Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood cholesterol, Blood cholesterol abnormal, Blood test, Condition aggravated
Clinical narrative: Spinal laminectomy; recurrent unrelaxed nerve; possible worsened arthritis pain; Leg discomfort; leg pain; Nervous system disorder; Unable to walk; Blood cholesterol abnormal; Nerve root compression; Pain; Fatigue aggravated; Loss of energy; Mobility decreased; FACILITATED COLLECT  This is a solicited received by Pfizer(MFR Control No. # 21K-163- 3922125-00). A contactable consumer (patient) reported for herself that a 73-year-old female patient received bnt162b2, first dose intramuscular on 24Mar2021 (Batch/Lot Number: EP7534) as 1st dose, single dose, second dose via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: EP7533) as 2nd dose, single dose for covid-19 immunization; upadacitinib (RINVOQ, 15 Milligram, Tablet), orally from Sep2019 (Batch/Lot number was not reported) to 28Apr2021, at 15 mg, 1x/day, via an unspecified route of administration from 19May2021 (Batch/Lot number was not reported) and ongoing, at 15 mg, 1x/day for rheumatoid arthritis. Medical history included fatigue, non-tobacco user, abstain from alcohol; Codeine allergy manifested by vomit a lot, rheumatoid arthritis all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for thyroid; trazodone taken for Manage Sleep; tramadol taken for pain; sumatriptan taken for migraine; oxybutynin taken for bladder Control; fish oil taken for supplementation therapy; biotin taken for supplementation therapy, start and stop date were not reported for all drug. The patient experienced spinal laminectomy (hospitalization) in 2021 with outcome of not recovered, pain in 2021 with outcome of recovering, nerve root compression in Mar2021 with outcome of recovered on 06May2021, mobility decreased in Sep2019 with outcome of recovered on 06May2021, fatigue aggravated in 2020 with outcome of recovering, loss of energy in 2020 with outcome of not recovered, unable to walk(Gait inability) in Sep2019 with outcome of recovered on 06May2021, recurrent unrelaxed nerve on an unspecified date with outcome of unknown, possible worsened arthritis pain on an unspecified date with outcome of not recovered, leg discomfort on 09May2021 with outcome of not recovered, leg pain on 09May2021 with outcome of not recovered, nervous system disorder on 09May2021 with outcome of not recovered, blood cholesterol abnormal on Apr2021 with outcome of not recovered. The patient was hospitalized for spinal laminectomy for 3 days. Solicited report from the (address) by 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, worsened fatigue, no energy, pain/discomfort on right leg, recurrent unrelaxed nerve, possible worsened arthritis pain and cholesterol level of 291 milligrams per deciliter with rinvoq (upadacitinib). In Sep2019, 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 worsened fatigue and 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, recurrent unrelaxed nerve and possible worsened arthritis pain. 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. 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 co suspect product. 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. Relevant Laboratory & Other Diagnostic Tests included: In Nov2020 comprehesive metabolic panel: cholesterol level of 190 milligrams per deciliter normal 125 to 200 milligrams per deciliter; In Apr2021 comprehesive metabolic panel: cholesterol level of 291 milligrams per deciliter normal 125 to 200 milligrams per deciliter; In Mar2021 magnetic resonance imaging: confirmed sciatic nerve was pinched off.  Causality for RINVOQ (Upadacitinib): The reporter's causality for the event(s) of laminectomy, pain, four inch incision at back and cholesterol level of 291 milligrams per deciliter was not provided. the reporter's causality for the event(s) of sciatic nerve was pinched off, not able to sit down/get up, worsened fatigue, 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, recurrent unrelaxed nerve and possible worsened arthritis pain with rinvoq (upadacitinib) was no reasonable possibility. 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, worsened fatigue, 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 possible worsened arthritis pain are related to Rinvoq (opinion is that there is a reasonable possibility that the event of cholesterol level of 291 milligrams per deciliter is related to Rinvoq (upadacitinib). Causality of upadacitinib (RINVOQ) for Spinal laminectomy, Pain per reporter (Drug/Vaccine) was Not Reported, for Blood cholesterol abnormal per reporter (Drug/Vaccine) was not assessable, for other events per reporter (Drug/Vaccine) was Not Related. Causality as per Mfr. (Drug/Vaccine) for Blood cholesterol abnormal was Reasonable possibility, for other events was no reasonable possibility. C  Causality of Pfizer Biontech Covid-19 Vaccine for Spinal laminectomy, Pain, Nerve root compression, Mobility decreased, Fatigue aggravated, Unable to walk as per reporter (Drug/Vaccine) was Not Reported; Causality as per reporter (Drug/Vaccine) for other events Not Related.  The reporter's assessment of the causal relationship of events for Spinal laminectomy, Pain, Nerve root compression, Mobility decreased, Fatigue aggravated, Unable to walk with the suspect product 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. No further information is expected.; Sender's Comments: Based on the current available information, the reported events (Spinal laminectomy, Pain, Nerve root compression, Mobility decreased, Fatigue aggravated, Unable to walk, Loss of energy, Nerve injury, Condition worsened, Leg discomfort, Leg pain, Nervous system disorder, and Blood cholesterol abnormal)  are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.