Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (Tested negative for Covid on 7/11/22 and symptoms resolved after taking Paxlovid. Tested negative daily until 7/16/22 where symptoms returned and I am testing positive for Covid again) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059m21a, 053e21a, 031L20A and 012L20A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Percocet. Past adverse reactions to the above products included Allergy with Percocet. On 15-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022 at 1:00 PM, received fourth 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 an unknown date and the estimated date of delivery was 04-Aug-2022. On 02-Nov-2021 at 1:00 PM, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). In July 2022, the patient experienced COVID-19 (Tested negative for Covid on 7/11/22 and symptoms resolved after taking Paxlovid. Tested negative daily until 7/16/22 where symptoms returned and I am testing positive for Covid again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-Jul-2022 to 11-Jul-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 02-Nov-2021 at 1:00 PM, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, COVID-19 (Tested negative for Covid on 7/11/22 and symptoms resolved after taking Paxlovid. Tested negative daily until 7/16/22 where symptoms returned and I am testing positive for Covid again) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 12-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 13-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 14-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 15-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 16-Jul-2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient tested negative for COVID on 11-Jul-2022 and symptoms resolved after taking Paxlovid. The patient tested negative daily until 16-Jul-2022 where symptoms returned and patient tested positive for COVID again. Company Comment: This spontaneous case concerns a 31-year-old, female patient at 37 weeks age of gestation, who experienced the unexpected, non-serious events of Maternal exposure during pregnancy and an AESI COVID-19 in association with mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 29 days apart. Her first booster dose was given approximately 9 months prior to her due date. A 2nd booster dose was given approximately 6 months later. Paxlovid was given 28 days before her delivery date as a treatment for COVID-19. On the 4th day from Paxlovid start date, symptoms resolved and she tested negative with COVID-19. She tested negative with COVID-19 daily until 5 days later when she retested positive for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement. Sender's Comments: This spontaneous case concerns a 31-year-old, female patient at 37 weeks age of gestation, who experienced the unexpected, non-serious events of Maternal exposure during pregnancy and an AESI COVID-19 in association with mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 29 days apart. Her first booster dose was given approximately 9 months prior to her due date. A 2nd booster dose was given approximately 6 months later. Paxlovid was given 28 days before her delivery date as a treatment for COVID-19. On the 4th day from Paxlovid start date, symptoms resolved and she tested negative with COVID-19. She tested negative with COVID-19 daily until 5 days later when she retested positive for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.