Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: COVID-19; Cold; Lack of efficacy; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), NASOPHARYNGITIS (Cold) and DRUG INEFFECTIVE (Lack of efficacy). The patient was hospitalized on sometime in August 2021 due to COVID-19. The patient was treated with REMDESIVIR (intravenous) at a dose of UNK UNK, qd; ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency; DEXAMETHASONE at a dose of 10 mg once a day and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), NASOPHARYNGITIS (Cold) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication included Insulin for diabetes.  It was reported that, patient had cold in August 2021 and then tested positive for COVID-19. He stated that he was hospitalized for 5 days in isolation unit. He was given Remdesivir intravenous (IV) daily, Albuterol, Dexamethasone 10 mg daily, Lovenox, and Insulin (due to being diabetic).  This is a case of Lack of Efficacy that concerns an 81-year-old male patient with relevant medical history of Diabetes, who experienced the unexpected serious adverse event of special interest COVID-19. The event, which caused hospitalization for the patient, occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The patient was hospitalized for 5 days and treatment was given, outcome of the events and the patient is unknown. The medical history of diabetes and advance age remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Lack of Efficacy that concerns an 81-year-old male patient with relevant medical history of Diabetes, who experienced the unexpected serious adverse event of special interest COVID-19. The event, which caused hospitalization for the patient, occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The patient was hospitalized for 5 days and treatment was given, outcome of the events and the patient is unknown. The medical history of diabetes and advance age remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.