Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Blood cholesterol increased, Gait inability, Limb discomfort, Magnetic resonance imaging
Clinical narrative: Sciatic Nerve Was Pinched Off; Rheumatoid arthritis flare up; Pain/Discomfort On Right Leg; Cholesterol Level Of 291 Milligrams Per Deciliter; Unrelaxed Nerve/Recurrent Unrelaxed Nerve; Pain; No Energy; Not Able To Hardly Walk; Pain Down To Left Leg/Pain/Discomfort On Right Leg; Not Able To Sit Down/Get Up; This is a solicited report from the marketing program received from a non-contactable consumer (patient) based on information received by Pfizer from via (manufacturer control number:21K-163-3922125-00) that:  Solicited report from a consumer of a 73 year old female with events of Laminectomy, Sciatic Nerve Was Pinched Off, Four Inch Incision At Back, Not Able To Hardly Walk, Pain Down To Left Leg And Unrelaxed Nerve and non-serious Pain, Not Able To Sit Down/Get Up, No Energy, Pain/Discomfort On Right Leg, Recurrent Unrelaxed Nerve, Cholesterol Level Of 291 Milligrams Per Deciliter And Rheumatoid Arthritis Flare Up With Rinvoq (Upadacitinib). The patient had a relevant medical history of Fatigue, No Tobacco Use, Abstain From Alcohol, Codeine Allergy Manifested By Vomit A Lot. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS FLARE UP. In Sept2019, the patient experienced Not Able To Sit Down/Get Up, Not Able To Hardly Walk And Pain Down To Left Leg. In 2020, the patient experienced No Energy. In 2021, the patient experienced Laminectomy and pain. In Mar2021, the patient experienced Sciatic Nerve Was Pinched Off And Unrelaxed Nerve. In Apr2021, the patient experienced Cholesterol Level Of 291 Milligrams Per Deciliter. On 06May2021, the patient experienced FOUR INCH INCISION AT BACK. On 06May2021, the Sciatic Nerve Was Pinched Off, Not Able To Sit Down/Get Up, Four Inch Incision At Back, Not Able To Hardly Walk, Pain Down To Left Leg And Unrelaxed Nerve resolved. On 09May2021, the patient experienced Pain/Discomfort On Right Leg And Recurrent Unrelaxed Nerve. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. On 06May2021 she had a laminectomy due to her sciatic nerve was pinched off on both sides of the body and was hospitalized for three days due to the procedure. That procedure had resulted have four inch incision at her back. In May 2021 had back surgery. She was not able to hardly walk and had excruciating pain at all times down to her left leg. There was no pain on her right leg before the laminectomy. Pain on her left leg was gone after the laminectomy. By the time she got home she realized that there was discomfort or pain going down to the right leg so she went back to physician office. She mentioned could also possibly be a worsened arthritis pain on right leg started going to her hip, thigh, calf and foot. She had unspecified vitamins as part of her concomitant medications. She experienced fatigue and pain while taking a break from the RINVOQ due to surgery. She did not have the expiration date of Covid19 vaccination because it was not on the vaccination card. She had a shot of Covid 19 vaccine before at least one symptom happened therefore Covid 19 vaccine was considered as cosuspect product. She did have a flare up with her joints and was experiencing a tremendous amount of fatigue lately in 2021.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 24Mar2021 patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number EP7534. On 14Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number EP7533. The patient was treated with PREDNISONE and KENALOG.  Causality for RINVOQ(UPADACITINIB) The reporters causality for the event(s) of Laminectomy, Pain, Four Inch Incision At Back, Cholesterol Level OF 291 Milligrams Per Deciliter And Rheumatoid Arthritis Flare Up was not provided. The reporters causality for the event(s) of Sciatic Nerve Was Pinched Off, Not Able To Sit Down/Get Up, No Energy, Not Able To Hardly Walk, Pain Down To Left Leg, Pain/Discomfort On Right Leg onset 09May2021, Pain/Discomfort On Right Leg onset 09May2021, Unrelaxed Nerve And Recurrent Unrelaxed Nerve With Rinvoq(Upadacitinib) was no reasonable possibility. Manufacturer opinion is that there is no reasonable possibility that the events of Laminectomy, Pain, Sciatic Nerve Was Pinched Off, Not Able To Sit Down/Get Up, No Energy, Four Inch Incision At Back, Not Able To Hardly Walk,Pain Down To Left Leg, Pain/Discomfort On Right Leg onset 09May2021, Pain/Discomfort On Right Leg onset 09May2021, Unrelaxed Nerve, Recurrent Unrelaxed Nerve And Rheumatoid Arthritis Flare Up are related to Rinvoq(Upadacitinib). Manufacturer opinion is that there is a reasonable possibility that the event of Cholesterol Level Of 291 Milligrams Per DECILITER is related to Rinvoq(Upadacitinib).   Relevant Laboratory & Other Diagnostic Tests Nov2020 Comprehesive Metabolic Panel: Cholesterol level of 190 milligrams per deciliter Normal 125 to 200 milligrams per deciliter Apr2021 COMPREHESIVE METABOLIC PANEL: Cholesterol level of 291 milligrams per deciliter Normal 125 to 200 milligrams per deciliter Mar2021 Magnetic Resonance Imaging: Confirmed sciatic nerve was pinched off   Change History On 27May2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The events of "Sciatic Nerve Was Pinched Off", "Not Able To Sit Down/Get Up", "Worsened Fatigue", "No Energy", "Four Inch Incision At Back", "Not Able To Hardly Walk", "Pain Down To Left Leg", "Pain/Discomfort On Right Leg", "Unrelaxed Nerve", "Recurrent Unrelaxed Nerve", "Possible Worsened Arthritis Pain" And "Cholesterol Level Of 291 Milligrams Per Deciliter" were added. The event of "Fatigue" was removed.  On 27Jul2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology and narrative description. The event of "Rheumatoid Arthritis Flare Up" was added. The events of "Possible Worsened Arthritis Pain" and "Worsened Fatigue" were removed.  The reporter assessed the events Pain Down To Left Leg/Pain/Discomfort On Right Leg, Discomfort On Right Leg, Unrelaxed Nerve/Recurrent Unrelaxed Nerve, Cholesterol Level Of 291 Milligrams Per Deciliter as unrelated to bnt162b2.   The reporter's assessment of the causal relationship of the events, except Pain Down To Left Leg/Pain/Discomfort On Right Leg,  Discomfort On Right Leg, Unrelaxed Nerve/Recurrent Unrelaxed Nerve, Cholesterol Level Of 291 Milligrams Per Deciliter, with the suspect product bnt162b2 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 needed. No further information is expected; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Rheumatoid arthritis, Nerve compression, Pain, Mobility Decreased,  Asthenia, Gait inability, Pain in extremity, Limb discomfort, Nervous system disorder, Blood cholesterol increased and the suspect drug Pfizer Biontech Covid-19 Vaccine (Tozinameran). The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.