Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound symptoms of Covid after stopping medication Paxlovid/Positive test for Covid after stopping medication; Received Moderna Dose 3 on 28-AUG-2021 and experienced Covid recurrence on 17 May 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Rebound symptoms of Covid after stopping medication Paxlovid/Positive test for Covid after stopping medication) and DRUG INEFFECTIVE (Received Moderna Dose 3 on 28-AUG-2021 and experienced Covid recurrence on 17 May 2022) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 80777-0273-15, 013m20A and 04Il20a) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hashimoto's thyroiditis, Drug allergy (Keflex) and Penicillin allergy.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-May-2022 at 8:00 PM, the patient experienced COVID-19 (Rebound symptoms of Covid after stopping medication Paxlovid/Positive test for Covid after stopping medication) and DRUG INEFFECTIVE (Received Moderna Dose 3 on 28-AUG-2021 and experienced Covid recurrence on 17 May 2022). At the time of the report, COVID-19 (Rebound symptoms of Covid after stopping medication Paxlovid/Positive test for Covid after stopping medication) was resolving and DRUG INEFFECTIVE (Received Moderna Dose 3 on 28-AUG-2021 and experienced Covid recurrence on 17 May 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, 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  Patient did not take any other medications or products within 2 weeks of starting COVID-19 treatment. Device date was reported as 18-May-2022  Company comment: This is a spontaneous case concerning a 42-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and unexpected, non-serious event of Drug Ineffective which occurred 8 months 20 days after receiving the third dose of mRNA-1273 vaccine. The event  COVID-19 (Rebound symptoms of Covid after stopping medication Paxlovid/Positive test for Covid after stopping medication) no other clinical or treatment details were given. SARS-CoV-2 test was positive as on 17-May-2022.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 42-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and unexpected, non-serious event of Drug Ineffective which occurred 8 months 20 days after receiving the third dose of mRNA-1273 vaccine. The event  COVID-19 (Rebound symptoms of Covid after stopping medication Paxlovid/Positive test for Covid after stopping medication) no other clinical or treatment details were given. SARS-CoV-2 test was positive as on 17-May-2022.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.