Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: special situation of pregnancy applies to me; minor soreness at the injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (special situation of pregnancy applies to me) and VACCINATION SITE PAIN (minor soreness at the injection site) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink/week) on 04-Jul-2021. Concurrent medical conditions included Drug hypersensitivity (Allergy to sulfa drugs) and Migraine with aura (occasional frequency (1 every few months) has not changed.) since 01-Jan-1998. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2019 to an unknown date for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 30-Jun-2021 and the estimated date of delivery was 08-Apr-2022. On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (special situation of pregnancy applies to me) and VACCINATION SITE PAIN (minor soreness at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (special situation of pregnancy applies to me) and VACCINATION SITE PAIN (minor soreness at the injection site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.  This case involves a 36-year-old female with a medical history of alcohol use once per week and concurrent medical conditions of drug hypersensitivity and migraine with aura who experienced the non-serious listed adverse events of minor soreness at the injection site after receiving her first vaccination and of fever, fatigue and headache after her second vaccination. 6 months after her second vaccination, the subject received a positive pregnancy test result on 30 July 2021. This is a case of maternal exposure before pregnancy. No adverse events concerning the pregnancy have occurred, yet. No positive re-challenge has occurred.  The benefit-risk relationship of mRNA-1273 has not been affected by this report.   This case was linked to MOD-2021-345917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Significant: HCP contact details added, patient demographic details added, patient pregnancy details added (LMP date, pregnancy test, estimated due date), medical history added, past drug history added. Covid vaccines details for both the doses updated. Concomitant drug was added. On 07-Oct-2021: minor soreness at the injection site, event was provided.; Sender's Comments: This case involves a 36-year-old female with a medical history of alcohol use once per week and concurrent medical conditions of drug hypersensitivity and migraine with aura who experienced the non-serious listed adverse events of minor soreness at the injection site after receiving her first vaccination and of fever, fatigue and headache after her second vaccination. 6 months after her second vaccination, the subject received a positive pregnancy test result on 30 July 2021. This is a case of maternal exposure before pregnancy. No adverse events concerning the pregnancy have occurred, yet. No positive re-challenge has occurred.  The benefit-risk relationship of mRNA-1273 has not been affected by this report.