Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound COVID-19 Continue to rest positive with milder symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID-19 Continue to rest positive with milder symptoms) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 010A21A and 042L20A) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concomitant products included LOSARTAN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022 at 11:00 AM, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound COVID-19 Continue to rest positive with milder symptoms). At the time of the report, COVID-19 (Rebound COVID-19 Continue to rest positive with milder symptoms) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: positive (Positive) COVID-19 Continue to rest positive.         Company comment:  This spontaneous case concerns a 75-year-old female patient, with no reported medical history, who experienced unexpected, non-serious of COVID-19, approximately 7 months after receiving mRNA-1273 vaccine as a third dose. Dose 1 and Dose 2 were given with a 30-day interval and the third dose was given approximately 8 months after completing the primary series.  Interchange of vaccine products is noted in this case. The patient also reported previously receiving fourth dose of Tozinameran, approximately 6 months after receiving the third dose of mRNA-1273 vaccine.  Information regarding previous doses of Tozinameran is not available in this report. The patient experienced COVID-19 and took a 5-day course of Nirmatrelvir-Ritonavir (Paxlovid).  9 days after the onset of symptoms, the patient remain to test positive with milder symptoms. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old female patient, with no reported medical history, who experienced unexpected, non-serious AESI of COVID-19, approximately 7 months after receiving mRNA-1273 vaccine as a third dose. Dose 1 and Dose 2 were given with a 30-day interval and the third dose was given approximately 8 months after completing the primary series.  Interchange of vaccine products is noted in this case. The patient also reported previously receiving fourth dose of Tozinameran, approximately 6 months after receiving the third dose of mRNA-1273 vaccine.  Information regarding previous doses of Tozinameran is not available in this report. The patient experienced COVID-19 and took a 5-day course of Nirmatrelvir-Ritonavir (Paxlovid).  9 days after the onset of symptoms, the patient remain to test positive with milder symptoms.      The outcome of the event was unknown.    The benefit-risk relationship of mRNA-1273 is not affected by this report.