Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Wheezing
Clinical narrative: EPV virus was reactivated; Chronic fatigue; Patient was infected with Covid-19 virus after the two doses of vaccine; COVID-19/Positive with Covid-19/confirmed to be infected with Covid-19 virus; Coughing; Wheezing; First dose received on 30-Dec-2021 and Second dose receievd on 04-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION REACTIVATION (EPV virus was reactivated) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L2DA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr virus infection (EPV virus was reactivated) and Chronic fatigue (Having chronic fatigue for a long time already).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 30-Dec-2021 and Second dose receievd on 04-Feb-2021). On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Coughing) and WHEEZING (Wheezing). On 13-Aug-2021, the patient experienced COVID-19 (COVID-19/Positive with Covid-19/confirmed to be infected with Covid-19 virus) and DRUG INEFFECTIVE (Patient was infected with Covid-19 virus after the two doses of vaccine). On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (EPV virus was reactivated) (seriousness criterion medically significant) and FATIGUE (Chronic fatigue). On 04-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 30-Dec-2021 and Second dose receievd on 04-Feb-2021) had resolved. At the time of the report, EPSTEIN-BARR VIRUS INFECTION REACTIVATION (EPV virus was reactivated), COVID-19 (COVID-19/Positive with Covid-19/confirmed to be infected with Covid-19 virus), COUGH (Coughing), WHEEZING (Wheezing) and DRUG INEFFECTIVE (Patient was infected with Covid-19 virus after the two doses of vaccine) outcome was unknown and FATIGUE (Chronic fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: inconclusive (Positive) Positive with Covid 19.         No Concomitant product use was reported.  No treatment information was provided.  It was reported that last 04-Aug-2021, patient went to a hospital and undergone esophageal dilation.   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: Additional information received on 23-Aug-2021 and included Patient gender was updated to male from previously reported Female.; Sender's Comments: This is a case of Drug ineffective and Inappropriate schedule of vaccine administered with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded.