Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: "Yuky" feeling; COVID-19 virus test positive; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("Yuky" feeling), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and COVID-19 (COVID-19 virus test positive) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Oct-2021. On 06-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced FEELING ABNORMAL ("Yuky" feeling) and COVID-19 (COVID-19 virus test positive). On 06-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, FEELING ABNORMAL ("Yuky" feeling) and COVID-19 (COVID-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive covid-19 test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company Comment: This spontaneous report concerns a 28 year old female patient with no relevant medical history who was exposed to mRNA-1273 vaccine during pregnancy. The patient received both the doses of vaccine (first and second) at unknown weeks of gestation. The report states that the patient tested positive for COVID-19 (non-serious unexpected AESI) after receiving both doses of mRNA-1273 vaccine. In addition, the patient experienced sore arm (non-serious) after the first dose, and an abnormal feeling (non-serious) after the second dose of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-252852 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up document received, contains non-significant information including primary reporter's email address. Changes from initial version included removal of event, dose 1 information, updated start date, stop date and outcome of event; Sender's Comments: This spontaneous report concerns a 28 year old female patient with no relevant medical history who was exposed to mRNA-1273 vaccine during pregnancy. The patient received both the doses of vaccine (first and second) at unknown weeks of gestation. The report states that the patient tested positive for COVID-19 (non-serious unexpected AESI) after receiving both doses of mRNA-1273 vaccine. In addition, the patient experienced sore arm (non-serious) after the first dose, and an abnormal feeling (non-serious) after the second dose of vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.