Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Intervertebral disc degeneration, Psoriasis, Psoriatic arthropathy, Rheumatoid arthritis
Clinical narrative: Psoriatic Arthritis; Psoriasis; Degenerative disc disease; Interchange of vaccine products; Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4190564.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1163328) at 40 mg (40 mg (40mg/0.4ml)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1 Single, Route of indication: Intramuscular), administration date: 18Dec2020, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose 2 Single, Route of indication: Intramuscular), administration date: 06Jan2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Apr2022, outcome "unknown"; RHEUMATOID ARTHRITIS (medically significant) with onset Apr2022, outcome "recovered" (2022), described as "Rheumatoid arthritis flare up"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic Arthritis"; PSORIASIS (non-serious), outcome "unknown"; INTERVERTEBRAL DISC DEGENERATION (non-serious), outcome "not recovered", described as "Degenerative disc disease". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "psoriatic arthritis", "psoriasis" and "degenerative disc disease" related to BNT162b2. The reporter's assessment of the causal relationship of "interchange of vaccine products" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causalities: The reporter's causality for the event(s) of Degenerative disc disease, Psoriasis, Psoriatic Arthritis and Rheumatoid arthritis flare up with Adalimumab Solution for Injection was Not Provided The reporter's causality for the event(s) of Degenerative disc disease, Psoriasis, Psoriatic Arthritis and Rheumatoid arthritis flare up with Moderna Covid-19 vaccine (Elasomeran) was Reasonable Possibility The reporter's causality for the event(s) of Degenerative disc disease, Psoriasis, Psoriatic Arthritis and Rheumatoid arthritis flare up with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was Reasonable Possibility  Company's opinion was that the causality for the event(s) of Degenerative disc disease, Psoriasis, Psoriatic Arthritis and Rheumatoid arthritis flare up with Adalimumab Solution for Injection was Not Provided Company's opinion was that the causality for the event(s) of Degenerative disc disease, Psoriasis, Psoriatic Arthritis and Rheumatoid arthritis flare up with Moderna COVID-19 vaccine (Elasomeran) was Not Provided Company's opinion was that the causality for the event(s) of Degenerative disc disease, Psoriasis, Psoriatic Arthritis and Rheumatoid arthritis flare up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.