Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Chronic congestive heart failure; unspecified heart failure type (HCC)(HCC); Dilated cardiomyopathy; unable to tolerate betablocker; she is unable to afford given her financial situation; in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4; Anxiety; Depression/ Mild episode of recurrent major depressive disorder (HCC); Mild intermittent asthma without complication; Comprehensive metabolic panel (Resulted 4/16/2025, Abnormal); Encounter for long-term (current) use of medications 279.899; hypotension; RLS (restless legs syndrome); hypercholesterolemia; seasonal Allergies; Vit D Deficiency; A solicited report has been received from a physician in Patient Support Program. The report concerns a female adult patient (age 61 years, height 173 cm, weight 107 kg). The patient's past and current medical history included age related cataract in both eyes (started 04-FEB-2024), diverticulitis (started 04-FEB-2024), hematochezia (started 04-FEB-2024) and rheumatoid arthritis (dates not reported).Family history included hypertension and kidney disorder. No concomitant products were reported. The patient started treatment with Farxiga (dapagliflozin) UNK, Oral use, on an unknown date and with Influenza Vaccine (flumist, influenza virus vaccine polyvalent, q/laiv), on an unknown date. On an unknown date, the patient experienced she is unable to afford given her financial situation (preferred term: Inability to afford medication), chronic congestive heart failure (preferred term: Cardiac failure congestive), unable to tolerate betablocker (preferred term: Drug intolerance), hypotension (preferred term: Hypotension), dilated cardiomyopathy (preferred term: Dilated cardiomyopathy), unspecified heart failure type (hcc)(hcc) (preferred term: Cardiac failure), encounter for long-term (current) use of medications 279.899 (preferred term: Medication error), comprehensive metabolic panel (resulted 4/16/2025, abnormal) (preferred term: Metabolic function test), mild intermittent asthma without complication (preferred term: Asthma), hypercholesterolemia (preferred term: Hypercholesterolaemia), rls (restless legs syndrome) (preferred term: Restless legs syndrome), vit d deficiency (preferred term: Vitamin D deficiency), depression/ mild episode of recurrent major depressive disorder (hcc) (preferred term: Depression), anxiety (preferred term: Anxiety), seasonal allergies (preferred term: Seasonal allergy) and in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4 (preferred term: Pain). The report described a medication error for Farxiga. The reported term was encounter for long-term (current) use of medications 279.899 (preferred term: Medication error). It is unknown if any action was taken with Farxiga (dapagliflozin). The outcome of the event(s) of anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency was unknown. The following event(s) were considered serious due to medically significant:unspecified heart failure type (hcc)(hcc), chronic congestive heart failure and dilated cardiomyopathy. The following events were considered non-serious:anxiety, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker and vit d deficiency. The reporter did not assess causality for anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): unable to tolerate betablocker. The company physician did not consider that there was a reasonable possibility of a causal relationship between Farxiga and the following event(s): unable to tolerate betablocker. The company physician considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician considered that there was a reasonable possibility of a causal relationship between Farxiga and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician considered that there was a reasonable possibility of a causal relationship between Influenza Vaccine and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency. Device Information: Combination Product Report: Yes Product As Reported: Influenza Vaccine Brand Name: INFLUENZA VACCINE Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Summary of follow-up of information received by AstraZeneca on 25-APR-2025 from solicited source: patient's past and current medical history (age related cataract in both eyes (started 04-FEB-2024), diverticulitis (started 04-FEB-2024), hematochezia (started 04-FEB-2024) and rheumatoid arthritis (dates not reported), Family history (hypertension and kidney disorder) was added. Added new events of she is unable to afford given her financial situation, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, Anxiety, Depression, Mild intermittent asthma without complication, Comprehensive metabolic panel, Encounter for long-term (current) use of medications 279.899, Hypotension, RLS (restless legs syndrome), hypercholesterolemia, seasonal Allergies, Vit D Deficiency. Narrative updated.; Sender's Comments: Cardiac failure congestive, cardiac failure and dilated cardiomyopathy are not listed in the company core data sheet of dapagliflozin. Due to limited information on final outcome of event, start date of suspect drug, circumstances and details surrounding the event, event onset date, concomitant medications, possible risk factors, relevant medical history, treatment undertaken, clinical course, detailed etiologic and diagnostic workup the evaluation did not find evidence to exclude a reasonable possibility of a causal relationship between event and the suspect drug.
Medical History/Concurrent Conditions: Cataracts; Colonoscopy; Diverticulitis; Hematochezia; Hypertension; Kidney disorder; Penicillin allergy; Rheumatoid arthritis
Dapagliflozin