Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme abnormal, Illness, Oxygen saturation, Pyrexia, SARS-CoV-2 test
Clinical narrative: Bilateral covid pneumonia in his lungs; Ill; Can't keep fluids down; Drug ineffective; COVID-19; Little fever/fever started going up; coughing; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Bilateral covid pneumonia in his lungs) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 039K20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COUGH (coughing) and DIARRHOEA (diarrhea). On 16-Nov-2021, the patient experienced PYREXIA (Little fever/fever started going up). On 21-Nov-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COVID-19 PNEUMONIA (Bilateral covid pneumonia in his lungs) (seriousness criterion medically significant), ILLNESS (Ill), VOMITING (Can't keep fluids down) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 PNEUMONIA (Bilateral covid pneumonia in his lungs), COUGH (coughing), DIARRHOEA (diarrhea) and ILLNESS (Ill) had not resolved and COVID-19 (COVID-19), PYREXIA (Little fever/fever started going up), VOMITING (Can't keep fluids down) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Hepatic enzyme abnormal: abnormal (abnormal) liver enzymes are up. On an unknown date, Oxygen saturation: 84-94 (abnormal) 84-94%.         Concomitant medications were not reported. No treatment information was provided by the reporter Company Comment: This spontaneous case concerns a 75 year old male with no medical history reported , who experienced , serious ( Medically Significant ) , unexpected AESI  events of Covid 19 pneumonia  which occurred on an unkown date in Nov. 2021  after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . Also on an unknown date in Nov, 2021 , he experienced  Serious ( Medically Significant  ) , unexpected events of hepatic enzyme abnormality and vomiting after vaccination with the 3rd dose of mRNA-1273 vaccine . Additional event of Drug ineffective was also coded for this case . I it was noted that the patient patient  made ER visit and it was suspected that he might already been infected upon receving the 3rd dose of the vaccine.  The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The age of the patient can be considered as a confounder for this case ( elderly population are vulnerable to Covid 19 infeciotn and its complications due to their altered immune response) The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received - Reporter details added On 30-Nov-2021: Follow up received - No New information; Sender's Comments: This spontaneous case concerns a 75 year old male with no medical history reported , who experienced , serious ( Medically Significant ) , unexpected AESI  events of Covid 19 pneumonia  which occurred on an unkown date in Nov. 2021  after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . Also on an unknown date in Nov, 2021 , he experienced  Serious ( Medically Significant  ) , unexpected events of hepatic enzyme abnormality and vomiting after vaccination with the 3rd dose of mRNA-1273 vaccine . Additional event of Drug ineffective was also coded for this case . I it was noted that the patient patient  made ER visit and it was suspected that he might already been infected upon receving the 3rd dose of the vaccine.  The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The age of the patient can be considered as a confounder for this case ( elderly population are vulnerable to Covid 19 infeciotn and its complications due to their altered immune response) The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.