Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 57-year-old male 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 Psoriatic arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe) and Psoriatic arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. 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) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter.  Moderna Vaccine all doses were administered one in once.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that In 2022, the COVID resolved.  The reporters causality for the events of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Treatment details were not reported by the reporter.  Company comment:  This spontaneous case report concerns a 57-year-old male patient with medical history of Plaque psoriasis and Psoriatic arthritis with Adalimumab therapy, who experienced non-serious unexpected event of special interest - COVID-19. The event occurred after the patient had received the mRNA-1273 vaccine (as booster dose), however the temporal relationship between the event and vaccine administration cannot be determined since date of vaccination was not provided. At the time of this report, the event had resolved and no further details were available for medical assessment. Co-suspect medication adalimumab remains a confounder for the reported event since the medication increases the risk of infections. Having in mind that the patient received Tozinameran COVID-19 vaccine prior to vaccination with the mRNA-1273 vaccine, Interchange of vaccine products and COVID-19 immunisation (Revaccination with different COVID-19 vaccine) are also considered in this specific case report. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a 57-year-old male patient with medical history of Plaque psoriasis and Psoriatic arthritis with Adalimumab therapy, who experienced non-serious unexpected event of special interest - COVID-19. The event occurred after the patient had received the mRNA-1273 vaccine (as booster dose), however the temporal relationship between the event and vaccine administration cannot be determined since date of vaccination was not provided. At the time of this report, the event had resolved and no further details were available for medical assessment. Co-suspect medication adalimumab remains a confounder for the reported event since the medication increases the risk of infections. Having in mind that the patient received Tozinameran COVID-19 vaccine prior to vaccination with the mRNA-1273 vaccine, Interchange of vaccine products and COVID-19 immunisation (Revaccination with different COVID-19 vaccine) are also considered in this specific case report. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.