Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient took Paxlovid for COVID-19 treatment; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient took Paxlovid for COVID-19 treatment) and DRUG INEFFECTIVE (Lack of drug effect) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048c21a, 029a21a and 041lz0a) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea and Drug allergy (unknown drug). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) from 23-May-2019 to 09-May-2022 for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, 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 COVID-19 (Patient took Paxlovid for COVID-19 treatment) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-Apr-2022 to 05-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient took Paxlovid for COVID-19 treatment) was resolving and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: positive (Positive) Three days later started testing positive for 5 days. In May 2022, SARS-CoV-2 test: negative (Negative) tested negative on rapid tests.           Patient took Paxlovid for COVID-19 treatment as directed for 5 days, after which she tested negative on rapid tests. Three days later, on 09-May-2022, the patient started testing positive again and her symptoms came back. The patient had the symptoms of a mild cold. Patient tested positive for 5 days and then began testing negative again.  Company Comment: This is a spontaneous case concerning a 69-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 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. As reported, the patient took Paxlovid for COVID-19 treatment for 5 days, after which she tested negative on rapid tests. Three days later, the patient started testing positive again and her symptoms came back. Patient tested positive for 5 days and then began testing negative again. 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 69-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 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. As reported, the patient took Paxlovid for COVID-19 treatment for 5 days, after which she tested negative on rapid tests. Three days later, the patient started testing positive again and her symptoms came back. Patient tested positive for 5 days and then began testing negative again. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.