Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Peripheral swelling, Vision blurred, Weight
Clinical narrative: swelling in both legs and feet; congestive heart failure; Crohn's  flare up/Crohn's acting up; height shrunk; Dizziness; eye sight was not focusing together with Humira 40mg; This is a solicited report based on the information received by Pfizer. (MFR Control No. # 21K-163-3995267-00). A contactable physician and consumer reported that an 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, expiry date: 26Feb2021) via intramuscular on 26Feb2021 (at the age of 83-year-old) as dose 2, single for COVID-19 vaccination; Adalimumab (HUMIRA, Solution for injection in pre-filled pen, lot number: 1141161) from 2019 and ongoing at 40 mg via Subcutaneous for moderate to severe rheumatoid arthritis and celecoxib via an unknow route on an unknown date at an unknown dose and frequency for osteoarthritis. The patient medical history included thyroid, diuretic, supplement, overactive bladder, small intestine, general pain, arthritis, all were ongoing, congestive heart failure from 2017, non-smoker, abstains from alcohol, low iron levels. The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included levothyroxine for thyroid, furosemide for diuretic, potassium chloride for unknown indication, cobamamide (VITAMIN B12) for supplement, oxybutynin for overactive bladder, budesonide for small intestine, acetaminophen for general pain and arthritis. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: BM9809, expiration date: Jun2021) via intramuscular on 05Feb2021 (at the age of 83-year-old) as dose 1, single for COVID-19 vaccination. On unknown date in 2021, the patient experienced height shrunk and dizziness and the patient experienced eye sight was not focusing together with Humira 40mg. In Mar2021, the patient experienced Crohn's flare up/Crohn's acting up. In Jul2021, the patient experienced congestive heart failure. On 01Jul2021, the patient experienced swelling in both legs and feet. Pfizer covid-19 vaccine and Celecoxib were also considered suspect. The patient went to the emergency room and diagnosed with congestive heart failure and she believed this was related to Humira. In 2021, her eye sight had worsened and was advised to get new glasses. In Mar2021, her Crohn's disease flared up really bad after Covid 19 vaccine and felt extreme fatigue and loose stools, diarrhea. Her Crohn's had been acting up. She took Pepto Bismol and an over the counter anti diarrheal to help with her symptoms. She was concerned about weight loss, lost 10 lbs due to excessive diarrhea and was very upset. She gained 3 lbs in a week which in turn made her feel a lot better. Weight loss was improved and she weighed 101 lbs. In Jun2021, she had weight loss, her appetite went down, and felt very tired. In Jul2021, due to swelling in both legs and feet she went to emergency room and had electrocardiogram which had shown she had congestive heart failure. She was not hospitalized and had taken furosemide, wore compression stockings and had been advised to walk around. On unknown date in 2021, Her height had shrunken as she used to be sixty five inches tall. Outcome of the events of Crohn's disease, Body height decreased was unknown and other events was not recovered. The causality of the events of cardiac failure congestive, peripheral swelling, vision blurred, body height decreased, dizziness and Crohn's disease with respect to the suspect bnt162b2 was not related as per reporter (Drug/Vaccine). The causality of the events of cardiac failure congestive, peripheral swelling, vision blurred, body height decreased, dizziness with respect to the co-suspect Humira was not assessable per reporter and no reasonable possibility as per manufacturer; and for the event of Crohn's disease was no reasonable possibility per reporter and no reasonable possibility as per manufacturer. The causality of the events of peripheral swelling, vision blurred, body height decreased, dizziness and Crohn's disease with respect to the co-suspect celecoxib was not related as per reporter and for the event of cardiac failure congestive was Probable as per reporter.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Congestive heart failure, Crohn's disease, body height decreased, dizziness, peripheral swelling and vision blurred cannot be excluded.  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.