Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 5-day Paxlovid course seemed to be effective producing a negative test on 5/9. Stuffy nose, sneezing began 6-days later on 5/15 producing a positive test 5/17. Lo; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (5-day Paxlovid course seemed to be effective producing a negative test on 5/9. Stuffy nose, sneezing began 6-days later on 5/15 producing a positive test 5/17. Lo) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 018F21A, 024C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022 at 11:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2022, the patient experienced COVID-19 (5-day Paxlovid course seemed to be effective producing a negative test on 5/9. Stuffy nose, sneezing began 6-days later on 5/15 producing a positive test 5/17. Lo). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (5-day Paxlovid course seemed to be effective producing a negative test on 5/9. Stuffy nose, sneezing began 6-days later on 5/15 producing a positive test 5/17. Lo) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected non serious events of Drug Ineffective, and adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the 4th dose of mRNA-1273 Vaccine with an interval of 5 months from the 3rd dose of mRNA-1273 vaccine with an interval of 7 months from the 2nd dose of mRNA-1273 vaccine and with an interval of 28 days from the 1st dose of mRNA-1273 vaccine. It was reported that the patient completed treatment Paxlovid producing a negative result however patient complained of sneezing and stuffy nose after 6 days and a positive test. 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 patient of an unknown age and gender with no reported medical history, who experienced the unexpected non serious events of Drug Ineffective, and adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the 4th dose of mRNA-1273 Vaccine with an interval of 5 months from the 3rd dose of mRNA-1273 vaccine with an interval of 7 months from the 2nd dose of mRNA-1273 vaccine and with an interval of 28 days from the 1st dose of mRNA-1273 vaccine. It was reported that the patient completed treatment Paxlovid producing a negative result however patient complained of sneezing and stuffy nose after 6 days and a positive test. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.