Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Psoriasis, Therapeutic product effect incomplete
Clinical narrative: Results were not what it should be with humira; plaque psoriasis  flare/breaking out; First dose on 1-Mar-2021 and second dose on 1-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (plaque psoriasis  flare/breaking out), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Results were not what it should be with humira) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Mar-2021 and second dose on 1-May-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-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 received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Mar-2021 and second dose on 1-May-2021). In May 2022, the patient experienced PSORIASIS (plaque psoriasis  flare/breaking out). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Results were not what it should be with humira). At the time of the report, PSORIASIS (plaque psoriasis  flare/breaking out), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Results were not what it should be with humira) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-Mar-2021 and second dose on 1-May-2021) outcome was unknown.            No concomitant medication was provided. It was reported that the cosuspect drug adalimumab was discontinued. The reporter considered the causality between adalimumab and psoriasis flare-up as not related. The reporter considered the causality between tozinameran and psoriasis flare-up and drug effect incomplete as possible. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.  Company comment: This spontaneous case concerns a 57-year-old female patient with Concurrent medical conditions of Plaque psoriasis, who experienced unexpected non serious events of Psoriasis and Therapeutic product effect incomplete which occurred after unspecified day after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was reported as additional event. It was noted that patient received TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) as the third dose 6 months after the mRNA-1273 vaccine (interchange of vaccine product). Patient's Concurrent medical conditions of Plaque psoriasis and interchange of vaccine product remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up document received contains significant information: Therapy details of Moderna COVID-19 Vaccine added, event Inappropriate schedule of vaccine administered added. On 03-Jun-2022: Follow-up document received contains significant information: event psoriasis flare-up verbatim, outcome updated and onset date added.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with Concurrent medical conditions of Plaque psoriasis, who experienced unexpected non serious events of Psoriasis and Therapeutic product effect incomplete which occurred after unspecified day after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was reported as additional event. It was noted that patient received TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) as the third dose 6 months after the mRNA-1273 vaccine (interchange of vaccine product). Patient's Concurrent medical conditions of Plaque psoriasis and interchange of vaccine product remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.