Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy, Pregnancy test, Product administered to patient of inappropriate age
Clinical narrative: Moderna Vaccine under age 18; Inappropriate schedule of vaccine administered; Maternal exposure during pregnancy.; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine under age 18), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy.) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Mar-2021 and the estimated date of delivery was 24-Dec-2021. On 19-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine under age 18), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 19-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy.) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine under age 18) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Treatment information was not provided  This case concerns a 17-year-old female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs. The patient received the first dose of mRNA-1273 at approximately 21 weeks of pregnancy, and second dose at approximately 27 weeks. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 COVID-19 Vaccine in not affected by this report   This case was linked to MOD-2021-283972 (Patient Link). Sender's Comments: This case concerns a 17-year-old female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs. The patient received the first dose of mRNA-1273 at approximately 21 weeks of pregnancy, and second dose at approximately 27 weeks. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 COVID-19 Vaccine in not affected by this report