Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I originally experienced symptoms and tested positive on 05/18/2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I originally experienced symptoms and tested positive on 05/18/2022) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Multiple Autoimmune Syndrome), Asthma, Overweight and Drug allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SPIRONOLACTONE, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, METFORMIN HYDROCHLORIDE (XIGDUO), TOPIRAMATE (TROKENDI), MONTELUKAST and PROPRANOLOL for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced COVID-19 (I originally experienced symptoms and tested positive on 05/18/2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I originally experienced symptoms and tested positive on 05/18/2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive for COVID.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  After completing a full course of Paxlovid on 23-May-2022, the patient had a return of symptoms. On testing with repeated rapid antigen tests on 25-May-2022, the patient was positive for COVID at time of report. Device Date : 26-May-2022.  Company Comment:  This is a spontaneous case concerning a 45-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine as fourth COVID-19 vaccination (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since vaccination date was not provided. Initially, patient experienced unspecified symptoms and was tested positive for COVID-19. Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, the patient reported return of symptoms and was tested positive in Rapid Antigen COVID-19 tests, two days after completion of treatment. Outcome of the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 45-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine as fourth COVID-19 vaccination (no information disclosed on previous COVID-19 vaccinations). Latency cannot be properly assessed since vaccination date was not provided. Initially, patient experienced unspecified symptoms and was tested positive for COVID-19. Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, the patient reported return of symptoms and was tested positive in Rapid Antigen COVID-19 tests, two days after completion of treatment. Outcome of the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.