Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic product effect decreased
Clinical narrative: ocular migraines; experienced Hormone replacement; ears were crusty; body was not well; hands/arms and joint pain became awful; hands/arms and joint pain became awful; Humira did not last longer; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4277236-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 1, single, intramuscular, administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 10Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2021 (Lot number: 1152635) to 29Oct2021 at citrate free for psoriatic arthropathy. Relevant medical history included: "Ocular Migraines" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX; NABUMETONE; PREMARIN, start date: 2017. The following information was reported: HORMONE REPLACEMENT THERAPY (medically significant), outcome "unknown", described as "experienced Hormone replacement"; EAR DISORDER (medically significant) with onset 2021, outcome "unknown", described as "ears were crusty"; OPHTHALMIC MIGRAINE (medically significant), outcome "recovering", described as "ocular migraines"; MALAISE (medically significant) with onset 2021, outcome "unknown", described as "body was not well"; ARTHRALGIA (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 2021, outcome "unknown" and all described as "hands/arms and joint pain became awful"; THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant) with onset 2021, outcome "unknown", described as "Humira did not last longer". The action taken for adalimumab was dosage permanently withdrawn on 29Oct2021.  Clinical Information: The patient reported that first two doses of Covid vaccine were started before Humira. On unknown dates, she experienced hormone replacement and ocular migraines. In 2021, she experienced ears were crusty, body was not well, hands, arms and joint pain became awful and Humira did not last longer. She experienced some ocular migraines before starting Humira and after but did not last more than 20 to 30 minutes and felt fine. She was on hormone replacement and Premarin was started in 2017. She was on Celebrex and Nabumetone. Her Humira was discontinued on 29Oct2021. Her Humira device was pain less.  Causality for Humira (ADALIMUMAB): The reporter's causality for the event(s) of hormone replacement, ocular migraines, ears were crusty, body was not well, hands/arms and joint pain became awful onset in 2021, hands/arms and joint pain became awful onset in 2021 and Humira did not last longer with Humira (ADALIMUMAB) was no reasonable possibility.  Causality for Humira (PFIZER BIONTECH COVID-19 VACCINE): The reporter's causality for the event(s) of hormone replacement, ocular migraines, ears were crusty, body was not well, hands/arms and joint pain became awful onset in 2021, hands/arms and joint pain became awful onset in 2021 and Humira did not last longer with PFIZER BIONTECH COVID-19 VACCINE was not reported.  opinion is that there is no reasonable possibility that the events of hormone replacement, ears were crusty, ocular migraines, hands/arms and joint pain became awful onset in 2021, hands/arms and joint pain became awful onset in 2021 and Humira did not last longer are related to Humira (ADALIMUMAB). opinion is that the event of body was not well is not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Hormone replacement therapy, Ear disorder, ophthalmic migraine, malaise, arthralgia, pain in extremity and therapeutic product effect decreased.  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.