Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oedema peripheral, Peripheral swelling, Psoriatic arthropathy, Vaccination site pain
Clinical narrative: psoriatic arthritis flare up; puffy hands; Swelling of hands; Had pfizer vaccines and headaches; Had pfizer vaccines and sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4411554-00.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 04Aug2020 (ongoing) (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Had pfizer vaccines and headaches"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Had pfizer vaccines and sore arm"; PSORIATIC ARTHROPATHY (non-serious), outcome "not recovered", described as "psoriatic arthritis flare up"; OEDEMA PERIPHERAL (non-serious), outcome "not recovered", described as "puffy hands"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Swelling of hands". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare up", "puffy hands" and "swelling of hands" 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. The reporter considered "had pfizer vaccines and sore arm" and "had pfizer vaccines and headaches" related to BNT162b2.  Had Pfizer Vaccines and Headaches and Sore Arm, Psoriatic Arthritis Flare Up and Puffy Hands with Humira (Adalimumab). On unknown dates, the patient experienced Psoriatic Arthritis Flare Up and Puffy Hands. In 2021, the patient experienced Had Pfizer Vaccines and Headaches and Sore Arm. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Had Pfizer Vaccines And Headaches And Sore Arm onset in 2021 and Had Pfizer Vaccines And Headaches And Sore Arm onset in 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Psoriatic Arthritis Flare Up and Puffy Hands with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided,  the causal association between the events   psoriatic arthropathy, vaccination site pain, oedema peripheral, peripheral swelling,headache  and the suspect product  BNT162b2 cannot be excluded. The case will be reassessed once new information is available.