Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID 5/23 Negative 5/17, 5/19, 5/20 Paxlovid 5/13-5/17; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Positive for COVID 5/23 Negative 5/17, 5/19, 5/20 Paxlovid 5/13-5/17) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient's past medical history included Prediabetes (Pre diabetes). Concomitant products included METFORMIN for Prediabetes.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for COVID 5/23 Negative 5/17, 5/19, 5/20 Paxlovid 5/13-5/17). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive for COVID 5/23 Negative 5/17, 5/19, 5/20 Paxlovid 5/13-5/17) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on other medications/products within 2 weeks of starting COVID-19 treatment and patient previously received a COVID-19 Vaccine. Patient also reported of no known drug allergies.  Company comment: This is a spontaneous case concerning a 57-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious ADR event of Covid-19. The event occurred approximately 137 days after the first dose of mRNA-1273 vaccine administration. The event was described as, patient took Nirmatrelvir (Paxlovid) for approximately 4 days and tested negative for Covid-19 at the last day of taking Nirmatrelvir (Paxlovid) and for 2 more days. However, approximately 6 days after taking Nirmatrelvir (Paxlovid) patient tested positive for Covid-19. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 57-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious ADR event of Covid-19. The event occurred approximately 137 days after the first dose of mRNA-1273 vaccine administration. The event was described as, patient took Nirmatrelvir (Paxlovid) for approximately 4 days and tested negative for Covid-19 at the last day of taking Nirmatrelvir (Paxlovid) and for 2 more days. However, approximately 6 days after taking Nirmatrelvir (Paxlovid) patient tested positive for Covid-19. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.