Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Cold-l ke symptoms returned a week after testing negative after Paxlovid treatment. Tested positive then on two antigen tests; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Cold-l ke symptoms returned a week after testing negative after Paxlovid treatment. Tested positive then on two antigen tests) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 012F21A, OT 010M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Drug allergy (Sulfa).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient experienced COVID-19 (Cold-l ke symptoms returned a week after testing negative after Paxlovid treatment. Tested positive then on two antigen tests). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Cold-l ke symptoms returned a week after testing negative after Paxlovid treatment. Tested positive then on two antigen tests) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In 2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication were reported. Device Date :26May2022  Company comment: This is a spontaneous case concerning a 66-year-old, female patient with no relevant medical history and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days for the first and second dose. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the fourth dose of mRNA-1273 vaccine. The event was described as, on unknown date patient experienced Covid-19. Approximately 37 days after the fourth dose of mRNA-1273 vaccine patient was treated with Nirmatrelvir + Ritonavir (Paxlovid) for Covid-19. On unknown date patient was tested negative. Approximately 8 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient cold like symptoms reoccurred after testing negative. On unknown date patient was tested positive on two antigen test. No other information surrounding the event was reported. The outcome of the event was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 66-year-old, female patient with no relevant medical history and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days for the first and second dose. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the fourth dose of mRNA-1273 vaccine. The event was described as, on unknown date patient experienced Covid-19. Approximately 37 days after the fourth dose of mRNA-1273 vaccine patient was treated with Nirmatrelvir + Ritonavir (Paxlovid) for Covid-19. On unknown date patient was tested negative. Approximately 8 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient cold like symptoms reoccurred after testing negative. On unknown date patient was tested positive on two antigen test. No other information surrounding the event was reported. The outcome of the event was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.