Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Pregnant patient received a bivalent booster dose as a first dose of the Moderna COVID19 vaccine; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pregnant patient received a bivalent booster dose as a first dose of the Moderna COVID19 vaccine), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pregnant patient received a bivalent booster dose as a first dose of the Moderna COVID19 vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 06-Oct-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (Pregnant patient received a bivalent booster dose as a first dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pregnant patient received a bivalent booster dose as a first dose of the Moderna COVID19 vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    No concomitant and treatment medications were reported.  Pregnant patient received a bivalent booster dose as a first dose of the Moderna COVID19 vaccine.  Company comment: This spontaneous case concerns a 22-year-old female patient, with no medical history reported, who experienced maternal exposure during pregnancy with no adverse events associated, after a booster dose of mRNA-1273.222 vaccine (no information about previous vaccination schedule was provided). Gestational age, last menstrual period and estimated date of delivery were not reported. Pregnancy outcome not available. No further clinical information was provided for medical reviewing. Additionally, wrong product administrated was considered in the case since patient received a bivalent booster dose as a first dose. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 22-year-old female patient, with no medical history reported, who experienced maternal exposure during pregnancy with no adverse events associated, after a booster dose of mRNA-1273.222 vaccine (no information about previous vaccination schedule was provided). Gestational age, last menstrual period and estimated date of delivery were not reported. Pregnancy outcome not available. No further clinical information was provided for medical reviewing. Additionally, wrong product administrated was considered in the case since patient received a bivalent booster dose as a first dose. The benefit-risk relationship of the mRNA-1273.222 is not affected by this report.