Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04512A, 042L20A and 037K20A) for COVID-19 vaccination.     Patient was allergic to IVP dye.  Concurrent medical conditions included Blood pressure high and Gout. Concomitant products included ATENOLOL, LOSARTAN POTASSIUM (TEMISARTAN), HCTZ, ROSUVASTATIN CALCIUM (CRESTOR), AMLODIPINE, ALLOPURINOL, RABEPRAZOLE SODIUM (ACIPHEX), ASA and COENZYME Q10 [UBIDECARENONE] for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-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 experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient previously received a COVID-19 vaccine.   On an unknown date in 2022, patient tested positive for COVID-19, after receiving moderna vaccine.  Patient was taking other medications/products within two weeks of starting COVID-19 treatment.  On 28-May-2022 at 12:00, patient had rebound COVID symptoms (on day ten after taking medicines) and patient was tested positive.  Outcome for rebound COVID symptoms was reported as recovering.  Device date was reported as 04-Jun-2022.  Company comment: This spontaneous case concerns a 74-year-old male patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19. 10 days after taking the medicine patient experienced rebound COVID symptoms and tested positive for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old male patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19. 10 days after taking the medicine patient experienced rebound COVID symptoms and tested positive for COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.