Age: 44.0
Sex: F
Vaccine: COVID19, UNK, VARZOS
Symptoms: Back disorder, Drug ineffective, Fibromyalgia, General physical health deterioration, Herpes zoster
Clinical narrative: Rheumatoid arthritis; Lack of drug effect; Pain in hand; Hands weakness of; Product use for unapproved combination; Shingles; Musculoskeletal disorder; Musculoskeletal stiffness; Back disorder; Fibromyalgia; General physical health deterioration; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4165712-00 (Agency).  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Nov2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single, intramuscular, administration date 18Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), administration date 11Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for varicella immunisation; upadacitinib (RINVOQ), oral since Aug2021 (ongoing) (Batch/Lot number: unknown) at 15 mg (extend release (15 mg, 1 in 1 once)) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis"; DRUG INEFFECTIVE (non-serious), outcome "not recovered", described as "Lack of drug effect"; HERPES ZOSTER (non-serious) with onset Nov2021, outcome "unknown", described as "Shingles"; MUSCULOSKELETAL DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Musculoskeletal disorder"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "Musculoskeletal stiffness"; BACK DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Back disorder"; FIBROMYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Fibromyalgia"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset 2021, outcome "unknown", described as "General physical health deterioration"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in hand"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Hands weakness of"; PRODUCT USE ISSUE (non-serious) with onset 11Nov2021, outcome "unknown", described as "Product use for unapproved combination". The patient underwent the following laboratory tests and procedures: investigation: (2021) 10/100; pain assessment: (2021) 2/10. The action taken for upadacitinib was dosage not changed. Clinical course was reported as, the patient reported that pain was two out of ten since started therapy in Aug2021. Self health assessment score was ten out of hundred worsened since started therapy. Morning stiffness turn around and lasts five minutes, improved since started therapy. She had fibromyalgia, chronic back problems that effects feet and she was unable to tell which condition caused her pain, no improvement in symptoms since start of therapy. She had a rash on her left ankle that caused a burning pain and started seven weeks ago in Nov2021. She was told by her primary physician this might be shingles. Numbness and tingling in her hands occurred the day after strenuous activity, onset unknown. Preexisting back pain and fibromyalgia symptoms ongoing an unchanged. Morning stiffness reported to last 40 minutes, previously reported to last five min. Her morning stiffness was not worse, that time she was including stiffness in her back. She had saw no improvement in rheumatoid arthritis since starting RINVOQ. She continued to had tingling, weakness in her hands. She also had pain in her hands when she was actively using her hands. She felt had shingles on ankle, Her pain specialist said 99 percent certain it was shingles. She had shingles vaccination the same day, she had her Pfizer booster on 11Nov2021, shingles was only adverse event which was possibly associated with covid booster, reported that the patient received SHINGRIX vaccine. No Improvement in Rheumatoid Arthritis Since Starting Rinvoq and Shingles on Ankle with RINVOQ (UPADACITINIB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for BNT162B2: The reporter considered "shingles" related to bnt162b2, reported as relatedness of Shingles to bnt162b2 was Possible; and the reporters assessment for the causal relationship of the other events 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.  Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of Morning Stiffness/Stiffness in Back, Self Health Assessment Score Ten Out of Hundred, Fibromyalgia, Chronic Back Problems That Effects Feet onset in 2021, Chronic Back Problems That Effects Feet onset in 2021, Weakness in Hands, Pain in Hands and Shingles on Ankle, Product use for unapproved combination was not provided. The reporter's causality for the event(s) of No Improvement In Rheumatoid Arthritis Since Starting Rinvoq unknown onset and No Improvement In Rheumatoid Arthritis Since Starting Rinvoq unknown onset with RINVOQ (UPADACITINIB) was a reasonable possibility.  Causality for SHINGRIX: The reporter's causality for all the event(s) to SHINGRIX was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current information available, the event Rheumatoid arthritis mostly represented intercurrent condition in this patient unrelated to BNT162B2.