Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Therapeutic product effect decreased
Clinical narrative: Drug effect decreased; Inappropriate schedule of product administration; This spontaneous case was reported by a non-health professional and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) in an elderly male 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.    Previously administered products included for Pneumonia: Pneumonia on 01-Sep-2021; for Product used for unknown indication: Flu shot on 25-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot and Pneumonia. Concurrent medical conditions included Plaque psoriasis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-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]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) outcome was unknown.            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 concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient stated that after those three shots, SKYRIZI  did not work as well. No treatment medications were reported.  Company comment  This is a spontaneous case reported by a consumer, concerning an elderly male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious event of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) unknown days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The primary 2 doses of m RNA1273 vaccine was given at an interval of about 3 months and 10 days, with the 2 dose given about 5 months prior to the 3 dose. Inappropriate schedule of product administration was noted, . The patient received shots of Pneumococcal vaccine 2 months prior to and Influenza vaccine, about a month prior to the 3 dose, which along with the use of RISANKIZUMAB (SKYRIZI for Plaque psoriasis remain as confounders.  Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning an elderly male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious event of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) unknown days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The primary 2 doses of m RNA1273 vaccine was given at an interval of about 3 months and 10 days, with the 2 dose given about 5 months prior to the 3 dose. Inappropriate schedule of product administration was noted, . The patient received shots of Pneumococcal vaccine 2 months prior to and Influenza vaccine, about a month prior to the 3 dose, which along with the use of RISANKIZUMAB (SKYRIZI for Plaque psoriasis remain as confounders.  Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.