Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Precipitate labour, Pregnancy test, Ultrasound scan
Clinical narrative: rapid delivery; I was pregnant (3rd trimester both covid vaccine doses); This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I was pregnant (3rd trimester both covid vaccine doses)) and PRECIPITATE LABOUR (rapid delivery) in a 34-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovary. Concomitant products included MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE].   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 14-Jun-2021. On 25-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I was pregnant (3rd trimester both covid vaccine doses)). On an unknown date, the patient experienced PRECIPITATE LABOUR (rapid delivery). The vaginal delivery occurred on 16-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 4044 grams (8lbs 15oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Patient delivered a healthy baby on 16-JUN-2021 (two days past due date). On 25-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (I was pregnant (3rd trimester both covid vaccine doses)) had resolved. At the time of the report, PRECIPITATE LABOUR (rapid delivery) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Ultrasound scan: normal (normal) Normal. On 31-Mar-2021, Blood glucose: normal (normal) Normal. On 02-Oct-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  Patient delivered a healthy baby on 16-JUN-2021 (two days past due date).  Company Comment: This case concerns a 34-year-old, female patient with medical history of polycystic ovary, who experienced the non serious events of maternal exposure during pregnancy and precipitate labour. The patient received both vaccine doses at 3rd trimester of pregnancy (28th and 32nd gestational week).  The vaginal delivery occurred on 16-Jun-2021, which was reported as Full-term.Patient delivered a healthy baby on 16-JUN-2021 (two days past due date).  For neonate, the birth weight was 4044 grams (8lbs 15oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.   This case was linked to MOD-2021-357824 (Parent-Child Link).   See case MOD-2021-357824 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant Follow up-Pregnancy outcome form received, event added, child case created; Sender's Comments: This case concerns a 34-year-old, female patient with medical history of polycystic ovary, who experienced the non serious events of maternal exposure during pregnancy and precipitate labour. The patient received both vaccine doses at 3rd trimester of pregnancy (28th and 32nd gestational week).  The vaginal delivery occurred on 16-Jun-2021, which was reported as Full-term.Patient delivered a healthy baby on 16-JUN-2021 (two days past due date).  For neonate, the birth weight was 4044 grams (8lbs 15oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.