Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 039K20A, 029L20A and 026C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Non-smoker. Concomitant products included LOSARTAN and BUPROPION for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency and REMDESIVIR from 09-Aug-2022 to 13-Aug-2022 for COVID-19 treatment, at an unspecified dose and frequency. In August 2022, COVID-19 (COVID infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 23-Aug-2022, SARS-CoV-2 test: (Negative) tested negative after 14 days of diagnosis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that, patient was not hospitalized not admitted to intense care unit for the event.  Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation.   Patient did not have any new or worsened symptoms/sign during COVID-19 illness experienced including multiorgan failure; respiratory failure, dyspnea, tachypnea, hypoxemia, COVID-pneumonia, respiratory failure, acute respiratory distress syndrome, cardiovascular, gastrointestinal/hepatic, vascular, renal, neurological, hematological, dermatological or multisystem inflammatory syndrome.  It was reported, patient did not require initiation of new medication or other treatment or procedure.  Patient was not treated with immunomodulating or immunocompromising medications or received any other vaccines around the time of COVID-19 vaccination.  Patient's no pre-exiting disease worsened during the SARS-CoV2 infection.  Company comment: This spontaneous case concerns a 67-year-old male patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred approximately 112 days after receiving the fourth dose of mRNA-1273 Vaccine in the COVID-19 vaccination series. Patient had received first two doses of the same vaccine at an interval of 30 days and third dose approximately 9 months later. It was reported that patient was given Remdesivir for 5 days and Paxlovid at an unspecified dose and frequency. Patient tested negative for SARS-CoV-2 test 14 days of after diagnosis of COVID-19. No further information on risk factors, clinical course, additional medical history, additional lab results and other treatment details were provided. The outcome of the event was recovered at the time of report. Ongoing COVID-19pandemic remains as a confounder for the event COVID-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 67-year-old male patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred approximately 112 days after receiving the fourth dose of mRNA-1273 Vaccine in the COVID-19 vaccination series. Patient had received first two doses of the same vaccine at an interval of 30 days and third dose approximately 9 months later. It was reported that patient was given Remdesivir for 5 days and Paxlovid at an unspecified dose and frequency. Patient tested negative for SARS-CoV-2 test 14 days of after diagnosis of COVID-19. No further information on risk factors, clinical course, additional medical history, additional lab results and other treatment details were provided. The outcome of the event was recovered at the time of report. Ongoing COVID-19pandemic remains as a confounder for the event COVID-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.