Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Amoxicillin. Past adverse reactions to the above products included Allergy with Amoxicillin.    On 03-May-2022 at 1:15 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive (first occurrence).         No Concomitant product use was reported.  It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient started rebound Covid symptoms 2 days after completing the 5 day course. Sneezing, sinus headache and congestion, shortness of breath dry cough. The symptoms got progressively worse, and the patient was still symptomatic 8 days following Paxlovid course completion. Reportedly, the patient's chest doesn't feel good.   The device date was reported as 29-May-2022.  Company Comment:  This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred on the same month after receiving a dose of mRNA-1273 as fourth COVID-19 vaccination (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, two days after completion of Paxlovid treatment, patient reported rebound COVID-19 symptoms, described as sneezing, sinus headache and congestion, shortness of breath, and dry cough. Eight days after Paxlovid treatment, patient reported that her chest doesn't feel good and noted progressive worsening of symptoms. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred on the same month after receiving a dose of mRNA-1273 as fourth COVID-19 vaccination (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, two days after completion of Paxlovid treatment, patient reported rebound COVID-19 symptoms, described as sneezing, sinus headache and congestion, shortness of breath, and dry cough. Eight days after Paxlovid treatment, patient reported that her chest doesn't feel good and noted progressive worsening of symptoms. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.