Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Felt like chest is heavy; COVID-19 infection; Vaccination failure; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Felt like chest is heavy), COVID-19 (COVID-19 infection) and VACCINATION FAILURE (Vaccination failure) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced CHEST DISCOMFORT (Felt like chest is heavy) (seriousness criterion medically significant), COVID-19 (COVID-19 infection) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, CHEST DISCOMFORT (Felt like chest is heavy) and COVID-19 (COVID-19 infection) was resolving and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) positive (Result received on 29-Dec-2021).         Concomitant medication was not reported. No treatment information was provided by the reporter. On 26-Dec-2021, Patient experienced itchy throat, shortness of breath (Subsumed under COVID-19 infection). This report was associated with product quality complaint : 90000210194  Company Comment: This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically Significant), AESI event of COVID-19 and the unexpected, serious (Medically Significant) events of Chest discomfort and Vaccination failure. The events occurred on 26-Dec-21, an unknown duration after the second dose of mRNA-1273 vaccine administered on an unknown date for the indication of Prophylactic Vaccination. At the time of report the outcome of the events of COVID-19 and Chest discomfort was Resolving. Further details about the events are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter's Comments: This event is considered not related. The event  has compatible/suggestive temporal relationship , is unlabeled and has unknown scientific plausibility. There are other factor more likely to be associated with event than the drug . Specifically : Special situation; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically Significant), AESI event of COVID-19 and the unexpected, serious (Medically Significant) events of Chest discomfort and Vaccination failure. The events occurred on 26-Dec-21, an unknown duration after the second dose of mRNA-1273 vaccine administered on an unknown date for the indication of Prophylactic Vaccination. At the time of report the outcome of the events of COVID-19 and Chest discomfort was Resolving. Further details about the events are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.