Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Respiratory distress
Clinical narrative: Respiratory distress; Coughing/Extensive coughing; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISTRESS (Respiratory distress) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 12-Dec-2019, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced COUGH (Coughing/Extensive coughing) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 30-Jun-2022, the patient experienced RESPIRATORY DISTRESS (Respiratory distress) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-Jun-2022 to 01-Jul-2022 due to RESPIRATORY DISTRESS. In 2022, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, RESPIRATORY DISTRESS (Respiratory distress) and COUGH (Coughing/Extensive coughing) outcome was unknown.            No concomitant medications were provided by the reporter. Primary reporter did not have the lot number information, because the packaging was discarded. The patient reported flu like symptoms after fourth Covid booster in 2022 lasted a few days then developed into respiratory issues with extensive coughing. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of respiratory distress, flu like symptoms and extensive coughing was not provided for Skyrizi (Risankizumab). No treatment information was provided by the reporter.  Company Comment:  This is a spontaneous case concerning  a  67-year-old, male patient with no reported medical history, who experienced the unexpected serious (Hospitalization and Medically Significant) event of Respiratory distress and unexpected non-serious events of cough and Influenza like Illness. The events Cough and Influenza like Illness occurrence date was not specified, hence latency could not be assessed. The event Respiratory Distress occurred approximately 9 days after the third dose of mRNA-1273 Vaccine. The patient reported flu like symptoms after fourth Covid booster in 2022 lasted a few days then developed into respiratory issues with extensive coughing. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Influenza like illness had resolved, while Respiratory Distress  and cough outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  67-year-old, male patient with no reported medical history, who experienced the unexpected serious (Hospitalization and Medically Significant) event of Respiratory distress and unexpected non-serious events of cough and Influenza like Illness. The events Cough and Influenza like Illness occurrence date was not specified, hence latency could not be assessed. The event Respiratory Distress occurred approximately 9 days after the third dose of mRNA-1273 Vaccine. The patient reported flu like symptoms after fourth Covid booster in 2022 lasted a few days then developed into respiratory issues with extensive coughing. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Influenza like illness had resolved, while Respiratory Distress  and cough outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.