Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Gait disturbance, General physical health deterioration, Haemorrhage, Headache
Clinical narrative: Osteoarthritis; Plantar fasciitis; Unable to eat; Weight loss; problems in washing/dressing; problems in bending to shave legs; problems in/out bathtub; jaw locked; Stiffness shoulder; congestion possibly sinus related/sinus issues attributes to allergies; sinus issues attributes to allergies; problem with walking; Sinus infection; body aches; right shoulder joint stiffness; right shoulder joint swollen; ribs hurt; bruise on chest; red knot at the injection site; Stress at work/ Weight loss/ Joint stiffness/ Joint swelling; red knot at the injection site; Headache; right shoulder joint pain/pain in shoulder; Palindromic rheumatism; Stress at work; Chills; headaches due to aneurysm; problem with bleeding if bumped; Discomfort; Muscle ache; rheumatoid arthritis flare in jaw/flare elbows, wrist, discomfort, muscle aches, left wrist/hand mild; Shortness of breath; Chronic venous insufficiency; problem performing usual activities; rates overall health 35/100/overall health 35/100 due to comorbidities; skin was thin; Multimorbidity; Anxiety; Depression; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 20K-163-3712048-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; methylprednisolone (MEDROL [METHYLPREDNISOLONE]) (Batch/Lot number: unknown); adalimumab (HUMIRA), subcutaneous since 15Dec2020 (Batch/Lot number: unknown) at 40 mg (40 mg 1 in 2 week) for rheumatoid arthritis. Relevant medical history included: "FATIGUE" (unspecified if ongoing); "GENERALLY NOT FEELING WELL" (unspecified if ongoing); "WATER RETENTION LEGS,HANDS" (unspecified if ongoing); "HEADACHE" (unspecified if ongoing); "CEREBRAL ANEURYSM" (unspecified if ongoing); "SHOULDER STIFFNESS DUE TO INJURY" (unspecified if ongoing); "BACK TROUBLE RESULTING IN INFLEXIBILITY" (unspecified if ongoing); "CHRONIC VENOUS INSUFFICIENCY" (unspecified if ongoing); "SHORTNESS OF BREATH" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTRACRANIAL ANEURYSM (medically significant) with onset Dec2020, outcome "not recovered", described as "headaches due to aneurysm"; HAEMORRHAGE (medically significant) with onset Dec2020, outcome "unknown", described as "problem with bleeding if bumped"; PALINDROMIC RHEUMATISM (medically significant) with onset Apr2021, outcome "recovered" (2021), described as "Palindromic rheumatism"; RHEUMATOID ARTHRITIS (medically significant) with onset Dec2020, outcome "recovered" (2021), described as "rheumatoid arthritis flare in jaw/flare elbows, wrist, discomfort, muscle aches, left wrist/hand mild "; DYSPNOEA (non-serious) with onset Dec2020, outcome "not recovered", described as "Shortness of breath"; PERIPHERAL VENOUS DISEASE (non-serious) with onset Dec2020, outcome "not recovered", described as "Chronic venous insufficiency"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Dec2020, outcome "not recovered", described as "problem performing usual activities"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Dec2020, outcome "not recovered", described as "rates overall health 35/100/overall health 35/100 due to comorbidities"; SKIN ATROPHY (non-serious) with onset Dec2020, outcome "unknown", described as "skin was thin"; MULTIMORBIDITY (non-serious) with onset Dec2020, outcome "unknown", described as "Multimorbidity"; STRESS AT WORK (non-serious) with onset 29Dec2020, outcome "not recovered", described as "Stress at work"; OSTEOARTHRITIS (non-serious), outcome "not recovered", described as "Osteoarthritis"; PLANTAR FASCIITIS (non-serious), outcome "recovered", described as "Plantar fasciitis"; FEEDING DISORDER (non-serious), outcome "unknown", described as "Unable to eat"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "Weight loss"; IMPAIRED SELF-CARE (non-serious), outcome "unknown", described as "problems in washing/dressing"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "problems in bending to shave legs"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "problems in/out bathtub"; TRISMUS (non-serious), outcome "unknown", described as "jaw locked"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "Stiffness shoulder"; ANXIETY (non-serious) with onset Dec2020, outcome "unknown", described as "Anxiety"; DEPRESSION (non-serious) with onset Dec2020, outcome "unknown", described as "Depression"; SINUS CONGESTION (non-serious), outcome "not recovered", described as "congestion possibly sinus related/sinus issues attributes to allergies"; ALLERGIC SINUSITIS (non-serious), outcome "not recovered", described as "sinus issues attributes to allergies"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "problem with walking"; SINUSITIS (non-serious), outcome "unknown", described as "Sinus infection"; PAIN (non-serious), outcome "unknown", described as "body aches"; JOINT STIFFNESS (non-serious), outcome "not recovered", described as "right shoulder joint stiffness"; JOINT SWELLING (non-serious), outcome "not recovered", described as "right shoulder joint swollen"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "not recovered", described as "ribs hurt "; CONTUSION (non-serious), outcome "not recovered", described as "bruise on chest "; VACCINATION SITE NODULE (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "red knot at the injection site " and it was sore and hot with Humira 40mg/0.4ml (adalimumab); CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Stress at work/ Weight loss/ Joint stiffness/ Joint swelling"; DISCOMFORT (non-serious) with onset Dec2020, outcome "recovered", described as "Discomfort"; MYALGIA (non-serious) with onset Dec2020, outcome "recovered", described as "Muscle ache"; CHILLS (non-serious) with onset 28Dec2020, outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; ARTHRALGIA (non-serious), outcome "not recovered", described as "right shoulder joint pain/pain in shoulder". The patient underwent the following laboratory tests and procedures: cardiac function test: (unspecified date) normal limit; investigation: (Dec2020) 35/100; ultrasound doppler: (unspecified date) swelling in legs, notes: Swelling in legs due to chronic venous insufficiency; weight: (unspecified date) normal; (unspecified date) lost 10 pounds. The action taken for methylprednisolone and adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of the suspect product Pfizer biontech covid-19 vaccine with the events plantar fasciitis and red knot at the injection site was no reasonable possibility; for events palindromic rheumatism and right shoulder joint pain/pain in shoulder it was reasonable possibility; for the rest of the events it was not reported. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's assessment of the causal relationship of the suspect product Humira (adalimumab) with the event palindromic rheumatism and right shoulder joint pain/pain in shoulder was a reasonable possibility; for the rest of the events it was no reasonable possibility.   The reporter's assessment of the causal relationship of the suspect product Medrol (methylprednisolone acetate) with the events plantar fasciitis and red knot at the injection site was no reasonable possibility; for events palindromic rheumatism and right shoulder joint pain/pain in shoulder it was reasonable possibility; for the rest of the events it 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: The impact of this report on the benefit/risk profile of the Pfizer product 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.