Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Maternal exposure during pregnancy; Pharmacist reports that due to some communication gap a patient was inadvertently administered the bivalent vaccine instead of the monovalent vaccine for their 1st primary dose; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), WRONG PRODUCT ADMINISTERED (Pharmacist reports that due to some communication gap a patient was inadvertently administered the bivalent vaccine instead of the monovalent vaccine for their 1st primary dose) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) from 02-Feb-2023 to an unknown date for an unknown indication.    On 02-Feb-2023, 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 02-Feb-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and WRONG PRODUCT ADMINISTERED (Pharmacist reports that due to some communication gap a patient was inadvertently administered the bivalent vaccine instead of the monovalent vaccine for their 1st primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 02-Feb-2023, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reports that due to some communication gap a patient was inadvertently administered the bivalent vaccine instead of the monovalent vaccine for their 1st primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and WRONG PRODUCT ADMINISTERED (Pharmacist reports that due to some communication gap a patient was inadvertently administered the bivalent vaccine instead of the monovalent vaccine for their 1st primary dose).    Treatment medications were not reported.  Patient was on last trimester of pregnancy. Reporter was unaware of the LMP and EDD.  Company comment: This is a non-serious spontaneous case of maternal exposure during pregnancy in the third trimester of gestation, with no associated adverse events, for this 27-year-old female patient  who received mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5) as the first dose of the COVID-19 vaccination schedule (wrong vaccine administered). Pharmacist reported that, due to some communication gap, the patient was inadvertently administered the bivalent vaccine instead of the monovalent vaccine for the 1st primary dose. Influenza vaccine was also administered on the same day. Details regarding medical history, last menstrual period, estimated date of delivery, course and outcome of pregnancy were not provided. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.