Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive again on Binax/Fatigue throughout, recurrence of sore throat, runny nose approximately 8 days after completion of medication; Lack of efficacy; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive again on Binax/Fatigue throughout, recurrence of sore throat, runny nose approximately 8 days after completion of medication) and DRUG INEFFECTIVE (Lack of efficacy) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DULOXETINE HYDROCHLORIDE (BINAX) for an unknown indication.    The patient had no drug allergy. The patient had previously received a COVID-19 vaccine.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-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 started DULOXETINE HYDROCHLORIDE (BINAX) (unknown route) taken for 8 days. On 17-May-2022, the patient experienced COVID-19 (Tested positive again on Binax/Fatigue throughout, recurrence of sore throat, runny nose approximately 8 days after completion of medication) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive again on Binax/Fatigue throughout, recurrence of sore throat, runny nose approximately 8 days after completion of medication) had not resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on Binax after full course.. On 17-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive again on Binax.         No concomitant medication information was reported.  The device date was reported as 17-May-2022.  Company Comment: This is a spontaneous case concerning a 58-year-old male patient 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 6 months after receiving the third dose of mRNA-1273 Vaccine. As reported, patient was being treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 for four days. Patient was tested positive again 8 days after completing the treatment, 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 58-year-old male patient 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 6 months after receiving the third dose of mRNA-1273 Vaccine. As reported, patient was being treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 for four days. Patient was tested positive again 8 days after completing the treatment, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.