mRNA1273 (Interchange of vaccine products). Patient's medical history of E-cigarette smoking, Recreational drug use, Tobacco usage and alcohol usage are risk factors for Gestational hypertension and history of Miscarriage, Elective abortion, usage of tobacco and alcohol, E-cigarette smoking, Recreational drug use, Anxiety, depression and hypertension could be confounding for Premature labour (Preterm labor symptoms). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.