Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/COVID-19 rapid test positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19/COVID-19 rapid test positive) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis (Bilat bronchiectasis) and Drug allergy. Concomitant products included MEDROXYPROGESTERONE, ESTRADIOL, LEVALBUTEROL [LEVOSALBUTAMOL] and IPRATROPIUM for an unknown indication.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19/COVID-19 rapid test positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/COVID-19 rapid test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) positive COVID-19 test. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Covid-19 rapid test 19 May 2022 positive. On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive PCR test 22 May 2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient began Paxlovid 14 May 2022, 1 day after starting symptoms, day of positive COVID-19 test. All doses completed, no missed doses. Mild course of symptoms largely improved by end of course (19 May 2022). Covid-19 rapid test 19 May 2022 positive. New symptoms 21 May 2022 increased fatigue. Positive PCR test 22 May 2022. New sinus/respiratory congestion reported on 23 May 2022 was ongoing as on 25 May 2022.   Company comment: This is a spontaneous case reported by a nurse. A 65-year-old female patient, with no relevant medical history, experienced non serious event of COVID-19  approximately 5 months after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. The patient was treated with Paxlovid, symptoms largely improved. New symptoms of fatigue and sinus/respiratory congestion started after ending treatment; SARS-CoV-2 test remained positive after all doses completed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a nurse. A 65-year-old female patient, with no relevant medical history, experienced non serious event of COVID-19  approximately 5 months after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. The patient was treated with Paxlovid, symptoms largely improved. New symptoms of fatigue and sinus/respiratory congestion started after ending treatment; SARS-CoV-2 test remained positive after all doses completed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.