Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Heart rate increased, Hypersensitivity, Pericardial effusion, Pleural effusion, Rheumatoid arthritis
Clinical narrative: hospitalized for major rheumatoid flare up with allergy attack.; hospitalized for major rheumatoid flare up with allergy attack.; pericardial pleural effusion; abdominal pain; back pain; elevated heart rate walking increased heart rate; pericardial pleural effusion; shortness of breath; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4409495-00 (Agency).  A 60-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 13Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160362), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Humira suppressed immune system does not feel sounds normal/raspy voice", start date: 2020 (unspecified if ongoing); "Humira suppressed immune system does not feel sounds normal/raspy voice", start date: 2020 (unspecified if ongoing); "four sinus infections", start date: 2020 (unspecified if ongoing), notes: four sinus infections; "tested positive for allergies", start date: 2020 (unspecified if ongoing); "rheumatoid flare up with allergy attack", start date: 2020 (unspecified if ongoing), notes: In 2020, the patient experienced rheumatoid flare up with allergy attack; "rheumatoid flare up with allergy attack", start date: 2020 (unspecified if ongoing), notes: In 2020, the patient experienced rheumatoid flare up with allergy attack; "Unspecified headache" (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX taken for immunisation, start date: Aug2021, stop date: Aug2021. The following information was reported: RHEUMATOID ARTHRITIS (hospitalization), outcome "recovering", HYPERSENSITIVITY (hospitalization), outcome "unknown" and all described as "hospitalized for major rheumatoid flare up with allergy attack."; PERICARDIAL EFFUSION (medically significant), PLEURAL EFFUSION (non-serious), outcome "unknown" and all described as "pericardial pleural effusion"; ABDOMINAL PAIN (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "elevated heart rate walking increased heart rate"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: Echocardiogram: heart rate increase; Heart rate: Elevated. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "hospitalized for major rheumatoid flare up with allergy attack.", "pericardial pleural effusion", "abdominal pain", "back pain", "elevated heart rate walking increased heart rate" and "shortness of breath" 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. Solicited report by a consumer of a 58-year-old female with events of rheumatoid flare up with allergy attack and non-serious abdominal pain, back pain, elevated heart rate walking increased heart rate, Humira suppressed immune system does not feel sounds normal/raspy voice, pericardial pleural effusion, four sinus infections and tested positive for allergies with Humira (Adalimumab). There was no reported medical history .   On unknown dates, the patient experienced rheumatoid flare up with allergy attack, abdominal pain, back pain, elevated heart rate walking increased heart rate and pericardial pleural effusion. In 2020, the patient experienced rheumatoid flare up with allergy attack, Humira suppressed immune system does not feel sounds normal/raspy voice, four sinus infections and tested positive for allergies. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect.   In 2020, the patient had four sinus infections, tested positive for allergies. She had some unspecified headaches. Humira was suppressed her immune system did not felt her sounds normal, raspy voice. In Aug2021, she took Shingles vaccine. In May2022, she was hospitalized for major rheumatoid flare up with allergy attack. She administered steroids and she was become more immunosuppressed. She had abdominal pain, shortness of breath, back pain, elevated heart rate walking increased heart rate. She had pericardial pleural effusion and echocardiogram test. Unknown steroids considered as co suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab). The reporter's causality for the event(s) of rheumatoid flare up with allergy attack unknown onset with Humira (Adalimumab).was a reasonable possibility. The reporter's causality for the event(s) of rheumatoid flare up with allergy attack onset in 2020, abdominal pain, back pain, elevated heart rate walking increased heart, Humira suppressed immune system does not feel sounds normal/raspy voice onset in 2020, Humira suppressed immune system does not feel sounds normal/raspy voice onset in 2020, pericardial pleural effusion unknown onset, pericardial pleural effusion unknown onset, four sinus infections and tested positive for allergies was not provided. Agency's opinion is that there is no reasonable possibility that the events of rheumatoid flare up with allergy attack unknown onset, back pain and tested positive for allergies are related to Humira (Adalimumab). Agency's opinion is that the events of rheumatoid flare up with allergy attack onset in 2020, abdominal pain, back pain, elevated heart rate walking increased heart, pericardial pleural effusion unknown onset, pericardial pleural effusion unknown onset and four sinus infections are not assessable. Agency's opinion is that there is a reasonable possibility that the events of Humira suppressed immune system does not feel sounds normal/raspy voice onset in 2020 and Humira suppressed immune system does not feel sounds normal/raspy voice onset in 2020 are related to Humira (Adalimumab).; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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