Sex: F
Vaccine: FLUX
Symptoms: Amylase, Biopsy pancreas, Endoscopy biliary tract, Full blood count, Imaging procedure
Clinical narrative: PANCREATITIS; LAIV GIVEN OUTSIDE OF APPROVED AGE; A spontaneous report has been received from a consumer concerning a female patient of Unknown ethnic origin (age 71 years, weight 155 lb).    The patient's past and current medical history included appendicectomy (dates not reported), drug hypersensitivity (dates not reported), psoriasis (dates not reported), turbinectomy (dates not reported), diabetes mellitus (dates not reported), cardiac pacemaker insertion (dates not reported), back pain (dates not reported), psoriatic arthropathy (dates not reported), hypertension (dates not reported), hyperlipidaemia (dates not reported), peripheral swelling (dates not reported) and osteomyelitis (dates not reported).     Concomitant medication included metformin for diabetes mellitus, glimepiride for diabetes mellitus, losartan for hypertension and gabapentin for hypertension.     On 16-Sep-2022, the patient received Influenza Vaccine (influenza vaccine), via nasal route, for influenza (immunisation).     During 2019, the patient started treatment with Rosuvastatin (rosuvastatin calcium) 5 mg daily, oral, for hyperlipidaemia.     No malfunction has been reported for INFLUENZA VACCINE.    The report described a medication error for Influenza Vaccine. The reported term was laiv given outside of approved age (Preferred term: Product administered to patient of inappropriate age).    On 26-Jan-2023, the patient experienced pancreatitis (preferred term: Pancreatitis).     Treatment with Rosuvastatin was not changed. It was unknown if any action was taken with Influenza Vaccine.     At the time of reporting, the event pancreatitis was improving.    The reporter assessed the event of pancreatitis to be serious due to seriousness criteria hospitalisation.  The company physician assessed the event of laiv given outside of approved age as non-serious.    The reporter considered that there was a reasonable possibility of a causal relationship between Rosuvastatin and the following event(s): pancreatitis.     Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA VACCINE  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Pancreatitis is not listed in the company core data sheet of Q/LAIV. Underlying diabetes mellitus, hyperlipidemia, hypertension, and advanced age of patient could be possible risk factors to the event. Due to limited information on circumstances leading to the event, action taken with Q/LAIV,  final outcome of the event, risk factors (infection, gallstone disease, alcohol use, smoking, obesity), other medical history ( bile duct stenosis, hepatitis), concurrent diseases, other concomitant medications, family history of pancreatitis, clinical course, treatment details, detailed etiological, diagnostic workup as clinical examination, complete blood work (including pancreatic enzymes as amylase/lipase, inflammatory markers),imaging studies, hepatobiliary endoscopy, pancreatic biopsy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the event and Q/LAIV.