Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Sepsis
Clinical narrative: Sepsis; Infection; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis) in a 72-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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) at an unspecified dose. On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion medically significant) and INFECTION (Infection). At the time of the report, SEPSIS (Sepsis) had resolved and INFECTION (Infection) outcome was unknown.            No concomitant medications were reported.  Patient was having lot of infection the last infection he had that just cleared up was Sepsis so he and his physician were pausing the Skyrizi therapy to see if skyrizi was compromising his immune system.  It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the event of Sepsis was assessed as Reasonable possibility for cosuspect SKYRIZI. The reporter causality for the event of infection was assessed as Not Reported for cosuspect SKYRIZI. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 72-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis, who experienced the unexpected, serious (medically significant) event of sepsis and the unexpected, non-serious event of infection. The events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Skyrizi and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient had been having a lot of infection. The last infection that had just resolved was Sepsis so he and his doctor paused the Skyrizi therapy to see if the medication was compromising his immune system. No further details were provided. The co-suspect administration of Skyrizi remains a confounder for both events. The patient's advanced age (high risk for infections) also remains a confounder for both events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 72-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis, who experienced the unexpected, serious (medically significant) event of sepsis and the unexpected, non-serious event of infection. The events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Skyrizi and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient had been having a lot of infection. The last infection that had just resolved was Sepsis so he and his doctor paused the Skyrizi therapy to see if the medication was compromising his immune system. No further details were provided. The co-suspect administration of Skyrizi remains a confounder for both events. The patient's advanced age (high risk for infections) also remains a confounder for both events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.