Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure before pregnancy, SARS-CoV-2 test
Clinical narrative: Maternal exposure before pregnancy; COVID 19; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (COVID 19) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date. In May 2022, the patient experienced COVID-19 (COVID 19). On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). At the time of the report, COVID-19 (COVID 19) outcome was unknown and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.   No treatment medication was reported. Patient did not have any allergies. Patient did not receive any other vaccine prior to Moderna vaccine. Patient did not have any chronic or acute illness at the time of vaccination. Patient received 1st booster dose.  Company comment-This spontaneous case concerns a pregnant female patient aged 30 years with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 (with positive SARS-CoV-2 test)  that occurred approximately four and half months after third dose (first booster) of mRNA-1273 vaccination in covid-19 vaccination series. Additionally Maternal exposure before pregnancy was noted. Patient had received 1st and 2nd dose of same vaccine at an interval of 48 days (inappropriate schedule of product administration) followed by 1st booster 7 months later. Gestation period at exposure and last menstrual period not provided. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-643742, MOD-2022-643584, MOD-2022-643584 (Patient Link).; Sender's Comments: This spontaneous case concerns a pregnant female patient aged 30 years with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 (with positive SARS-CoV-2 test)  that occurred approximately four and half months after third dose (first booster) of mRNA-1273 vaccination in covid-19 vaccination series. Additionally Maternal exposure before pregnancy was noted. Patient had received 1st and 2nd dose of same vaccine at an interval of 48 days (inappropriate schedule of product administration) followed by 1st booster 7 months later. Gestation period at exposure and last menstrual period not provided. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.