Age: 87.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Micrographia, Musculoskeletal stiffness, Nausea, Osteoporosis, Pain in extremity
Clinical narrative: Cogwheel rigidity; Micrographia; Limbs stiffness/ Stiff fingers; Hand pain; Joint pain; Parkinson's disease; Osteoporosis; Nausea; Back pain; Weakness; Hand swelling; Ruptured intervertebral disc; This is a solicited report from a contactable consumer (patient) collected based on the information received by Pfizer from AbbVie Inc. (MFR Control No. 21K-163-3913509-00).  This 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown) via intramuscular on 04Jan2021 (at the age of 87-year-old) at single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown) via intramuscular on 21Feb2021 (at the age of 87-year-old) at single dose, for COVID-19 immunisation. Co-suspect drug included upadacitinib (RINVOQ) taken orally from an unknown date for moderate to severe rheumatoid arthritis. Relevant medical history included lumbar spine compression fracture ongoing from Nov2020, moderate to severe rheumatoid arthritis and eczema. No relevant concomitant medications were provided. On unknown date, the patient experienced Parkinson's s disease, cogwheel rigidity (described as cog wheeling in left wrist), micrographia, limbs stiffness/ stiff fingers, hands pain, joint pain, osteoporosis (described as bone density issue), and nausea. On unknown date in 2021, the patient had hand swelling and in Jun2021 he had weakness. The clinical course was described as follows: In Nov2020, the patient experienced broken back/lumbar 4 fractures in spine. The patient broke his back, most recent fracture (Lumbar 4) in Nov or Dec 2020 and had surgery on it, and the only one he had since being on RINVOQ. He had been experienced back pain and said it could be related to age or the fact he had several fractures in his spine. He also had osteoporosis. He had been experiencing puffiness in his hands and back pain since past six weeks in 2021 and had been taking medication to improve his bone density, also his joint hurt and his fingers were stiff, especially in the mornings. In Mar 2021, he had back surgery to repair a ruptured disc. He was experiencing weakness in his legs. He saw a neurologist this morning who thought the weakness might be due to Parkinson's disease. Later he was diagnosed with Parkinson's disease.  The neurologist also found cog wheeling in his left wrist and micrographia. He had nausea, which he believed was being caused by the medication he had been given for Parkinson. He reported three weeks ago in Jun2021 he felt a weakness he thought was connected with the fracture in his back. Physician did not think the COVID vaccinations had been as effective because he was taking RINVOQ. Unknown Parkinson's medication was considered as co suspect.  Patient stated he doesn't think the COVID vaccinations have been as effective because patient was taking RINVOQ.  The reporter s causality for the events of broken back/lumbar 4 fractures in spine, ruptured disc, Parkinson's disease, cog wheeling in left wrist, micrographia, hands stiff, hands hurt, joint pain, weakness, puffiness in hands, stifness of finger, bone density issue/osteoporosis and nausea was not provided. The  Reporter's causality for the events of does not think the COVID vaccinations have been as effective because  patient was taking RINVOQ with upadacitinib (RINVOQ) was a reasonable possibility.   Abbvie's opinion is that there is no reasonable possibility that the events of broken back/lumbar 4 fractures in spine, ruptured disc, Parkinson's disease, cog wheeling in left wrist, micrographia, hands stiff, hands hurt, joint pain, weakness, puffiness in hands, stifness of finger, bone density issue/ osteoporosis and nausea are related to RINVOQ (upadacitinib). Abbvie s opinion is that the event of does not think the COVID vaccinations have been as effective because patient was taking RINVOQ is not assessable.  change history On 16Jun2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. the events of "micrographia", "broken back", "hands stiff", "hands hurt" and "nausea" were added. the event of "neurologist thought weakness in legs might be due to parkinson's disease" was amended to "Parkinson s disease". On 14Jul2021, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology and narrative description. The events of "back pain", "joint pain", "weakness", "puffiness in hands", "stifness of finger" and "bone density issue" were added. The event of "broken back" is now considered serious.  On 31Aug2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The event of "does not think the COVID vaccinations have been as effective because patient was taking rinvoq" was added.  the event of "broken back" was amended to "broken back/lumbar 4 fractures in spine".  The outcome of the events 'back pain' and 'hand swelling' was unknown. The outcome 'ruptured intervertebral disc', and 'weakness' was recovering. The outcome of the remaining events was not recovered.   The reporter considered there was no reasonably possibility that the events were related to upadacitinib (RINVOQ). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Parkinson's disease, Ruptured intervertebral disc, Cogwheel rigidity, Micrographia, Stiffness, Hand pain, Joint pain, Weakness, Hand swelling, Osteoporosis, Nausea, Back pain and suspect drug BNT162B2 cannot be excluded.