Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.; Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.) and COVID-19 (Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21a, 001B21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Drug allergy (Allergy was reported to unknown past drug).   On 13-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021 at 9:45 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.) and COVID-19 (Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-May-2022 to 06-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.) outcome was unknown and COVID-19 (Paxlovid given for Treatment of COVID-19 on 1-may-2022/Rebound of Covid symptoms five days after finishing paxlovid. Sore throat, congestion, fatigue.Strong positive test on antigen.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Strong positive test on antigen.         Concomitant medication included 365 whole foods market (active drug substance name as 365 Age 50 plus Multivitamin) on 17-Apr-2022.  The patient was taking other medications/products within two weeks of starting COVID-19 treatment. The patient experienced rebound of Covid symptoms five days after finishing Paxlovid (11-May-2022 08:30). Sore throat, congestion, fatigue. Symptoms still present three days after rebound event. Strong positive test on antigen.  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 on an unknown date after receiving a dose of mRNA-1273 Vaccine, 3 doses of the Moderna COVID-19 vaccine were given, the first and second dose had an interval of 26 days, and the third dose had an interval of approximately 7 months from the second dose. SARS-CoV-2 test yielded positive results, the patient was treated with Nirmatrelvir and Ritonavir, no other clinical or treatment details were given. It was reported that the outcome of the event Drug Ineffective was unknown while the event COVID-19 outcome was resolving. 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 on an unknown date after receiving a dose of mRNA-1273 Vaccine, 3 doses of the Moderna COVID-19 vaccine were given, the first and second dose had an interval of 26 days, and the third dose had an interval of approximately 7 months from the second dose. SARS-CoV-2 test yielded positive results, the patient was treated with Nirmatrelvir and Ritonavir, no other clinical or treatment details were given. It was reported that the outcome of the event Drug Ineffective was unknown while the event COVID-19 outcome was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.