Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: 1st Dose on 15-Jan-2021 & 2nd Dose on 27-Feb-2021; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Jan-2021 & 2nd Dose on 27-Feb-2021) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Jan-2021 & 2nd Dose on 27-Feb-2021). On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Jan-2021 & 2nd Dose on 27-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning  a  57-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Inappropriate schedule of product administration, Maternal exposure during pregnancy. The event Maternal exposure during pregnancy occurred on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. While the event Inappropriate schedule of product administration occurred on an unknown date. It was reported that patient received the second dose of mRNA-1273 COVID 19 Vaccine on February 27, 2021. The events were reported as outcome unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-574007 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  57-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Inappropriate schedule of product administration, Maternal exposure during pregnancy. The event Maternal exposure during pregnancy occurred on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. While the event Inappropriate schedule of product administration occurred on an unknown date. It was reported that patient received the second dose of mRNA-1273 COVID 19 Vaccine on February 27, 2021. The events were reported as outcome unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.