Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | OT |
Congestive heart failure; atrial fibrillation; dose 1 administred on 21Feb2021; dose 2 administered on 04Mar2021 for COVID-19 vaccination; This is a solicited report received from a Consumer or other non HCP. Other Case identifier(s): 846809 (Novo Nordisk Pharmaceuticals Inc. Mfr. Report#), S 20210902206 (Novo Nordisk Pharmaceuticals Inc.), IN20250215380 (Novo Nordisk Pharmaceuticals Inc.). An adult male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; insulin degludec (TRESIBA FLEXTOUCH), first regimen since 2020) and second regimen (Lot number: PZFAE39, Expiration Date: 30Jun2026) at 25 iU, all subcutaneous for diabetes mellitus. The patient's relevant medical history included: "Diabetes Mellitus" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, inrtamuscular), administration date: 21Feb2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Mar2021, outcome "unknown", described as "dose 1 administred on 21Feb2021; dose 2 administered on 04Mar2021 for COVID-19 vaccination"; CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant) with onset 07Apr2021, outcome "not recovered", described as "Congestive heart failure"; ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 07Apr2021, outcome "unknown". The patient was hospitalized for cardiac failure congestive, atrial fibrillation (start date: 07Apr2021). The action taken for insulin degludec was unknown. Therapeutic measures were taken as a result of cardiac failure congestive, atrial fibrillation. Clinical course: A consumer reported that on 18May2021, as treatment, the patient underwent pacemaker. On an unspecified date, as further treatment, the patient was hospitalized, underwent atrial fibrillation ablation, and was placed on a breathing machine due to complications of congestive heart failure during surgery. After the surgery, the patient went home on oxygen therapy. The reporter felt that the congestive heart failure and atrial fibrillation were related to therapy with Comirnaty. The reporter's causality for Tresiba FlexTouch U200 with the events congestive heart failure and atrial fibrillation was unlikely. The Company's causality for Tresiba FlexTouch U200 with the events congestive heart failure and atrial fibrillation was unlikely. Reporter Comment: Alternative etiology: The reporter felt that the congestive heart failure and atrial fibrillation were related to therapy with Comirnaty. Company comment: Cardiac failure congestive and atrial fibrillation are assessed as unlisted events according to (redacted) current reference safety information (CCDS) on Tresiba FlexTouch. Information on patient's relevant medical history of coronary disease or other cardiac disease, action taken to Tresiba, associated risk factors (immobilization. reduced cardiac output, surgery, trauma, malignant diseases, infections, dehydration, hypertensive episodes, previous thrombo-embolic events), results from clinical and laboratory investigations performed are not available for further medical assessment. However, the co-suspect, Comirnaty is considered as confounding factor in the case. Congestive cardiac failure could be secondary to atrial fibrillation in the case. Considering the pharmacological profile of the suspect drug and available information, congestive cardiac failure and atrial fibrillation are assessed to be unlikely related to Tresiba FlexTouch. This single case report is not considered to change the current knowledge of the safety profile of Tresiba Flex Touch. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reporter's Comments: Alternative etiology: The reporter felt that the congestive heart failure and atrial fibrillation were related to therapy with Comirnaty.; Sender's Comments: The events cardiac failure congestive, and atrial fibrillation are conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient such as diabetes mellitus and/or concomitant medication of INSULIN DEGLUDEC. 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.
Diabetes mellitus
TRESIBA FLEXTOUCH