Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Diabetic gastroenteropathy, Gastrointestinal disorder, Hypoglycaemia
Clinical narrative: DIABETIC GASTROENTEROPATHY; GASTRIC DISORDER; HYPOGLYCAEMIA; A spontaneous report has been received from Health Professional via the regulatory authority concerning a female patient of Unknown ethnic origin (age 66 years, weight 83 kg).    No medical history was reported.     No concomitant products were reported.    On an unknown date, the patient received Influenza Vaccine (influenza vaccine) once/single administration, via intramuscular route, for antiviral prophylaxis.     The patient started treatment with Semaglutide (semaglutide) 0.5 mg once a week, subcutaneous, on an unknown date for type 2 diabetes mellitus.     No malfunction has been reported for INFLUENZA VACCINE.    On an unknown date, the patient experienced diabetic gastroenteropathy (preferred term: Diabetic gastroenteropathy). On an unknown date, the patient experienced gastric disorder (preferred term: Gastric disorder). On an unknown date, the patient experienced hypoglycaemia (preferred term: Hypoglycaemia).     It was unknown if any action was taken with Influenza Vaccine and Semaglutide.    The patient recovered with sequelae from the event(s) of diabetic gastroenteropathy, gastric disorder and hypoglycaemia on an unspecified date.     The reporter considered the events diabetic gastroenteropathy, gastric disorder and hypoglycaemia as serious due to hospitalization.     For regulatory reporting purposes, if an event is spontaneously reported, at least a reasonable possibility of a causal relationship is implied by the reporter, even if the relationship is unknown or unstated.    Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA VACCINE  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 04-Oct-2023: Hospitalization Required or Prolonged Hospitalization selected in association with each event with serious criteria hospitalization. reporter type of Patient added. Null flavors for all events and reporters added. Narrative amended.    Minor correction on 04-Oct-2023: Vaccination facility selected for suspect influenza vaccine.  Narrative amended.; Sender's Comments: Diabetic gastroenteropathy, gastric disorder and hypoglycaemia are not listed in the company core data sheet of Q/LAIV. The patient`s underlying type 2 diabetes mellitus could possibly be confounding to hypoglycaemia and Diabetic gastroenteropathy, which could be further confounding to gastric disorder. However, due to limited information on circumstances leading to the events, onset date of the events,  start date of the suspect drug, action taken with the suspect drug, concurrent conditions (gastrointestinal diseases), concomitant medications (insulin use), relevant medical history, risk factors leading to the events (alcohol use, inappropriate carbohydrate intake, infectious diseases, inappropriately prepared or stored food items), detailed etiological and diagnostic workup (complete blood analysis including infectious disease and glycemic profile, abdominal imaging studies, gastrointestinal endoscopy), the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the events and suspect drug.