Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 032L20A and 026L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma (Patient was taking singulair throughout pandemic for occasional asthma). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for Corona virus infection, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2022, SARS-CoV-2 test: positive (Positive) POSITIVE.         The patieny was taking singulair throughout pandemic for occasional asthma. The patient received first booster as a full dose. The patient received second booster on 28-MAR-2022. Reporter mentioned that two of them had breakthrough infections with the Moderna vaccine after all of their doses. They had 4 doses of Moderna each and were at a super spreader event. Tested positive for COVID on 04May2022 and was barely sick, one day felt kind of crappy. The patient stated that they had rebound (where the disease come back, not re-infected that was the same infection but that went away for a week and come back). Patient had to isolate.  Company Comment: This spontaneous case concerns a 70-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 38 days after the fourth of mRNA-1273 vaccine in covid-19 vaccination series. SARS-CoV-2 test was reported positive as on 04-May-2022. Patient was treated with Paxlovid (pfizer antiviral for COVID). Current ongoing pandemic of COVID-19 remains as a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-593865 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 38 days after the fourth of mRNA-1273 vaccine in COVID-19 vaccination series. SARS-CoV-2 test was reported positive as on 04-May-2022. Patient was treated with Paxlovid (pfizer antiviral for COVID). Current ongoing pandemic of COVID-19 remains as a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.