Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Therapeutic product effect decreased
Clinical narrative: Loss of effectiveness with Humira (adalimumab); Primary series was Janssen and booster was Moderna; Primary series was Janssen and booster was Moderna; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Loss of effectiveness with Humira (adalimumab)), INTERCHANGE OF VACCINE PRODUCTS (Primary series was Janssen and booster was Moderna) and COVID-19 IMMUNISATION (Primary series was Janssen and booster was Moderna) 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 COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 05-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. In 2021, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 05-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Primary series was Janssen and booster was Moderna) and COVID-19 IMMUNISATION (Primary series was Janssen and booster was Moderna). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Loss of effectiveness with Humira (adalimumab)). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Loss of effectiveness with Humira (adalimumab)) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Primary series was Janssen and booster was Moderna) and COVID-19 IMMUNISATION (Primary series was Janssen and booster was Moderna) outcome was unknown.            No concomitant product was reported. No treatment information was reported. The reporter's causality for the event with Humira was reported as reasonable possibility. The reporter's causality for the event with Janssen COVID-19 vaccine was reported as possible. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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.  Company comment: This spontaneous case concerns a 64 year old male patient with concurrent condition of Plaque psoriasis and non serious event of Therapeutic product effect decreased (reported as Loss of effectiveness with Humira (adalimumab), unknown days after receiving the third dose with mRNA-1273 vaccine. The patient received the previous two doses with co suspect JANSSEN COVID-19 vaccine. Interchange of vaccine products and COVID-19 immunisation were noted. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64 year old male patient with concurrent condition of Plaque psoriasis and non serious event of Therapeutic product effect decreased (reported as Loss of effectiveness with Humira (adalimumab), unknown days after receiving the third dose with mRNA-1273 vaccine. The patient received the previous two doses with co suspect JANSSEN COVID-19 vaccine. Interchange of vaccine products and COVID-19 immunisation were noted. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.