Sex: M
Vaccine: COVID19, UNK
Symptoms: Accidental exposure to product, Fatigue, Pain in extremity, Psoriatic arthropathy
Clinical narrative: PSORIATIC ARTHRITIS FLARE; SORE ARM AND A LITTLE FATIGUE AFTER COVID VACCINE unknown onset; SORE ARM AND A LITTLE FATIGUE AFTER COVID VACCINE unknown onset; PEN LEAKED ONTO SKIN; This is a Solicited report based on the information received by Pfizer from AbbVie (Mfr. Control No. :21K-163-4064065-00). A contactable consumer (patient) reported A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular on an unspecified date (at unknown age) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date at Citrate free for Psoriatic arthritis. The patient medical history was not reported. Concomitant medication included methotrexate (MXTE). A 52-year-old male with events of non-serious sore arm and a little fatigue after covid vaccine, psoriatic arthritis flare and pen leaked onto skin with humira (adalimumab). In 2021, the patient experienced Sore arm and a little fatigue after covid vaccine and pen leaked onto skin. In 2021, the patient experienced psoriatic arthritis flare. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received 1st dose COVID-19 Vaccine manufactured by Pfizer Biontech. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of sore arm and a little fatigue after COVID VACCINE unknown onset, sore arm and a little fatigue after COVID VACCINE unknown onset, PSORIATIC ARTHRITIS FLARE AND PEN LEAKED ONTO SKIN was not provided. For HUMIRA (adalimumab) with Fatigue Causality as per reporter (Drug/Vaccine): Not Reported, sore arm Causality as per reporter (Drug/Vaccine): Not Reported, Psoriatic arthritis aggravated Causality as per reporter (Drug/Vaccine): Not Reported; pen leaked onto skin Causality as per reporter (Drug/Vaccine): Not Reported. For Pfizer Biontech Covid-19 Vaccine with Fatigue Causality as per reporter (Drug/Vaccine): Possible, sore arm Causality as per reporter (Drug/Vaccine): Possible, Psoriatic arthritis aggravated Causality as per reporter (Drug/Vaccine): Not Reported, as pen leaked onto skin Causality per reporter (Drug/Vaccine): Not Reported. The reporter's assessment of the causal relationship of the events (Psoriatic arthritis aggravated, pen leaked onto skin Causality) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  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, fatigue, pain in extremity and accidental exposure to product and the suspect drug BNT162B2 cannot be excluded. 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.