Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: The patient had tested positive for COVID-19 after second Moderna COVID-19 vaccine; Tested positive (PCR) for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION FAILURE (The patient had tested positive for COVID-19 after second Moderna COVID-19 vaccine) and COVID-19 (Tested positive (PCR) for COVID-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001B21A) for COVID-19 prophylaxis.     Allergies to medications, food and other products were none.  Concurrent medical conditions included Blood pressure high, Gout, Hypercholesterolemia and Obesity (Body mass index more than or equal to 30). Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, ALLOPURINOL for Gout, CHOLESTYRAMINE for Hypercholesterolemia.   On 17-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced VACCINATION FAILURE (The patient had tested positive for COVID-19 after second Moderna COVID-19 vaccine) and COVID-19 (Tested positive (PCR) for COVID-19). At the time of the report, VACCINATION FAILURE (The patient had tested positive for COVID-19 after second Moderna COVID-19 vaccine) and COVID-19 (Tested positive (PCR) for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Body temperature: 107 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient race was provided as black. It was reported that the patient did not have an acute illness at the time of vaccination and up to one month before.  The patient had COVID-19 symptoms as fever, chills, cough, muscle aches, headache with a duration of 3 days and diarrhea with nasal congestion/runny nose with a duration of 2 days. The patient did not have a clinical and radiographical evidence of pneumonia. The patient had not required a non-invasive supplemental oxygen, not admitted to intensive care unit, not required respiratory ventilator support or ECMO. Treatment information was provided as none. Company Comment:    This is an spontaneous case concerning a 39 year-old male patient with no medical history related who experienced the unexpected AESI of COVID-19, approximately 3 months after the 2nd. dose of mRNA-1273 vaccine.  Also, vaccination failure event was noted in this case. On 18-Jul-2021, SARS-CoV-2 test was Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reported.   This case was linked to MOD-2022-610667 (Patient Link).; Sender's Comments: Company Comment:    This is an spontaneous case concerning a 39 year-old male patient with no medical history related who experienced the unexpected AESI of COVID-19, approximately 3 months after the 2nd. dose of mRNA-1273 vaccine.  Also, vaccination failure event was noted in this case. On 18-Jul-2021, SARS-CoV-2 test was Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reported.