Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/Rebound testing positive for Covid about a week after finishing Paxlovid prescription; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/Rebound testing positive for Covid about a week after finishing Paxlovid prescription) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unknown drug allergy). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 11-Jan-2022 to an unknown date and EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) from 19-Jan-2022 to an unknown date for an unknown indication.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021 at 12:00 PM, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19/Rebound testing positive for Covid about a week after finishing Paxlovid prescription). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 06-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/Rebound testing positive for Covid about a week after finishing Paxlovid prescription) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient received 3 consecutive doses of m RNA-1273 vaccine. The last dose from that series was given approximately 6 months before paxlovid treatment was started. About a week after finishing paxlovid prescription, rebound testing positive for COVID occurred. Device Date reported 25-May-2022.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with a concomitant medication of descovy and no other relevant medical conditions reported, who experienced an unexpected, non-serious COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 in relation to the 3rd dose of mRNA-1273 vaccine cannot be determined with an unknown event onset date. Patient received 3 consecutive doses of mRNA-1273 vaccine, and the last dose from that series was given approximately 6 months before a 5-day paxlovid treatment was started. About a week after completing the full course of paxlovid treatment, patient reported a rebound positive test with COVID-19. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. Additionally, the concomitant medication of descovy is suggestive of an underlying immunodeficiency status that high likely predisposes the patient to breakthrough COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with a concomitant medication of descovy and no other relevant medical conditions reported, who experienced an unexpected, non-serious COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 in relation to the 3rd dose of mRNA-1273 vaccine cannot be determined with an unknown event onset date. Patient received 3 consecutive doses of mRNA-1273 vaccine, and the last dose from that series was given approximately 6 months before a 5-day paxlovid treatment was started. About a week after completing the full course of paxlovid treatment, patient reported a rebound positive test with COVID-19. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. Additionally, the concomitant medication of descovy is suggestive of an underlying immunodeficiency status that high likely predisposes the patient to breakthrough COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.