Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy, Pregnancy test
Clinical narrative: spontaneous miscarriage; conceived following second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder, Drug allergy (sulfa), Drug allergy (cephalosporins) and Drug allergy (codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, PREGNANCY (conceived following second dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (spontaneous miscarriage) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29Jan2021 This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder and Drug allergy (sulfa, cephalosporins, codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication.   On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, ABORTION SPONTANEOUS (spontaneous miscarriage) and PREGNANCY (conceived following second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of last menstrual period was 29 Jan 2021.  This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. 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; Sender's Comments: This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. 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