Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: I woke up on may 23rd with Covid symptoms and tested positive again on a home test; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (I woke up on may 23rd with Covid symptoms and tested positive again on a home test) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 016M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant, Ventricular tachycardia, Mitral valve prolapse and Allergy. Concomitant products included METOPROLOL, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), SERTRALINE HYDROCHLORIDE (ZOLOFT), IRON and VITAMIN D NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Sep-2021 and the estimated date of delivery was 01-Jul-2022. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 13-May-2022, the patient experienced COVID-19 (I woke up on may 23rd with Covid symptoms and tested positive again on a home test). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2021 to 18-May-2021 for COVID-19 prophylaxis, at an unspecified dose and frequency. On 16-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, COVID-19 (I woke up on may 23rd with Covid symptoms and tested positive again on a home test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: negative (Negative) tested negative on may 18th after 5 days of medication therapy. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive on home test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient race given. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine  Company Comment: This is a spontaneous case concerning a 27-year-old female patient currently pregnant, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative after completing the treatment. 5 days after the negative test, COVID symptoms recurred and tested positive for COVID. The event had not resolved at the time of the report. Maternal exposure during pregnancy was also reported as an additional event as the patient received the third dose of mRNA-1273 at approximately 12 weeks of gestation. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 27-year-old female patient currently pregnant, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative after completing the treatment. 5 days after the negative test, COVID symptoms recurred and tested positive for COVID. The event had not resolved at the time of the report. Maternal exposure during pregnancy was also reported as an additional event as the patient received the third dose of mRNA-1273 at approximately 12 weeks of gestation. The benefit-risk relationship of mRNA-1273 is not affected by this report.