Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; After taking paxlovid and feeling fine with neg antigen my symptoms rebounded with positive antigen 5 days after completing the course; This spontaneous case was reported by a nurse and describes the occurrence of DRUG INEFFECTIVE (Drug ineffective) and COVID-19 (After taking paxlovid and feeling fine with neg antigen my symptoms rebounded with positive antigen 5 days after completing the course) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O12H21B, O13L20A and O11J20A) for COVID-19 vaccination.  Concurrent medical conditions included Hypertension, Pre-diabetic and Penicillin allergy. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-Apr-2022 to 20-Apr-2022 for COVID-19, METFORMIN and LISINOPRIL for an unknown indication.  On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2022, the patient experienced DRUG INEFFECTIVE (Drug ineffective) and COVID-19 (After taking paxlovid and feeling fine with neg antigen my symptoms rebounded with positive antigen 5 days after completing the course). At the time of the report, DRUG INEFFECTIVE (Drug ineffective) outcome was unknown and COVID-19 (After taking paxlovid and feeling fine with neg antigen my symptoms rebounded with positive antigen 5 days after completing the course) was resolving.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: positive (Positive) positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient received unknown medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. No treatment medication was reported.  Company comment: This is a spontaneous case concerning a 68-year-old female  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than one year after the second dose, and approximately 5 months after the third dose of mRNA-1273 vaccine. Patient describes that after taking paxlovid for COVID-19 treatment and feeling fine her symptoms rebound with positive antigen test 5 days after completing the course. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 68-year-old female  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than one year after the second dose, and approximately 5 months after the third dose of mRNA-1273 vaccine. Patient describes that after taking paxlovid for COVID-19 treatment and feeling fine her symptoms rebound with positive antigen test 5 days after completing the course. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.