Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis (Mild well controlled) and Allergy NOS. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Patient took unknown (active substances: Hydroxychloroquine, Methotrexate) drug as concomitant medication. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Patient had Covid reinfection after testing negative for days after Paxlovid. Device Date: 30May2022. Company Comment: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 (reported as Covid reinfection after testing negative for days after) which occurred approximately 2 months after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 5 days and had COVID reinfection after testing negative for days after Paxlovid. The event of COVID-19 is in relationship with the treatment drug Paxlovid based on start of treatment date and onset date of event. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 (reported as Covid reinfection after testing negative for days after) which occurred approximately 2 months after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 5 days and had COVID reinfection after testing negative for days after Paxlovid. The event of COVID-19 is in relationship with the treatment drug Paxlovid based on start of treatment date and onset date of event. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.