Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Full blood count increased, Joint swelling, Metabolic function test, Mycobacterium tuberculosis complex test
Clinical narrative: Swelling on knee; Pain on Right Knee; problem with urinating; Rheumatoid arthritis flare up; Full blood count increased; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-ABBVIE-22K-163-4476185-00.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1161756) till 2022 at 40 mg (40 mg, every 2 weeks) and second regimen since Jul2022 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg, every 7 days), all subcutaneous for rheumatoid arthritis; ibuprofen (IBUPROFEN), (Batch/Lot number: unknown) at 200 mg (200 mg, 2/days) for pain. The patient's relevant medical history included: "Supplementation therapy" (unspecified if ongoing); "Hysterectomy" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Cigarettes half a pack a day", start date: 1970, stop date: 2022, notes: Cigarettes half a pack a day; "Benign Fibroid Tumor on left Uterus" (unspecified if ongoing), notes: Patient mentioned that on her early 30's she had Benign Fibroid Tumor on her left Uterus. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single; METHOTREXATE; CALCIUM; POTASSIUM CHLORIDE; SIMVASTATIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; OMEGA 3 FISH OIL [FISH OIL] taken for supplementation therapy; FOLIC ACID taken for supplementation therapy.  The following information was reported: FULL BLOOD COUNT INCREASED (non-serious) with onset 29Sep2021, outcome "not recovered"; RHEUMATOID ARTHRITIS (medically significant) with onset Oct2021, outcome "unknown", described as "Rheumatoid arthritis flare up"; ARTHRALGIA (non-serious) with onset Jan2022, outcome "recovered", described as "Pain on Right Knee"; DYSURIA (non-serious) with onset 2022, outcome "recovered", described as "problem with urinating"; JOINT SWELLING (non-serious) with onset Jul2022, outcome "recovered", described as "Swelling on knee". The patient underwent the following laboratory tests and procedures: Anti-cyclic citrullinated peptide antibody: (2021) Unknown result; Blood test: (29Sep2021) Elevated; (29Dec2021) Elevated; (06Apr2022) Elevated; (01Jul2022) Elevated; (Sep2022) Normal; C-reactive protein: (29Sep2021) Unknown results; Full blood count: (2021) Unknown results; Full blood count increased: (unspecified date) Increased; Metabolic function test: (29Sep2021) Unknown results; Mycobacterium tuberculosis complex test: (29Sep2021) Unknown results; Red blood cell sedimentation rate: (29Sep2021) Unknown results; Rheumatoid factor: (29Sep2021) Unknown results; Ultrasound scan: (18Mar2022) Normal; (24Feb2022) Normal, notes: Ultrasound Outer part of Arm; X-ray limb: (24Feb2022) Normal. The action taken for adalimumab was dosage not changed.  Clinical course: The physician change Humira dosage from every two weeks because weekly was effective than biweekly dosage. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Causality Assessment for Humira: The reporter's causality for the event(s) of physician change humira dosage from every two weeks because weekly was effective than biweekly dosage and Rheumatoid arthritis flare up with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Full blood count increased, Pain on Right Knee, swelling on knee and problem with urinating with Adalimumab Solution for Injection was No Reasonable Possibility.  Causality Assessment for BNT162B2: The reporter's causality for the event(s) of physician change humira dosage from every two weeks because weekly was effective than biweekly DOSAGE with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was No Reasonable Possibility. The reporter's causality for the event(s) of Full blood count increased, Pain on Right Knee, Swelling on knee and problem with urinating with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Causality Assessment for Ibuprofen: The reporter's causality for the event(s) of Full blood count increased, physician change humira dosage from every two weeks because weekly was effective than biweekly dosage, Pain on Right Knee, Rheumatoid arthritis flare up, Swelling on knee and problem with urinating with Ibuprofen (Ibuprofen) was Not Provided RA's opinion was that the causality for the event(s) of Full blood count increased, physician change humira dosage from every two weeks because weekly was effective than biweekly dosage, Pain on Right Knee, Rheumatoid arthritis flare up, Swelling on knee and problem with urinating with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided RA's opinion was that the causality for the event(s) of Full blood count increased, physician change humira dosage from every two weeks because weekly was effective than biweekly dosage, Pain on Right Knee, Rheumatoid arthritis flare up, Swelling on knee and problem with urinating with Adalimumab Solution for Injection was Not Provided RA's opinion was that the causality for the event(s) of Full blood count increased, physician change humira dosage from every two weeks because weekly was effective than biweekly dosage, Pain on Right Knee, Rheumatoid arthritis flare up Swelling on knee and problem with urinating with Ibuprofen (Ibuprofen) was Not Provided  Assessment Results: PFIZER BIONTECH COVID-19 VACCINE Knee pain, Non-Health Care Professional, Global Introspection, Probable. PFIZER BIONTECH COVID-19 VACCINE Knee swelling, Market Authorization Holder (MAH). PFIZER BIONTECH COVID-19 VACCINE Knee swelling, Non-Health Care Professional, Global Introspection, Probable. PFIZER BIONTECH COVID-19 VACCINE Micturition disorder, Market Authorization Holder (MAH) PFIZER BIONTECH COVID-19 VACCINE Micturition disorder, Non-Health Care Professional, Global Introspection, Probable. HUMIRA 40MG/0.4ML Drug ineffective, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Knee pain, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Knee pain, Non-Health Care Professional, Global Introspection, Not Related. HUMIRA 40MG/0.4ML Knee swelling, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Knee swelling, Non-Health Care Professional, Global Introspection, Not Related. HUMIRA 40MG/0.4ML Micturition disorder, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Micturition disorder, Non-Health Care Professional, Global Introspection, Not Related. PFIZER BIONTECH COVID-19 VACCINE Rheumatoid arthritis flare up, Market Authorization Holder (MAH). PFIZER BIONTECH COVID-19 VACCINE Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML Rheumatoid arthritis flare up, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Not Reported. Ibuprofen Knee pain, Market Authorization Holder (MAH). Ibuprofen Knee pain, Non-Health Care Professional, Global Introspection, Not Reported. Ibuprofen Drug ineffective, Market Authorization Holder (MAH). Ibuprofen Drug ineffective, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML Full blood count increased, Market Authorization Holder (MAH). HUMIRA 40MG/0.4ML Full blood count increased, Non-Health Care Professional, Global Introspection, Not Related. Ibuprofen Full blood count increased, Market Authorization Holder (MAH). Ibuprofen Full blood count increased, Non-Health Care Professional, Global Introspection, Not Reported. Ibuprofen Knee swelling, Market Authorization Holder (MAH). Ibuprofen Knee swelling, Non-Health Care Professional, Global Introspection, Not Reported. PFIZER BIONTECH COVID-19 VACCINE Full blood count increased, Market Authorization Holder (MAH). PFIZER BIONTECH COVID-19 VACCINE Full blood count increased, Non-Health Care Professional, Global Introspection, Probable. Ibuprofen Rheumatoid arthritis flare up, Market Authorization Holder (MAH). Ibuprofen Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Not Reported. Ibuprofen Micturition disorder, Market Authorization Holder (MAH). Ibuprofen Micturition disorder, Non-Health Care Professional, Global Introspection, Not Reported.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "problem with urinating", "swelling on knee", "pain on right knee" and "full blood count increased" 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.  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 available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  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.