Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose, Hypertension, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Hypertension; Pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of HYPERTENSION (Hypertension) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 1) who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 029H22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (at home rapid test) on 23-Jul-2022. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (Dose 1, (Batch: 046B21A), Arm) on 13-Apr-2021, Moderna Covid-19 Vaccine (Dose 2, (Batch: 022C21A),  Arm) on 11-May-2021, Moderna Covid-19 Vaccine (Dose 3, (Batch: 027H21B) and  Arm) on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine, Moderna Covid-19 Vaccine and Moderna Covid-19 Vaccine. Concurrent medical conditions included Penicillin allergy.    On 15-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. The patient's last menstrual period was on 28-Oct-2022 and the estimated date of delivery was 31-Jul-2023. On 11-Nov-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 13-Dec-2022, the patient experienced HYPERTENSION (Hypertension). The patient received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) beginning around the  second week of the pregnancy.  At the time of the report, HYPERTENSION (Hypertension) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2022, Pregnancy test: Positive. In May 2023, Blood glucose: 115 mg/dl Glucola- 1 Hour Test.         Concomitant and treatment medications were not reported.  Estimated date of conception was reported as 11-Nov-2022.  Ultrasound was performed on Dec 2022 and Jan 2023 and results were not provided.  Reported that patient was likely conceived before 4th vaccination dose.  Additional race reported.  Company comment:  This spontaneous case concerns a 34  year  old female patient, with no relevant medical history reported, and maternal exposure during pregnancy, who experienced the unexpected, non  serious event of hypertension. The event occurred approximately one month after a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine; fourth dose of her COVID  19 immunization schedule; the patient previously received 3 doses of Moderna COVID  19 vaccine. The patient received the vaccine at approximately 2 weeks of gestation. The outcome of the event was recovered. No further clinical details were provided for medical reviewing. Patient´s pregnancy could be considered as a confounding factor. The benefit-risk relationship of 1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-728532 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728532:Monovaent case