Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Onycholysis, Pain in extremity, Peripheral swelling, Rheumatoid arthritis, Skin fissures
Clinical narrative: low hemoglobin; heel pain; toe pain; big toenail detachment; menorrhagia/menstruating for 28 days; reaction to covid 19 vaccine; feet pain; generalized inflammation to the point skin stretched; generalized inflammation to the point skin stretched and cracked; generalized inflammation; rheumatoid arthritis decompensated; generalized joint pain; swollen feet; FACILITATED COLLECT  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): 21K-131-4142567-00 (RA).  An adult female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (40mg/0.4ml) and second regimen subcutaneous since 2021 (ongoing) (Batch/Lot number: unknown) at 40 mg (40mg/0.4ml, 1 in 2 week) for rheumatoid arthritis; adalimumab (HUMIRA), subcutaneous since 14Aug2014 (Batch/Lot number: unknown) at 40 mg (40mg/0.8ml) for rheumatoid arthritis. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Daily Dose: (1 in 1 Once), Route of Administration: Intramuscular), administration date: 26Mar2021, for Covid-19 immunization; Bnt162b2 (Dose 2, Daily Dose: (1 in 1 Once), Route of Administration: Intramuscular), administration date: Apr2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Aug2021, outcome "not recovered", described as "rheumatoid arthritis decompensated"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset Oct2021, outcome "not recovered", described as "menorrhagia/menstruating for 28 days"; SKIN STRIAE (non-serious) with onset Aug2021, outcome "not recovered", described as "generalized inflammation to the point skin stretched"; SKIN FISSURES (non-serious) with onset Aug2021, outcome "not recovered", described as "generalized inflammation to the point skin stretched and cracked"; INFLAMMATION (non-serious) with onset Aug2021, outcome "not recovered", described as "generalized inflammation"; ONYCHOLYSIS (non-serious) with onset 27Oct2021, outcome "not recovered", described as "big toenail detachment"; HAEMOGLOBIN DECREASED (non-serious), outcome "not recovered", described as "low hemoglobin"; ARTHRALGIA (non-serious) with onset Aug2021, outcome "not recovered", described as "generalized joint pain"; PERIPHERAL SWELLING (non-serious) with onset Aug2021, outcome "not recovered", described as "swollen feet"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "heel pain"; PAIN IN EXTREMITY (non-serious) with onset 27Oct2021, outcome "not recovered", described as "toe pain"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "not recovered", described as "feet pain"; VACCINATION COMPLICATION (non-serious) with onset 29Aug2021, outcome "not recovered", described as "reaction to covid 19 vaccine". The patient underwent the following laboratory tests and procedures: haemoglobin: (Oct2021) 8, notes: No unit; (Nov2021) 8, notes: No unit; (Dec2021) 8, notes: No unit. The action taken for adalimumab was dosage not changed. The action taken for adalimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of rheumatoid arthritis, heavy menstrual bleeding, skin striae, skin fissures, inflammation, onycholysis, haemoglobin decreased, arthralgia, peripheral swelling, pain in extremity, pain in extremity, pain in extremity, vaccination complication.  ?The reporter's assessment of the causal relationship of the events with the suspect product was provided at the time of this report. Since possible determination has been received, the case is managed based on 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: Based on known drug safety profile, there is reasonable possibility of causal association between the events 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.