Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Hernia, International normalised ratio, Joint range of motion decreased
Clinical narrative: Rheumatoid arthritis flare up; Diabetes mellitus aggravated; Hernia; Back pain; knee osteoarthritis (bone to bone on right knee); Blood sugar abnormal; difficulty in walking (could not barely walk); Pain in hand; tiredness; joint range of motion decreased (could not open and close left hand); hand swelling (swelling of left hand); This is a Solicited report from a contactable consumer (patient) based on the information received by Pfizer (Mfr. Control No: 21K-163-3852687-00).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, tozinameran), intramuscular on 12Apr2021 at the age of 76-year-old (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ, 15 mg tablet) (Batch/Lot number was not reported), oral from Oct2020 to 08Feb2021, oral from 22Feb2021 to 06May2021, oral from 07May2021 and ongoing, all at 15 mg, 1x/day for moderate to severe rheumatoid arthritis. Medical history included internal Bleeding from Dec2018, small bowel resection from Dec2018, large mass in her small intestine from Dec2018 to, Diabetes from 1960, Rheumatoid Arthritis from 1987, On Pacemaker from 2012, Abdominal hernia from 2019 to 02Jun2021, No Tobacco User, Rheumatoid Arthritis Pain, Slow Heart Rate, Pain, Knee replacement on 15Feb2021, abstain from alcohol. No known allergies. The patient was hospitalized for ten days and was placed in the intensive care unit due to internal bleeding in Dec2018 and was scheduled for a small bowel resection procedure to remove the large mass in her small intestine then went to rehabilitation for two to three weeks before she was sent home. Concomitant medications included methotrexate, discontinued; paracetamol (TYLENOL) taken for rheumatoid arthritis pain; gabapentin (NEURONTIN) taken for pain; prednisone taken for rheumatoid arthritis; flecainide taken for slow heart rate; metoprolol taken for heart (as reported); warfarin sodium (JANTOVEN, Capsule) taken for blood thinner; venlafaxine (Capsule) taken for pain. The patient experienced rheumatoid arthritis flare up, diabetes mellitus aggravated, hernia, back pain, knee osteoarthritis (bone to bone on right knee), blood sugar abnormal, pain in hand, difficulty in walking (could not barely walk), tiredness, all on an unspecified date, joint range of motion decreased (could not open and close left hand) and hand swelling (swelling of left hand) on 13May2021.  Clinical course: Solicited report of a 76 year old female with events of knee surgery, hernia, pain in back, bone to bone on right knee and knee replacement and non-serious blood sugar levels unstable, could not open and close left hand, swelling of left hand, could not barely walk, pain in hands, diabetes flared up and rheumatoid arthritis flare up with rinvoq (upadacitinib).  Since 2012, the patient was also on pacemaker and her physician informed her that her pacemaker had only one year left and needs to be replaced but she decided to wait for a few months in order for her to recuperate first. She also wears a compression brace on her left hand to manage swelling. She shared that few months ago before she had her knee replacement procedure, she could not barely walk because of arthritis pain. She added that she was on knee brace when she decided to had the knee replacement procedure on 15Feb2021. She was admitted for six days after the knee replacement procedure and was given unrecalled pain relievers and antibiotics. It was unknown if she was enrolled in a covid-19 vaccine trial. In Apr2021, the patient experienced knee surgery. On 12Apr2021, she received first dose covid-19 vaccine manufactured by pfizer. Her first dose of covid-19 vaccine that was caused pain in her rheumatoid arthritis and diabetes flared up, and elevated blood sugar level with a result of over 400 milligrams per deciliter that was why she was advised by her physician not to take the second covid-19 vaccine dose. She noticed that after she took rinvoq again in May2021, her blood sugar went up. In May2021, she had five hernias and had surgery in stomach. On 13May2021, she had another procedure for her abdominal hernia. She mentioned that her hernia was located in five different places, there were two on her left lower abdominal area and three on the right lower area. She stayed in the hospital for six days until 20May2021 and was treated with unrecalled antibiotics and pain relievers. Her rinvoq was placed on hold one week prior and after those two procedures. Ablation in three nerves in back due to pain, experienced tiredness and pain in hands. Lowered prednisone dosing. The patient underwent lab tests and procedures which included Blood sugar level: 173 on 09Jun2021, elevated over 400 milligrams per deciliter in 2021, Went up in 2021; sugar: unstable sugar level; computed tomography scan: bone to bone on right knee; international normalized ratio test: 2.1 on 09Jun2021; X-ray: Bone to bone on right knee.  The action taken in response to the events for bnt162b2 was not applicable, for upadacitinib was dose not changed. The outcome of knee osteoarthritis, joint range of motion decreased, hand swelling was recovering, outcome of blood sugar abnormal was not recovered, outcome of other events was unknown.   Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of knee surgery, hernia, pain in back, knee replacement, could not barely walk, pain in hands, diabetes flared up and rheumatoid arthritis flare up was not provided. The reporter's causality for the event(s) of bone to bone on right knee, could not open and close left hand and swelling of left hand with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of blood sugar levels unstable with Rinvoq (Upadacitinib) was a reasonable possibility.   Company opinion is that there is no reasonable possibility that the events of knee surgery, hernia, pain in back, bone to bone on right knee, knee replacement, blood sugar levels unstable, could not open and close left hand, swelling of left hand, could not barely walk, pain in hands, diabetes flared up and rheumatoid arthritis flare up are related to Rinvoq (Upadacitinib).   Drug: Rinvoq (15 milligram, tablet) (Upadacitinib) Causality: Knee surgery, Hernia, Back pain: Action(s) taken with drug: Unknown, Causality as per reporter (drug/vaccine): Not reported, Causality as per mfr.(drug/vaccine): No reasonable possibility, Dechallenge: N/A; Knee osteoarthritis: Action(s) taken with drug: Drug discontinued, Outcome after reintro. of dose: Unknown, Causality as per reporter (drug/vaccine): Not related, Causality as per mfr.(drug/vaccine): No reasonable possibility, Dechallenge: Yes, Rechallenge: Yes rechall, unk recur; Knee replacement: Action(s) taken with drug: Drug discontinued, Causality as per reporter (drug/vaccine): Not reported, Causality as per mfr.(drug/vaccine): No reasonable possibility, Dechallenge: Unk; Blood sugar abnormal: Action(s) taken with drug: Unknown, Causality as per reporter (drug/vaccine): Possible, Causality as per mfr.(drug/vaccine): No reasonable possibility, Dechallenge: N/A;  Joint range of motion decreased: Action(s) taken with drug: Drug discontinued, Outcome after reintro. of dose: Unknown, Causality as per reporter (drug/vaccine): Not related, Causality as per mfr.(drug/vaccine): No reasonable possibility, Dechallenge: Yes, Rechallenge:  Yes rechall, unk recur; Hand swelling: Action(s) taken with drug: Drug discontinued, Outcome after reintro. of dose: Unknown, Causality as per reporter (drug/vaccine): Not related, Causality as per mfr.(drug/vaccine): No reasonable possibility, Dechallenge: Yes, Rechallenge: Yes rechall, unk recur; Difficulty in walking (gait disturbance): action(s) taken with drug: drug discontinued, causality as per reporter (drug/vaccine): not reported, causality as per mfr.(drug/vaccine): no reasonable possibility, dechallenge: unk; pain in hand: action(s) taken with drug: unknown, causality as per reporter (drug/vaccine): not reported, causality as per mfr.(drug/vaccine): no reasonable possibility, dechallenge: N/A; diabetes mellitus aggravated: action(s) taken with drug: unknown, causality as per reporter (drug/vaccine): not reported, causality as per mfr.(drug/vaccine): no reasonable possibility, dechallenge: N/A; rheumatoid arthritis flare up: action(s) taken with drug: unknown, causality as per reporter (drug/vaccine): not reported, causality as per mfr.(drug/vaccine): no reasonable possibility, dechallenge: N/A.   Pfizer BioNTech covid-19 vaccine(tozinameran) (injection)  causality: causality as per reporter (drug/vaccine): possible for events (knee surgery, hernia, back pain, pain in hand, diabetes mellitus aggravated, rheumatoid arthritis flare up), not reported for other events.   The reporter's assessment of the causal relationship of the events (knee osteoarthritis, Blood sugar abnormal, Joint range of motion decreased, Hand swelling, Difficulty in walking, Tiredness) with the suspect products 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.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the reported events and 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.