Age: 40.0
Sex: F
Vaccine: COVID19
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 40-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.    The patient's past medical history included Alcohol use in 2002 and Non-tobacco user. Concurrent medical conditions included Psoriasis and Psoriatic arthritis. Concomitant products included FOLIC ACID for Folic acid supplementation, HALOBETASOL, CALCIPOTRIENE and FLUOCINONIDE for Psoriasis, METHOTREXATE for Psoriatic arthritis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 in 12 wk. On 29-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Dec-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         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. No treatment information was reported.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 40-year-old female patient with concomitant medication of Risankizumab (Skyrizi) and Methotrexate, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 rapid antigen test, which occurred approximately 11 months after receiving the first dose of mRNA-1273 vaccine and 3 days after receiving the booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 33 days which falls within the recommended vaccine dosing schedule, approximately 9 months and 3 weeks prior to booster dose of mRNA-1273 vaccine. It was reported that the patient had associated cough, colds, congestion, headache and change of taste. Patient took allergy medication and consulted her doctor and was advised to undergo COVID-19 test. No further details about the treatments were provided. It was reported that the event COVID-19 was resolving. The co-suspect drug Risankizumab and concomitant medication Methotrexate, which are immunosuppressant, could increased the patient's susceptibility to have COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 40-year-old female patient with concomitant medication of Risankizumab (Skyrizi) and Methotrexate, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 rapid antigen test, which occurred approximately 11 months after receiving the first dose of mRNA-1273 vaccine and 3 days after receiving the booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 33 days which falls within the recommended vaccine dosing schedule, approximately 9 months and 3 weeks prior to booster dose of mRNA-1273 vaccine. It was reported that the patient had associated cough, colds, congestion, headache and change of taste. Patient took allergy medication and consulted her doctor and was advised to undergo COVID-19 test. No further details about the treatments were provided. It was reported that the event COVID-19 was resolving. The co-suspect drug Risankizumab and concomitant medication Methotrexate, which are immunosuppressant, could increased the patient's susceptibility to have COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.