Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; Covid-19 (01-MAR-2021 Dose-1/ 28-MAR-2021 dose-2); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Covid-19 (01-MAR-2021 Dose-1/ 28-MAR-2021 dose-2)) 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]) injection for Plaque psoriasis.    Concurrent medical conditions included Psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 05-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Covid-19 (01-MAR-2021 Dose-1/ 28-MAR-2021 dose-2)). At the time of the report, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (Covid-19 (01-MAR-2021 Dose-1/ 28-MAR-2021 dose-2)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if patient was enrolled in a covid-19 vaccine trial. Patient was suppose to take Skyrizi  second dose on 29 Dec 2021 but not taken.  Patient was advised to hold Skyrizi therapy. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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 76-year-old, male patient with an underlying chronic plaque psoriasis treated with Risankizumab, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Vaccination failure was noted in this case. Doses 1 and 2 were given 27 days apart. A positive COVID-19 test confirmed the diagnosis approximately 8 months post vaccination with the 2nd dose. A 3rd dose of mRNA-1273 vaccine was given approximately 3 months after obtaining a positive COVID-19 test. Outcome of the event COVID-19 was reported as resolved. Patient's elderly age, underlying chronic plaque psoriasis, and treatment with Risankizumab may have predisposed the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received include : Lab test (COVID-19 virus test ) added, Suspect (Moderna) dosage details added, Current condition update.; Sender's Comments: This spontaneous case concerns a 76-year-old, male patient with an underlying chronic plaque psoriasis treated with Risankizumab, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Vaccination failure was noted in this case. Doses 1 and 2 were given 27 days apart. A positive COVID-19 test confirmed the diagnosis approximately 8 months post vaccination with the 2nd dose. A 3rd dose of mRNA-1273 vaccine was given approximately 3 months after obtaining a positive COVID-19 test. Outcome of the event COVID-19 was reported as resolved. Patient's elderly age, underlying chronic plaque psoriasis, and treatment with Risankizumab may have predisposed the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.