Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 positive after Dose 2; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 positive after Dose 2) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     The patient's past medical history included Convalescent plasma transfusion on 22-Dec-2021. Concurrent medical conditions included Clot blood and Blood disorder.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced COVID-19 (COVID-19 positive after Dose 2). At the time of the report, COVID-19 (COVID-19 positive after Dose 2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) 3 month prior to booster.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have immediate allergic reaction to any vaccine, Injection or shot or to any component of C0VID-19 vaccine or a severe allergic reaction to anything. Patient did not had history of cancer, leukemia, HIV/AIDS or any other condition that weakens the immune system. In the last 10 days, patient did not have CO\/ID-19 test because of symptoms or isolated or quarantine at home due to COVID-19 infection or exposure. On 22-Dec-2021, patient was treated with antibody therapy or convalescent plasma for COVID-19 in the past 90 days. Patient was not taking any medications that affect immune system such as cortisone, prednisone or other steroids, anticancer drugs or had radiation treatments. Patient did not have history of myocarditis or pericarditis. Patient has not taken any other vaccines and did not develop thrombosis with thrombocytopenia syndrome. Patient was not feeling sick on the day of vaccination. Company comment-This Spontaneous case concerns a 66-year-old, male patient with no relevant medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), on unspecified day after second dose of mRNA-1273 Vaccine administration. Patient was diagnosed to have Covid -19 three months prior to booster dose which was given on 25th March 2022. No details of 1st and 2nd dose was provided hence Lack of Efficacy cannot be considered. No further details on clinical course, lab test results were reported. On 22nd December 2021 he was treated with antibody therapy or convalescent plasma for covid-19 for the past 90 days. At the time of the reporting, outcome of the event was not known. The current pandemic situation of COVID 19 may remain a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-531909 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 66-year-old, male patient with no relevant medical history reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), on unspecified day after second dose of mRNA-1273 Vaccine administration. Patient was diagnosed to have Covid -19 three months prior to booster dose which was given on 25th March 2022. No details of 1st and 2nd dose was provided hence Lack of Efficacy cannot be considered. No further details on clinical course, lab test results were reported. On 22nd December 2021 he was treated with antibody therapy or convalescent plasma for covid-19 for the past 90 days. At the time of the reporting, outcome of the event was not known. The current pandemic situation of COVID 19 may remain a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.