Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, SARS-CoV-2 test, Vaccination complication
Clinical narrative: Breathing symptoms linger; Tested positive for covid.19; Terrible symptoms; Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing symptoms linger), COVID-19 (Tested positive for covid.19), VACCINATION COMPLICATION (Terrible symptoms) and DRUG INEFFECTIVE (Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DRUG INEFFECTIVE (Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021). On an unknown date, the patient experienced DYSPNOEA (Breathing symptoms linger), COVID-19 (Tested positive for covid.19) and VACCINATION COMPLICATION (Terrible symptoms). At the time of the report, DYSPNOEA (Breathing symptoms linger) had not resolved, COVID-19 (Tested positive for covid.19) and DRUG INEFFECTIVE (Got covid-19 month after getting both doses of the vaccine back in Feb2021 and Mar2021) outcome was unknown and VACCINATION COMPLICATION (Terrible symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Relevant concomitant medications were not provided.  Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  Company Comment: Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273.  This is also a case of Drug ineffective (Lack of drug effect) assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). Based on the current available information and temporal association between the use of the product and the tentative start date of the occurrence of the events, Dyspnoea (Breathing symptoms linger), Vaccination complication (Terrible symptoms), a causal relationship cannot be excluded.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273.  This is also a case of Drug ineffective (Lack of drug effect) assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). Based on the current available information and temporal association between the use of the product and the tentative start date of the occurrence of the events, Dyspnoea (Breathing symptoms linger), Vaccination complication (Terrible symptoms), a causal relationship cannot be excluded.