Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Premature delivery, Product dose omission issue
Clinical narrative: Baby was born at 35 weeks.; Mother did not receive 2nd dose of primary series vaccine; Mother was administered first dose of primary series in April 2022, became pregnant in June 2022; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PREMATURE DELIVERY (Baby was born at 35 weeks.), PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine) and MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 001m21a) for COVID-19 prophylaxis.     No Medical History information was reported.   In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In June 2022, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022). On an unknown date, the patient experienced PREMATURE DELIVERY (Baby was born at 35 weeks.) and PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. In June 2022, MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022) had resolved. At the time of the report, PREMATURE DELIVERY (Baby was born at 35 weeks.) and PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine) had resolved.     mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.  It was reported that patient administered first dose of primary series in April 2022, became pregnant in June 2022. Patient did not receive 2nd dose of primary series vaccine. Baby was born at 35 weeks.  Company Comment: This is a spontaneous case concerning a 33 year-old, female patient with maternal exposure before pregnancy and no reported medical history, who experienced the non-serious unexpected, event of premature delivery, which occurred after the first dose of mRNA-1273 vaccine. It was reported that the patient became pregnant approximately 2 months after vaccination. The patient did not receive a second dose of primary series, thus Product dose omission issue was considered as an additional event. Baby was born at 35 weeks. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2023: Live follow up was received by safety on 30-Mar-2023 contains significant information: Event was added, description as reported and description to be coded, event LLT were updated and route of administration of suspect product was added.