Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 39-year-old female 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.    There was no reported medical history.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third 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. In 2022, the patient experienced COVID-19 (Covid-19). In 2022, COVID-19 (Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Covid-19. Concomitant medications were not reported.  Patient had fever, lost sense of smell and taste but better now. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported. Company comment: This Spontaneous case reported by consumer concerns a 39 years old female patient, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient previously received the 2 primary doses with Moderna vaccines at an interval of about 1 month, with the last dose given about 8 months prior to the 3 dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose for plaque Psoriasis. In 2022, the patient experienced COVID-19 with a positive test. No other information regarding comorbidities, risk factors, symptoms, labs, diagnostic procedures, and treatment was available in the report. Ongoing Covid 19 pandemia and use of Risankizumab are confounders. The event had resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case reported by consumer concerns a 39 years old female patient, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient previously received the 2 primary doses with Moderna vaccines at an interval of about 1 month, with the last dose given about 8 months prior to the 3 dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose for plaque Psoriasis. In 2022, the patient experienced COVID-19 with a positive test. No other information regarding comorbidities, risk factors, symptoms, labs, diagnostic procedures, and treatment was available in the report. Ongoing Covid 19 pandemia and use of Risankizumab are confounders. The event had resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.