Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event, Product administration interrupted
Clinical narrative: This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (1st dose in February of 2022 but no 2nd dose yet), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. In February 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In February 2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (1st dose in February of 2022 but no 2nd dose yet) and NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. In February 2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (1st dose in February of 2022 but no 2nd dose yet) 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 PRODUCT ADMINISTRATION INTERRUPTED (1st dose in February of 2022 but no 2nd dose yet) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). Concomitant and treatment medications was not reported. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, non-serious event of Maternal exposure during pregnancy on the same month of vaccination with a dose of mRNA-1273. Additional event of Product administration interrupted was reported since the patient has not received her second dose. No adverse event was noted. Exact latency of the patient's exposure during pregnancy to vaccination cannot be determined since incomplete details were provided regarding the vaccination date, and no details regarding the last menstrual period, and estimated delivery date was given. The birth type was unknown, and the outcome was reported as Delivered not otherwise specified. The outcome of the event Maternal exposure during pregnancy was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, non-serious event of Maternal exposure during pregnancy on the same month of vaccination with a dose of mRNA-1273. Additional event of Product administration interrupted was reported since the patient has not received her second dose. No adverse event was noted. Exact latency of the patient's exposure during pregnancy to vaccination cannot be determined since incomplete details were provided regarding the vaccination date, and no details regarding the last menstrual period, and estimated delivery date was given. The birth type was unknown, and the outcome was reported as Delivered not otherwise specified. The outcome of the event Maternal exposure during pregnancy was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.