Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Presented his first COVID symptoms and tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Presented his first COVID symptoms and tested positive) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 046A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Allergy, Asthma, Von Willebrand's disease (Type 2b) and Drug allergy. Concomitant products included PREDNISONE from 17-May-2022 to 29-May-2022, MOMETASONE, AZELASTINE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA), ROSUVASTATIN from an unknown date to 25-May-2022, SALBUTAMOL (ALBUTEROL HFA) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (Presented his first COVID symptoms and tested positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 31-May-2022 for COVID-19 prophylaxis, at an unspecified dose and frequency. At the time of the report, COVID-19 (Presented his first COVID symptoms and tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient had allergy to an unknown drug. It was reported that the patient presented first COVID symptoms and tested positive on May 25. The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. On June 1 and 2 (days7 and 8 of treatment), positive antigen test results became decreasingly pronounced until they were barely perceptible on June 2. On June 3 (day 11 of treatment), the antigen test results became more pronounced, and by end-of-day of June 5 symptoms which had diminished had fully returned (cough, congestion, runny nose, fatigue). Device Date was reported as 06-Jun-2022.  Company comment: This is a spontaneous case concerning a 48-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected event of COVID-19, which occurred about 6 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses with Moderna vaccine at an interval of 28 days, with the last dose given about 7 months prior to the 3 dose. Concurrent medical conditions included Diabetes and asthma. On 25-May-2022, the patient experienced his first COVID symptoms and tested positive. It was reported that the patient received Paxlovid for 6 days from 26 May to 31 May 2022, for covid 19. The event had not resolved. The ongoing Covid 19 pandemia is a confounder. It was reported that on 1 and 2 June 2022, (days 7 and 8), antigen test results were less pronounced until they were barely perceptible on June 2. Starting June 3 (day 11), the antigen test results became more pronounced, and by end-of-day June 5 , his symptoms, which had diminished fully, returned (cough, congestion, runny nose, fatigue). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This is a spontaneous case concerning a 48-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected event of COVID-19, which occurred about 6 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient received the 2 primary doses with Moderna vaccine at an interval of 28 days, with the last dose given about 7 months prior to the 3 dose. Concurrent medical conditions included Diabetes and asthma. On 25-May-2022, the patient experienced his first COVID symptoms and tested positive. It was reported that the patient received Paxlovid for 6 days from 26 May to 31 May 2022, for covid 19. The event had not resolved. The ongoing Covid 19 pandemia is a confounder. It was reported that on 1 and 2 June 2022, (days 7 and 8), antigen test results were less pronounced until they were barely perceptible on June 2. Starting June 3 (day 11), the antigen test results became more pronounced, and by end-of-day June 5 , his symptoms, which had diminished fully, returned (cough, congestion, runny nose, fatigue). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.