Sex: F
Vaccine: FLUX
Symptoms: Gastrooesophageal reflux disease, Hypersensitivity, Medication error, Nasal congestion, Product use issue
Clinical narrative: ASTHENIA; ASTHMA; ATRIAL FIBRILLATION; BACK PAIN; GASTROOESOPHAGEAL REFLUX DISEASE; HYPERSENSITIVITY; NASAL CONGESTION; TACHYCARDIA; WEIGHT DECREASED; PRODUCT USE ISSUE; A spontaneous report has been received by Takeda from the regulatory authority via Takeda Pharmaceuticals concerning a female patient of Unknown ethnic origin (age 72 years).    The patient's past and current medical history included nasal congestion (ongoing) and asthma (ongoing). Concomitant medication included paracetamol for product used for unknown indication.   On an unknown date, patient received Influenza Vaccine (influenza vaccines), via unk route, for prophylaxis.     On an unknown date,  patient started treatment with Candesartan (candesartan cilexetil) UNK, unk,  , with Omnaris (ciclesonide) UNK, unk,  for nasal congestion, with Lansoprazole (lansoprazole) UNK, unk,  for gastrooesophageal reflux disease, with Mepolizumab (mepolizumab) 100 mg every four weeks, subcutaneous,  for asthma, with Amitriptyline (amitriptyline hydrochloride) UNK, unk,  , with Betahistine (betahistine hydrochloride) UNK, unk  , with Cymbalta (duloxetine hydrochloride) UNK, unk,  , with Detrol (tolterodine l-tartrate) UNK, unk , with Fluticasone Propionate (fluticasone propionate) UNK, unk,  , with Gabapentin (gabapentin) 300 mg four times a day, unk,  , with Iron (ferrous sulfate) UNK, unk,  , with Lipitor (atorvastatin calcium) UNK, unk,  , with Metformin (metformin hydrochloride) 500 mg every 12 hours, unk,  , with Ropinirole Hydrochloride (ropinirole hydrochloride) UNK, unk,  , with Synthroid (levothyroxine sodium) UNK, unk,  , with Temazepam (temazepam) UNK, unk,  , with Tiotropium Bromide Monohydrate (tiotropium bromide monohydrate) 2 DF daily, unk,  , with Ventolin (salbutamol) UNK UNK, qd, unk,   and with Zenhale (formoterol fumarate, mometasone furoate) 2 DF every 12 hours, unk, for product used for unknown indication .    No malfunction has been reported for INFLUENZA VACCINE. No malfunction has been reported for OMNARIS.    The report described a medication error for Influenza Vaccine, Candesartan, Omnaris, Lansoprazole, Amitriptyline, Betahistine, Cymbalta, Detrol, Fluticasone Propionate, Gabapentin, Iron, Lipitor, Mepolizumab, Mepolizumab, Metformin, Ropinirole Hydrochloride, Synthroid, Temazepam, Tiotropium Bromide Monohydrate, Ventolin and Zenhale. The reported term was product use issue (Preferred term: Product use issue).     On an unknown date, the patient experienced asthenia (preferred term: Asthenia),asthma (preferred term: Asthma),atrial fibrillation (preferred term: Atrial fibrillation),back pain (preferred term: Back pain),gastrooesophageal reflux disease (preferred term: Gastrooesophageal reflux disease),hypersensitivity (preferred term: Hypersensitivity),nasal congestion (preferred term: Nasal congestion),tachycardia (preferred term: Tachycardia),weight decreased (preferred term: Weight decreased).     It was unknown if any action was taken with Influenza Vaccine , Candesartan , Omnaris , Lansoprazole , Amitriptyline , Betahistine , Cymbalta , Detrol , Fluticasone Propionate , Gabapentin , Iron , Lipitor , Mepolizumab , Mepolizumab , Metformin , Ropinirole Hydrochloride, Synthroid , Temazepam , Tiotropium Bromide Monohydrate , Ventolin  and Zenhale .     The outcome of the events of asthenia, asthma, atrial fibrillation, back pain, gastrooesophageal reflux disease, hypersensitivity, nasal congestion, tachycardia, weight decreased and product use issue was unknown.       The reporter assessed the events of asthenia, asthma, atrial fibrillation, back pain, gastrooesophageal reflux disease, hypersensitivity, nasal congestion, tachycardia and weight decreased to be serious due to seriousness criteria of important medical event while the event of product use issue is considered as non-serious.    The reporter considered that there was a reasonable possibility of a causal relationship between Omnaris  and the following event: atrial fibrillation, hypersensitivity, back pain, product use issue, gastrooesophageal reflux disease, nasal congestion, weight decreased, asthma, tachycardia and asthenia.       Report received by AstraZeneca/MedImmune via Takeda Pharmaceuticals on 26-MAR-2024.     Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA VACCINE  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: OMNARIS  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Corrected report on 29-Mar-2024:Regulatory Authority reporter and reference reporter added. Narrative updated.; Reporter's Comments: The reporter's causality assessment was not reported for the events with candesartan, Omnaris, influenza vaccine, lansoprazole and rest of all co suspects therapies.; Sender's Comments: This is a case of a 72 years female patient with reported 9 serious events in association with Q/LAIV, Candesartan takeda, ciclesonide (nasal) (omnaris). Events could be in association. Due to limited information on onset date and outcome of the events, treatment details, indication of all the suspects, etiological and diagnostic work up (blood workup, cardiac workup and imaging studies), the evaluation did not find evidence to suggest a causal relationship between individual events and suspect drugs. Case is confounded by polypharmacy.