Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Gastrointestinal infection, Headache, Rheumatoid arthritis, Urinary tract infection
Clinical narrative: Atrial fibrillation; Rheumatoid arthritis; Two Urinary tract infection, Three Urinary tract infection; Infection in gut; Headache; FACILITATED COLLECT  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-163-4021918-00 (AbbVie).  A 81 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Feb2021 (Lot number: EL9267) at the age of 81 years as dose 2, single and intramuscular, administration date 01Jan2021 (Lot number: EL3249) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral since Mar2021 (Lot number: 1141368) at 7.5 mg and second regimen oral (Lot number: 1141368) at 15 mg (15 mg,1 in 2 d) for rheumatoid arthritis. Relevant medical history included: "Alcohol use/beer/former user", start date: 1995, stop date: 2000; "Tobacco use/Cigarette 1 pack a day/Former user", start date: 1955, stop date: 1986, notes: Ex-tobacco; "Heart attack", start date: 2021 (unspecified if ongoing); "Atrial fibrillation", start date: Mar2021 (unspecified if ongoing); "Lung issues" (unspecified if ongoing); "Breathing Issues" (unspecified if ongoing); "Chronic Gout" (unspecified if ongoing), notes: Chronic Gout; "Chronic pain disorder" (unspecified if ongoing), notes: Chronic pain disorder; "Renal failure" (unspecified if ongoing); "Dysphasia" (unspecified if ongoing); "Epigastric pain" (unspecified if ongoing); "Nausea" (unspecified if ongoing); "Interstitial Lung Disease" (unspecified if ongoing); "Urinary Tract Infection" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "HIgh Blood pressure" (unspecified if ongoing); "Nasal Cancer" (unspecified if ongoing), notes: Nasal Cancer; "Peptic Ulcer" (unspecified if ongoing); "Stent in Heart" (unspecified if ongoing), notes: Stent in Heart; "Neuropathy", start date: 2001 (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL taken for gout; ELIQUIS taken for cerebrovascular accident; PLAVIX; FUROSEMIDE; ISOSORBIDE; LINZESS; METFORMIN taken for diabetes mellitus; NITROSTAT; ZOFRAN [ONDANSETRON] taken for nausea; OXYCODONE taken for pain; PANTOPRAZOLE; ATORVASTATIN taken for blood cholesterol; PREDNISONE taken for inflammation; SOTALOL taken for hypertension; LOSARTAN. Past drug history included: Neomycin, reaction(s): "Rash". It was unknown if she was enrolled in a Covid-19 vaccine trial. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "recovering", described as "Atrial fibrillation"; RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "recovering", described as "Rheumatoid arthritis"; URINARY TRACT INFECTION (non-serious) with onset 2021, outcome "not recovered", described as "Two Urinary tract infection, Three Urinary tract infection"; GASTROINTESTINAL INFECTION (non-serious) with onset 2021, outcome "unknown", described as "Infection in gut"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "Headache". She had three urinary tract infection in Aug2021 and for a totally of five for this year in 2021. She had an infection in her gut and had been on antibiotic. She was off Rinvoq at this time. The patient underwent the following laboratory tests and procedures: urine analysis: (09Aug2021) unknown results. The action taken for upadacitinib was temporarily withdrawn. Therapeutic measures were taken as a result of gastrointestinal infection.  Causality for Rinvoq(Upadacitinib):  The reporter's causality for the event(s) of vaccine caused patient into atrial fibrillation, two urinary tract infection, three urinary tract infection, infection in gut, headache and rheumatoid arthritis symptoms was not provided.  1.) Urinary tract infection: Action(s) taken with drug: Drug discontinued; Dechallenge: Yes Causality as per reporter (Drug/Vaccine): Not assessable. Causality as per Mfr.(Drug/Vaccine): Reasonable possibility 2.) Headache, Rheumatoid arthritis, Gastrointestinal infection, Urinary tract infection, Atrial fibrillation. Action(s) taken with drug: Drug discontinued; Dechallenge: Yes Causality as per reporter (Drug/Vaccine): Not Reported. Causality as per Mfr.(Drug/Vaccine): No reasonable possibility  AbbVie's opinion is that there is no reasonable possibility that the events of vaccine caused patient into atrial fibrillation, headache and rheumatoid arthritis symptoms are related to Rinvoq(Upadacitinib). AbbVie's opinion is that there is a reasonable possibility that the events of two urinary tract infection, three urinary tract infection and infection in gut are related to Rinvoq(Upadacitinib).  Causality for Pfizer BioNTech Covid-19 Vaccine:  1)Atrial fibrillation: Causality as per reporter (Drug/Vaccine): Probable 2)Urinary tract infection, Urinary tract infection, Gastrointestinal infection, Headache, Rheumatoid arthritis: Causality as per reporter (Drug/Vaccine): Not Reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event Atrial fibrillation and the suspect drug BNT162B2  cannot be ruled out.  As there is limited information in the case provided, the causal association between the reported events Urinary tract infection, Gastrointestinal infection, Headache, Rheumatoid arthritis and the suspect drug BNT162B2 is assessed possibly unrelated . The case will be reassessed once new information (specific event dates) 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.