Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Upper respiratory tract infection, Vaccination failure
Clinical narrative: COVID-19; Vaccination failure; Upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and VACCINATION FAILURE (Vaccination failure) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2022, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection). On 07-Jul-2022, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID-19) had not resolved, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) was resolving and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  The reporter causality with Skyrizi for COVID-19 and upper respiratory infection was no reasonable possibility and not provided respectively. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  Patient had cough that started several days ago as of July-2022. PCP diagnosed him with upper respiratory infection and prescribed antibiotic. Patient experienced COVID-19 infection on 9-Jul-2022. Patient denied other symptoms such as shortness of breath, fever. On an unknown date in 2022, patient attended church event and many people ended up testing positive for COVID-19 after the event.  Company comment-This spontaneous case concerns a male patient aged 76 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19  that occurred approximately 9 months 20 days after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 28 days. Patient had cough several days ago in July 2022, diagnosed as upper respiratory infection and treated with antibiotics by a physician. Later patient took home covid test which was positive. He had Covid on 7th July 2022. No further details available. Outcome of the event was not resolved at the time of report. Patient had attended a church event where many were tested positive for covid after the event. History of attending a public gathering and current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 76 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19  that occurred approximately 9 months 20 days after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 28 days. Patient had cough several days ago in July 2022, diagnosed as upper respiratory infection and treated with antibiotics by a physician. Later patient took home covid test which was positive. He had Covid on 7th July 2022. No further details available. Outcome of the event was not resolved at the time of report. Patient had attended a church event where many were tested positive for covid after the event. History of attending a public gathering and current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.