Age: 83.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Date of positive COVID-19 test: 01Aug2021; Vaccination failure; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Date of positive COVID-19 test: 01Aug2021) and VACCINATION FAILURE (Vaccination failure) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 062G20A) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (has 3 stints). Concurrent medical conditions included Diabetes, Sleep apnea, Hypertension, Leukemia, Immunocompromised, Dust allergy (Dust mite (postnasal drip)) and Mite allergy. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN ASPART (NOVOLOG), EMPAGLIFLOZIN (JARDIANCE), PANTOPRAZOLE, MONTELUKAST, SITAGLIPTIN PHOSPHATE (JANUVIA), AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), EZETIMIBE, FENOFIBRATE and POTASSIUM for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Aug-2021, the patient experienced COVID-19 (Date of positive COVID-19 test: 01Aug2021) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (Date of positive COVID-19 test: 01Aug2021) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: (Positive) Positive.         Treatment details was not reported by the reporter.  Company comment: This spontaneous case concerns a 83-year-old male patient, with no relevant medical history reported, who experienced the unexpected nonserious AESI of COVID-19, which occurred approximately 5 months after the second dose of mRNA-1273 vaccine. Vaccination failure was reported as an additional event. SARS-CoV-2 test was positive approximately 5 months after the second dose. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the events was reported as unknown. Ongoing pandemic of Covid-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The events were assessed as serious as per Regulatory Authority´s report.   This case was linked to MOD-2022-645250 (Patient Link).; Sender's Comments: This spontaneous case concerns a 83-year-old male patient, with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19, which occurred approximately 5 months after the second dose of mRNA-1273 vaccine. Vaccination failure was reported as an additional event. SARS-CoV-2 test was positive approximately 5 months after the second dose. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the events was reported as unknown. Ongoing pandemic of Covid-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The events were assessed as serious as per Regulatory Authority´s report.