Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Eye disorder, Fall, Fatigue, Fibromyalgia
Clinical narrative: eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints; affects eyes; right after the covid vaccine started feeling tired; right after the covid vaccine started feeling slow and sluggish; Hard to get up; inflammation on hip; fell; right after covid vaccine started feeling stuffy nose; Fibromyalgia was flaring up; stiffness and more pain in joints muscles before time for next HUMIRA injection; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4502759-00.  A 54-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg, subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: IMURAN [AZATHIOPRINE]. The following information was reported: FIBROMYALGIA (non-serious) with onset 26Sep2022, outcome "unknown", described as "Fibromyalgia was flaring up"; MOBILITY DECREASED (non-serious) with onset 26Sep2022, outcome "unknown", described as "Hard to get up"; EYE DISORDER (non-serious) with onset 26Sep2022, outcome "unknown", described as "affects eyes"; RHEUMATOID ARTHRITIS (medically significant) with onset 26Sep2022, outcome "unknown", described as "eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints"; FALL (non-serious) with onset 26Sep2022, outcome "unknown", described as "fell"; ARTHRITIS (non-serious) with onset 26Sep2022, outcome "unknown", described as "inflammation on hip"; NASAL CONGESTION (non-serious) with onset 26Sep2022, outcome "unknown", described as "right after covid vaccine started feeling stuffy nose"; SLUGGISHNESS (non-serious) with onset 26Sep2022, outcome "unknown", described as "right after the covid vaccine started feeling slow and sluggish"; FATIGUE (non-serious) with onset 26Sep2022, outcome "unknown", described as "right after the covid vaccine started feeling tired"; THERAPEUTIC RESPONSE SHORTENED (non-serious) with onset 26Sep2022, outcome "unknown", described as "stiffness and more pain in joints muscles before time for next HUMIRA injection". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of rheumatoid arthritis, eye disorder.  Clinical Course: Solicited report from PRIVATE by a consumer of a 54-years-old female with events of non-serious Fibromyalgia was flaring up, eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints, right after covid vaccine started feeling stuffy nose, inflammation on hip, fell, Hard to get up, right after the covid vaccine started feeling slow and sluggish, right after the covid vaccine started feeling tired, and stiffness and more pain in joints muscles before time for next HUMIRA injection with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On 26Sep2022, the patient experienced fell. Pfizer BioNTech COVID-19 vaccine was also considered suspect. The patient had used two different eye drops for flare up in eyes and had taken steroid injections shot for both knee and hip. Treatment Drugs. The patient was treated with Prednisone.  The reporter's assessment of the causal relationship of "eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints", "affects eyes", "right after the covid vaccine started feeling tired", "right after the covid vaccine started feeling slow and sluggish", "hard to get up", "inflammation on hip", "fell", "right after covid vaccine started feeling stuffy nose", "fibromyalgia was flaring up" and "stiffness and more pain in joints muscles before time for next humira injection" with the suspect product(s) 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.   Causalities: The reporter's causality for the event(s) of right after covid vaccine started feeling stuffy nose, right after the covid vaccine started feeling slow and sluggish and right after the covid vaccine started feeling tired with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Fibromyalgia was flaring up, Hard to get up, eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints, fell, inflammation on hip and stiffness and more pain in joints muscles before time for next HUMIRA injection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  The reporter's causality for the event(s) of Fibromyalgia was flaring up and eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of Hard to get up, fell, inflammation on hip, right after covid vaccine started feeling stuffy nose, right after the covid vaccine started feeling slow and sluggish, right after the covid vaccine started feeling tired and stiffness and more pain in joints muscles before time for next HUMIRA injection with Adalimumab Solution for Injection was Not Provided.  Regulatory Authority opinion was that the causality for the event(s) of Fibromyalgia was flaring up, Hard to get up, eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints, fell, inflammation on hip, right after covid vaccine started feeling stuffy nose, right after the covid vaccine started feeling slow and sluggish, right after the covid vaccine started feeling tired and stiffness and more pain in joints muscles before time for next HUMIRA injection with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Regulatory Authority opinion was that the causality for the event(s) of Fibromyalgia was flaring up, Hard to get up, eye involvement juvenile rheumatoid arthritis/ affects eyes and joints / flare up of eye and joints, fell, inflammation on hip, right after covid vaccine started feeling stuffy nose, right after the covid vaccine started feeling slow and sluggish, right after the covid vaccine started feeling tired and stiffness and more pain in joints muscles before time for next HUMIRA injection with Adalimumab Solution for Injection was Not Provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.