Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, COVID-19 immunisation, Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; COVID-19; second dose administered after more than 35 days of primary dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered after more than 35 days of primary dose), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered after more than 35 days of primary dose). In July 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered after more than 35 days of primary dose), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            Concomitant medications details were not reported by the reporter.  In Jul 2022, the patient had COVID-19 and was unable to contact dermatologist. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of COVID-19 with SKYRIZI(RISANKIZUMAB) was no reasonable possibility and for PFIZER BIONTECH COVID-19 VACCINE it was reported as Possible.  Treatment details were not reported by the reporter.  Company comment: This spontaneous case concerns a 64-years-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 approximately 1 year 3 months after the second dose of mRNA-1273 vaccine. There was inappropriate schedule of product administration (second dose administered after more than 35 days of primary dose). It was also noted that patient received the third dose with TOZINAMERAN (PFIZER BIONTECH COVID-19) approximately 3 months after the second dose of mRNA-1273 vaccine (interchange of vaccine products). The Clinical course, and treatment details were not provided, and the event outcome was unknown.  Ongoing COVID-19 Pandemic and interchange of vaccine product remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 64-years-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 approximately 1 year 3 months after the second dose of mRNA-1273 vaccine. There was inappropriate schedule of product administration (second dose administered after more than 35 days of primary dose). It was also noted that patient received the third dose with TOZINAMERAN (PFIZER BIONTECH COVID-19) approximately 3 months after the second dose of mRNA-1273 vaccine (interchange of vaccine products). The Clinical course, and treatment details were not provided, and the event outcome was unknown.  Ongoing COVID-19 Pandemic and interchange of vaccine product remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.