Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event, Product dose omission issue
Clinical narrative: product dose omission; No adverse event; her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant), PRODUCT DOSE OMISSION ISSUE (product dose omission) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On 06-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. The patient's last menstrual period was in November 2022 and the estimated date of delivery was on an unknown date. On 06-Apr-2023, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (product dose omission) and NO ADVERSE EVENT (No adverse event). The patient received mRNA-1273 (Spikevax) beginning around the  fourth month of the pregnancy.  On 06-Apr-2023, MATERNAL EXPOSURE DURING PREGNANCY (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (product dose omission) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (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 (her first Moderna Covid -19 vaccine on April 6, 2023 patient received in her right arm lot number patient is 4 months pregnant) and PRODUCT DOSE OMISSION ISSUE (product dose omission).    No concomitant and treatment medications were reported. Company comment: This spontaneous case concerns a 29-year-old female patient, with no medical history reported, who experienced maternal exposure during pregnancy after being vaccinated with mRNA-1273 while in 4th and 5th month of pregnancy gestation period at exposure. There was no adverse event in the case. Details on delivery and newborn status are not yet available. The vaccination included 2 doses of mRNA-1273 vaccination which were two first doses in the COVID-19 vaccination schedule; it is not clear how many days apart the doses were administered and if in the same doses. Outcome of pregnancy is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-722441 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722441:Bivalent suspect case