Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: Received dose of Moderna from a vial that was opened for 18 hours; Second dose >35 days from first dose; Patient was pregnant at the time of administration; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose of Moderna from a vial that was opened for 18 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >35 days from first dose) and MATERNAL EXPOSURE DURING PREGNANCY (Patient was pregnant at the time of administration) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Oct-2021. On 02-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient was pregnant at the time of administration). On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose of Moderna from a vial that was opened for 18 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >35 days from first dose). On 02-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient was pregnant at the time of administration) had resolved. On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose of Moderna from a vial that was opened for 18 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose >35 days from first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was pregnant at the time of administration, and was getting a cesarean today. No concomitant and treatment medication were reported. Company Comment: This case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy, expired product administered and inappropriate schedule of product administration. The patient received dose of Moderna from a vial that was opened for 18 hours and was pregnant at the time. The patient received the second dose 50 days after first dose. The patient was scheduled to and was get a cesarean, as reported. The benefit-risk relationship of Spikevax in not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Significant Follow-Up received on 26-Oct-2021 contains updated patient initial and Pregnancy status.; Sender's Comments: This case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy, expired product administered and inappropriate schedule of product administration. The patient received dose of Moderna from a vial that was opened for 18 hours and was pregnant at the time. The patient received the second dose 50 days after first dose. The patient was scheduled to and was get a cesarean, as reported. The benefit-risk relationship of Spikevax in not affected by this report.