Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasal congestion, Nasopharyngitis
Clinical narrative: He tested positive for Covid-19; Drug ineffective; postnasal drip; general cold symptoms; congestion; cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (general cold symptoms), NASAL CONGESTION (congestion), COUGH (cough), COVID-19 (He tested positive for Covid-19) and UPPER-AIRWAY COUGH SYNDROME (postnasal drip) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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. On 13-Aug-2021, the patient experienced NASOPHARYNGITIS (general cold symptoms) (seriousness criterion medically significant), NASAL CONGESTION (congestion) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant) and UPPER-AIRWAY COUGH SYNDROME (postnasal drip) (seriousness criterion medically significant). On 15-Aug-2021, the patient experienced COVID-19 (He tested positive for Covid-19) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, NASOPHARYNGITIS (general cold symptoms), NASAL CONGESTION (congestion), COUGH (cough), COVID-19 (He tested positive for Covid-19) and UPPER-AIRWAY COUGH SYNDROME (postnasal drip) outcome was unknown and DRUG INEFFECTIVE (Drug ineffective) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.         Concomitant product use was not provided by the reporter. No treatment information was provided.  Company Comment: This report refers to a case of Drug ineffective for mRNA-1273, lot # 013M20A and # 012L20A. Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the reporter's statement of a breakthrough infection and the compatibility of the events NASOPHARYNGITIS (general cold symptoms), NASAL CONGESTION (congestion), COUGH (cough) and UPPER-AIRWAY COUGH SYNDROME (postnasal drip) with a Covid-19 infection, these events are assessed as unlikely related to mRNA-1273.; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, lot # 013M20A and # 012L20A. Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the reporter's statement of a breakthrough infection and the compatibility of the events NASOPHARYNGITIS (general cold symptoms), NASAL CONGESTION (congestion), COUGH (cough) and UPPER-AIRWAY COUGH SYNDROME (postnasal drip) with a Covid-19 infection, these events are assessed as unlikely related to mRNA-1273.