Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Inflammation, Pain in extremity, Synovial cyst
Clinical narrative: Irregular heart beat; Ganglion cyst on right hand caused tendon to frayed; Arm tendon inflammed; Tendon to frayed; Pain on hands; Not flex up and down; Inflammation in thumb; 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): 22K-163-4238565-00 (AbbVie).  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 19Feb2017 (Lot number: 1137671) to 02Jan2022 at 80 mg (citrate free (80 mg,1 in 1 wk)), second regimen subcutaneous from 06Feb2017 (Lot number: 1137671) to 06Feb2017 at 80 mg (80 mg, citrate free loading dose (80 mg,2 in 1 once)), third regimen subcutaneous from 24Jan2017 (Lot number: 1137671) to 24Jan2017 at 160 mg 1x/day (160 mg, 1x/day, (citrate free loading dose)) and fourth regimen subcutaneous from Jan2016 (Lot number: 1154341) to May2016 at 40 mg (40 mg, (citrate free (40 mg,1 in 2 wk))) for hidradenitis, rheumatoid arthritis, colitis ulcerative. Relevant medical history included: "Alcohol: Mixed Drink", start date: 1990, stop date: 1993; "Irregular Heart Beat", start date: 2011 (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing); "Hidradenitis Suppurativa" (unspecified if ongoing); "Esophageal acid reflux" (unspecified if ongoing); "Thyroid problem" (unspecified if ongoing); "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Non Tobacco User" (unspecified if ongoing), notes: ~~~. Family history included: "Familial History Of Heart Attack On Both Sides" (unspecified if ongoing), notes: Familial History Of Heart Attack On Both Sides; "Familial History Of Colon Cancer" (unspecified if ongoing); "Familial History Of Hidradenitis On Mother Side" (unspecified if ongoing). Concomitant medication(s) included: IMURAN [AZATHIOPRINE SODIUM] taken for colitis ulcerative, hidradenitis; APRISO taken for colitis ulcerative; PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for gastrooesophageal reflux disease; LIOTHYRONINE taken for thyroid disorder; LEVOTHYROXINE taken for thyroid disorder; PROZAC taken for depression; VERAPAMIL taken for hypertension. Past drug history included: Levaquin, reaction(s): "Allergy Manifested By Intestinal Upset", notes: Levaquin, Amoxicillin, Cefdinir Allergy Manifested By Intestinal Upset; Amoxicillin, reaction(s): "Allergy Manifested By Intestinal Upset", notes: Levaquin, Amoxicillin, Cefdinir Allergy Manifested By Intestinal Upset; Cefdinir, reaction(s): "Allergy Manifested By Intestinal Upset", notes: Levaquin, Amoxicillin, Cefdinir Allergy Manifested By Intestinal Upset; Codein, reaction(s): "Codein Allergy Manifested By Vomiting", notes: Codein Allergy Manifested By Vomiting; Oxycodone, reaction(s): "Oxycodone Allergy", notes: Oxycodone Allergy. The following information was reported: SYNOVIAL CYST (medically significant) with onset Mar2021, outcome "not recovered", described as "Ganglion cyst on right hand caused tendon to frayed"; INFLAMMATION (medically significant) with onset 2021, outcome "recovered" (2021), described as "Inflammation in thumb"; TENDONITIS (medically significant) with onset Mar2021, outcome "not recovered", described as "Arm tendon inflammed"; TENDON DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "Tendon to frayed"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "Pain on hands"; UNEVALUABLE EVENT (non-serious) with onset Mar2021, outcome "not recovered", described as "Not flex up and down"; HEART RATE IRREGULAR (non-serious), outcome "not recovered", described as "Irregular heart beat". The patient underwent the following laboratory tests and procedures: heart rate: (2011) irregular; x-ray: (Mar2021) ganglion cyst; x-ray limb: (Jan2022) ganglion cyst grown significantly. The action taken for adalimumab was temporarily withdrawn on May2016. Therapeutic measures were taken as a result of synovial cyst, inflammation, tendonitis, tendon disorder, pain in extremity, unevaluable event, heart rate irregular with Lipitor and Cortisone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. .    Clinical course: On 28Apr2021, she received second dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech via intramuscular route. Causality for Humira 40MG/0.4ML(Adalimumab)  The reporter's causality for the event(s) of ganglion cyst on right hand caused tendon to frayed onset in Mar2021, serositis of appendix/chain of events to appendix, inflammation in thumb, pain on hands, ganglion cyst on right hand caused tendon to frayed onset in Mar2021, arm tendon inflammed, irregular heart beat and could not flex up and down with Humira 40MG/0.4ML(Adalimumab) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of ganglion cyst on right hand caused tendon to frayed onset in Mar2021, serositis of appen-dix/chain of events to appendix, inflammation in thumb, pain on hands, ganglion cyst on right hand caused tendon to frayed onset in Mar2021, arm tendon inflammed, irregular heart beat and could not flex up and down are related to Humira 40MG/0.4ML(Adalimumab).   Causality as per reporter (drug/vaccine) : Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information in the case provided, the causal association between the reported  event and the suspect drug 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.