Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; Tested positive for COVID-19 after 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (Tested positive for COVID-19 after 3 doses) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 043B21A and 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Arthritis and Diabetes. Concomitant products included INFLIXIMAB (REMICADE) for Arthritis.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). 09-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after 3 doses). In December 2021, COVID-19 (Tested positive for COVID-19 after 3 doses) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 via a nasal swap kit.         The patient reported that the line on the test was barely visible and the patient had no symptoms prior to getting the booster. The patient was not experiencing any side effect currently. REMICADE stop date is 8-NOV  The patient was concerned because the patient read on that morning that some medications could affect the vaccine's ability to work, and indicated that the patient was taking Remicade. The patient was getting something different now for arthritis.  Company comment:  This case concerns a 66-years-old female patient, with reported medical history of Chronic obstructive pulmonary disease and Diabetes, who experienced the non-serious  of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 1 day after the administration of the third dose of a proper schedule of vaccination with the mRNA-1273 vaccine (31 days between doses) and, at the time of the report, the outcome was reported as Recovered/Resolved.  The causality is not applicable as per the nature of the event.  Further information received states that the patient was asymptomatic at the time of the report.  The rechallenge is not applicable as the events occurred after the administration of the third dose of the mRNA-1273 vaccine. Reported medical history of Chronic obstructive pulmonary disease and Diabetes remains as contributing factors to the event COVID-19.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Additional information includes Product PCID number added in product tab.; Sender's Comments: This case concerns a 66-years-old female patient, with reported medical history of Chronic obstructive pulmonary disease and Diabetes, who experienced the non-serious  of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 1 day after the administration of the third dose of a proper schedule of vaccination with the mRNA-1273 vaccine (31 days between doses) and, at the time of the report, the outcome was reported as Recovered/Resolved.  The causality is not applicable as per the nature of the event.  Further information received states that the patient was asymptomatic at the time of the report.  The rechallenge is not applicable as the events occurred after the administration of the third dose of the mRNA-1273 vaccine. Reported medical history of Chronic obstructive pulmonary disease and Diabetes remains as contributing factors to the event COVID-19.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.