Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan, Vaccination site bruising, Vaccination site pain
Clinical narrative: Bruising and sore arm; Bruising and sore arm; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE BRUISING (Bruising and sore arm) and VACCINATION SITE PAIN (Bruising and sore arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Moderate, irregular consumption) on 27-Sep-2020 and Smoker (6 years ago). Concomitant products included PARACETAMOL (TYLENOL) for Headache, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Aug-2020 and the estimated date of delivery was 05-Jun-2021. On 26-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 27-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruising and sore arm) and VACCINATION SITE PAIN (Bruising and sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 26-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruising and sore arm) and VACCINATION SITE PAIN (Bruising and sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2020, Pregnancy test: positive (Positive) Positive. On 06-Jan-2021, Ultrasound scan: positive (Positive) 3rd - The fetus was 1 week behind size compared to actual date..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. On 04-november-2020 genetic testing with normal outcome.  Company Comment: This is a case of product exposure during pregnancy with AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: ADR form received. The reported events were updated. Added patient demographics. Added Medical history details. Updated concomitant medications. The patient reported she only experienced bruise and sore arm. No contusion was experienced.; Sender's Comments: This is a case of product exposure during pregnancy with AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.