Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid; COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid) and DRUG INEFFECTIVE (COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, the patient experienced COVID-19 (COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid) and DRUG INEFFECTIVE (COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 03-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid) was resolving and DRUG INEFFECTIVE (COVID positive-recent paxlovid tx, completed course and COVID negative, now with recurrent symptoms and repeated positive test, c/f rebound covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 14-May-2022, SARS-CoV-2 test: positive (Positive) retook test positive again Very mild symptoms. On 15-May-2022, SARS-CoV-2 test: positive (Positive) retook test positive again Very mild symptoms. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had symptoms on 01-May-2022, reporter saw patient 03-May-2022, started Paxlovid 03-May-2022 which was finished Sunday morning 08-May-2022. Still had symptoms on 10-May-2022 and 11-May-2022 but improved tested negative x2 (12-May-2022 and 13-May-2022) cough was more. Retook test on 14-May-2022 and on 15-May-2022 result came positive. Very mild symptoms just felt congested, allergy feeling. Would not think patient had COVID if not for recent infection. Feels like typical allergies.  Company Comment: This spontaneous case concerns a 66-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of Drug Ineffective, and adverse event of special interest, COVID-19. The events occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine, the first and second dose had an interval of 28 days, and the third dose had an interval of approximately 8 months from the second dose. As reported, the patient had symptoms on 01-May-2022 and was started with the Paxlovid for 5 days. The patient still had symptoms but improved and tested negative twice, but cough was more pronounced. Retook COVID-19 test on 14-May-2022 and on 15-May-2022 result came positive. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of Drug Ineffective, and adverse event of special interest, COVID-19. The events occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine, the first and second dose had an interval of 28 days, and the third dose had an interval of approximately 8 months from the second dose. As reported, the patient had symptoms on 01-May-2022 and was started with the Paxlovid for 5 days. The patient still had symptoms but improved and tested negative twice, but cough was more pronounced. Retook COVID-19 test on 14-May-2022 and on 15-May-2022 result came positive. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.