Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19; Lack of Efficacy; started feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), COVID-19 (tested positive for covid-19) and DRUG INEFFECTIVE (Lack of Efficacy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prolapsed mitral valve (Patient was reported to feel some of the flutters due to this condition.). Concomitant products included VITAMIN 15, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) and CENTRUM SILVER +50 for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (started feeling bad). On 16-Oct-2021, the patient experienced COVID-19 (tested positive for covid-19) and DRUG INEFFECTIVE (Lack of Efficacy). The patient was treated with MONOCLONAL ANTIBODY 17-1A on 19-Oct-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started feeling bad) and DRUG INEFFECTIVE (Lack of Efficacy) had resolved and COVID-19 (tested positive for covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2021, SARS-CoV-2 test: negative (Negative) Tested negative for COVID-19. On 19-Oct-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         Concomitant medications include something for eyes. for uveitis  This is a case of drug ineffective in this 70-year-old, female patient, with medical history of prolapsed mitral valve, who experienced the non-serious, unexpected events of Covid-19 (AESI) and feeling abnormal. The events occurred  5 months after second dose of Moderna vaccine. The rechallenge is not applicable as patient received treatment of monoclonal antibody. The patient's age and history of prolapsed mitral valve may have increased her risk of getting Covid-19 infection. The event Covid-19 remains as a confounder to the event feeling abnormal. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-366602 (Patient Link).; Sender's Comments: This is a case of drug ineffective in this 70-year-old, female patient, with medical history of prolapsed mitral valve, who experienced the non-serious, unexpected events of Covid-19 (AESI) and feeling abnormal. The events occurred  5 months after second dose of Moderna vaccine. The rechallenge is not applicable as patient received treatment of monoclonal antibody. The patient's age and history of prolapsed mitral valve may have increased her risk of getting Covid-19 infection. The event Covid-19 remains as a confounder to the event feeling abnormal. The benefit-risk relationship of Moderna vaccine is not affected by this report.