Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Food intolerance, Gastric disorder, Haemorrhoids, Heart rate, Heart rate increased
Clinical narrative: problem with hemorrhoids due to eating hot wings; problem with stomach; stiffness; fluid on lungs; fast heart rate; COPD/She had chronic obstructive pulmonary disease; COVID-19; COVID-19; diverticulitis; problem with hemorrhoids due to eating hot wings; after taking antibodies for Covid had bad reaction with fatigue and body ache; after taking antibodies for Covid had bad reaction with fatigue and body ache; 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): 21K-163-3942211-00.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Feb2021 (Batch/Lot number: unknown) at the age of 76 years as dose 2, single and intramuscular, administration date 12Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 115993) at (citrate free) for rheumatoid arthritis. Relevant medical history included: "Depression", start date: 2012 (unspecified if ongoing), notes: In 2012, the patient experienced DEPRESSION. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; DIVERTICULITIS (non-serious) with onset Nov2021, outcome "recovered", described as "diverticulitis"; HAEMORRHOIDS (non-serious), FOOD INTOLERANCE (non-serious), outcome "recovering" and all described as "problem with hemorrhoids due to eating hot wings"; GASTRIC DISORDER (non-serious), outcome "recovered", described as "problem with stomach"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered", described as "stiffness"; PLEURAL EFFUSION (non-serious), outcome "recovering", described as "fluid on lungs"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "recovering", described as "COPD/She had chronic obstructive pulmonary disease"; FATIGUE (non-serious), PAIN (non-serious) all with onset 2021, outcome "recovered" and all described as "after taking antibodies for Covid had bad reaction with fatigue and body ache". The patient underwent the following laboratory tests and procedures: heart rate: fast; sars-cov-2 test: positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of covid-19, diverticulitis.  The reporter considered "after taking antibodies for covid had bad reaction with fatigue and body ache" related to bnt162b2.  Clinical Information: On unknown dates, the patient experienced diverticulitis, problem with hemorrhoids due to eating hot wings, problem with stomach, stiffness, fluid on lungs, fast heart rate, COVID-19 and COPD. In 2012, the patient experienced depression. In 2021, the patient experienced after taking antibodies for covid had bad reaction with fatigue and body ache. On unknown dates, diverticulitis, problem with stomach, stiffness and after taking antibodies for covid had bad reaction with fatigue and body ache resolved. Pfizer biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect. The patient had ingrown hemorrhoids. In Nov2021, she had diverticulitis and diverticulosis surgery. After taking antibodies for covid had bad reaction with fatigue and body ache. She had chronic obstructive pulmonary disease. In Feb2021, patient received 1st and 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18Jan2022, received updates to patient demographics, event information, reporter opinion of causality, concomitant drug information, laboratory/diagnostic procedures and narrative description. The events of "problem with hemorrhoids due to eating hot wings", "problem with stomach", "depression", "fluid on lungs" and "COVID-19" were added. The event of "anxiety" was removed. On 22Mar2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "diverticulitis", "copd" and "after taking antibodies for covid had bad reaction with fatigue and body ache" were added.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of diverticulitis, problem with hemorrhoids due to eating hot wings unknown onset, problem with hemorrhoids due to eating hot wings unknown onset, problem with stomach, stiffness, depression, fluid on lungs, fast heart rate, covid-19, COPD, after taking antibodies for covid had bad reaction with fatigue and body ache onset in 2021 and after taking antibodies for covid had bad reaction with fatigue and body ache onset in 2021 with HUMIRA ADALIMUMAB) was no reasonable possibility. (Company name) opinion is that the events of diverticulitis, problem with stomach, fluid on lungs, fast heart rate and COPD are not assessable. Agency's opinion is that there is no reasonable possibility that the events of problem with hemorrhoids due to eating hot wings unknown onset, problem with hemorrhoids due to eating hot wings unknown onset, stiffness, depression, covid-19, after taking antibodies for covid had bad reaction with fatigue and body ache onset in 2021 and after taking antibodies for covid had bad reaction with fatigue and body ache onset in 2021 are related to HUMIRA(ADALIMUMAB).   The reporter's assessment of the causal relationship of the events with the suspect product was unknown at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.Based on the currently available information the possibility of causal association between the event fatigue and body ache and the suspect drug BNT162B2  cannot be ruled out. As there is limited information in the case provided, the causal association between the events diverticulitis, food intolerance, gastric disorder, pleural effusion, fast heart rate, COPD and the suspect drug BNT162B2 assessed unrelated.The case will be reassessed once new information is available.  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.