Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: paxlovid rebound, renewal of symptoms and positive test 4-5 days after finishing paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (paxlovid rebound, renewal of symptoms and positive test 4-5 days after finishing paxlovid treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 048B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022 at 9:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (paxlovid rebound, renewal of symptoms and positive test 4-5 days after finishing paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (paxlovid rebound, renewal of symptoms and positive test 4-5 days after finishing paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided.  Patient had Pfizer for treatment of COVID-19. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company comment:  This spontaneous case concerns a patient of unknown age and gender, with no reported medical history who experienced unexpected, non-serious, of COVID-19, approximately 6 months after receiving mRNA-1273 vaccine as a third dose.  The patient's reported primary COVID-19 series is also mRNA-1273 vaccine with the second dose given approximately 7 months before receiving the third dose of the vaccine.  The patient was treated with Nirmatrelvir-Ritonavir (Paxlovid) for 4 days, at unspecified dose and frequency. Three days after completing the 4-day course of Paxlovid, the patient reported rebound, renewal of symptoms and has tested positive on a SARS-CoV-2 test.  The event had not resolved.  The ongoing pandemic remains to be a confounder for the event.  The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history who experienced unexpected, non-serious, AESI of COVID-19, approximately 6 months after receiving mRNA-1273 vaccine as a third dose.  The patient's reported primary COVID-19 series is also mRNA-1273 vaccine with the second dose given approximately 7 months before receiving the third dose of the vaccine.  The patient was treated with Nirmatrelvir-Ritonavir (Paxlovid) for 4 days, at unspecified dose and frequency. Three days after completing the 4-day course of Paxlovid, the patient reported rebound, renewal of symptoms and has tested positive on a SARS-CoV-2 test.  The event had not resolved.  The ongoing pandemic remains to be a confounder for the event.  The benefit-risk relationship of mRNA-1273 is not affected by this report