Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Day 3 of relapse and symptoms worsening each day) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis, Arthritis and Drug allergy (Allergy to unspecified drug). Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN D3 and ALENDRONATE SODIUM (FOSAMAX) from 26-Jan-2022 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Day 3 of relapse and symptoms worsening each day). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Day 3 of relapse and symptoms worsening each day) had not resolved. It was also reported that patient took other medications/products within 2 weeks of starting the COVID-19 treatment and previously received a COVID-19 vaccine. Patient had relapsed of all symptoms started 5-6 days after completion of the Paxlovid course. Currently On day 3 of relapse and symptoms worsened each day. Company Comment: This spontaneous case reported by a patient, concerns a 59-year-old female patient with medical history of Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN D3 and ALENDRONATE, received doses of mRNA-1273 Vaccine on 19-Nov,2021, 30-Mar and on 27-Apr-2022 who experienced the unexpected non serious AESI event of Covid-19 infection unknown days after receiving a dose of mRNA-1273 vaccine in the Covid-19 vaccination series. It was reported that the patient was treated with Paxlovid starting on 23-May to 28-May-2022 for Covid-19 treatment. Details of the onset date, lab results and symptoms of this initial Covid-19 infection and its outcome was not reported. Treatment for the event was not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement. Sender's Comments: This spontaneous case reported by a patient, concerns a 59-year-old female patient with medical history of Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN D3 and ALENDRONATE, received doses of mRNA-1273 Vaccine on 19-Nov,2021, 30-Mar and on 27-Apr-2022 who experienced the unexpected non serious AESI event of Covid-19 infection unknown days after receiving a dose of mRNA-1273 vaccine in the Covid-19 vaccination series. It was reported that the patient was treated with Paxlovid starting on 23-May to 28-May-2022 for Covid-19 treatment. Details of the onset date, lab results and symptoms of this initial Covid-19 infection and its outcome was not reported. Treatment for the event was not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.