Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during breast feeding, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive on rapid antigen 8-9-22. Tested negative on PCR 8-1-22 and 8-5-22. Have continued to experience fatigue but all other symptoms are gone. Also breastfed 2 year old when taking Paxlovid) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Asthma and Overweight. Concomitant products included LAMOTRIGINE (LAMICTAL), IBUPROFEN (MOTRIN [IBUPROFEN]) and PARACETAMOL (TYLENOL) for an unknown indication. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 09-Aug-2022, the patient experienced COVID-19 (Tested positive on rapid antigen 8-9-22. Tested negative on PCR 8-1-22 and 8-5-22. Have continued to experience fatigue but all other symptoms are gone. Also breastfed 2 year old when taking Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 26-Jul-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 11-Nov-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, COVID-19 (Tested positive on rapid antigen 8-9-22. Tested negative on PCR 8-1-22 and 8-5-22. Have continued to experience fatigue but all other symptoms are gone. Also breastfed 2 year old when taking Paxlovid) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: (Negative) Negative. On 05-Aug-2022, SARS-CoV-2 test: (Negative) Negative. On 09-Aug-2022, SARS-CoV-2 test: (Positive) Positive. End date for Moderna was reported as 11-Nov-2021. Stop date for Paxlovid was reported as 09-Jul-2022. Patient experienced allergy for unknown drug. Patient continued to experience fatigue but all other symptoms were gone. Patient was breastfeeding 2 year old when taking Paxlovid. Company comment: This spontaneous case concerns a female patient of unspecified age with maternal exposure during breast feeding and no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19 that occurred approximately 10 months after the third dose mRNA-1273 vaccination. Maternal exposure during breast feeding was reported as additional event. The event occurred 13 days after the start of NIRMATRELVIR, RITONAVIR (PAXLOVID). SARS-CoV-2 test was negative before and positive after the PAXLOVID as on 09-Aug-2022. The Clinical course was not provided, and the event COVID-19 was resolving. 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. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a female patient of unspecified age with maternal exposure during breast feeding and no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19 that occurred approximately 10 months after the third dose mRNA-1273 vaccination. Maternal exposure during breast feeding was reported as additional event. The event occurred 13 days after the start of NIRMATRELVIR, RITONAVIR (PAXLOVID). SARS-CoV-2 test was negative before and positive after the PAXLOVID as on 09-Aug-2022. The Clinical course was not provided, and the event COVID-19 was resolving. 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.