Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012M20A) for COVID-19 vaccination.     Patient did not had allergies to medications, food, and other products.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Autoimmune disorder (4 years ago. Condition was stable with no relapses in the last 4 years), Congestive heart failure (Condition was stable) and Prostate cancer. Concomitant products included FUROSEMIDE for Congestive heart failure, OMEPRAZOLE, TAMSULOSIN, CARVEDILOL, ATORVASTATIN, ENALAPRIL and SERTRALINE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive (late Nov to early Dec 2021).         Other concomitant medications included unspecified injections for prostate cancer.  Patient was diagnosed with COVID-19 in late Nov to early Dec 2021  Company Comment: This is a spontaneous, lack of efficacy case that concerns a 93-year-old male patient with medical history of Autoimmune Disease, Congestive Heart Failure, and Prostate Cancer, who experienced the unexpected non-serious events of Vaccination Failure, and adverse event of special interest, COVID-19. The events occurred approximately 8-9 months after receiving the second dose of mRNA-1273 Vaccine with an interval of 30 days from the 1st dose. SARS-CoV-2 test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Autoimmune Disease, Congestive Heart Failure, and Prostate Cancer, and advance age of the patient remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  Treatment medications were not provided.   This case was linked to MOD-2022-564249 (Patient Link).; Sender's Comments: This is a spontaneous, lack of efficacy case that concerns a 93-year-old male patient with medical history of Autoimmune Disease, Congestive Heart Failure, and Prostate Cancer, who experienced the unexpected non-serious events of Vaccination Failure, and adverse event of special interest, COVID-19. The events occurred approximately 8-9 months after receiving the second dose of mRNA-1273 Vaccine with an interval of 30 days from the 1st dose. SARS-CoV-2 test yielded positive results, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Autoimmune Disease, Congestive Heart Failure, and Prostate Cancer, and advance age of the patient remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.