Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Plasmapheresis, Thrombosis, Ultrasound scan abnormal, Walking aid user
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) via Agency (Reference number: 18P-163-2321310-00) on 21-May-2018, concerning a 54-year-old, adult female patient. The patient was non-smoker and abstained from alcohol. The patient's historical drug included: TEGRETOL for an unknown indication. The patient's current condition included: hypertension. The patient was allergic to sulfa manifested by rash, TEGRETOL allergy manifested by rash, opioids and derivatives allergy manifested by rash. Concomitant medication included: Clonidine for hypertension. On an unspecified date in Nov-2016, the patient was administered with non-company suspect drug CREON (Pancreatin, 36000-unit, capsule) (3 capsules daily with meals and 1 capsule with snacks via oral route) for idiopathic pancreatic insufficiency. On 04-Oct-2017, the patient was administered with FLUVIRIN (route of administration: reported as injection, dose, anatomical location, batch number, expiry date: not reported). On an unspecified date in 2017, reported as two weeks later, the patient experienced numbness in her extremities that eventually worsened to her whole body. On 20-Dec-2017, after 2 months 17 days of vaccination, the patient was hospitalized for the symptoms and was diagnosed with chronic inflammatory demyelinating polyneuropathy. On an unspecified date in Dec-2017, lumbar puncture and nerve conduction study was done, results of which confirmed chronic inflammatory demyelinating polyneuropathy. The patient received plasmapheresis and intravenous globulin treatment during the hospitalization. On 25-Dec-2017, the patient was discharged from the hospital. The patient's numbness symptoms continued and was hospitalized from 09-Jan-2018 to 23-Jan-2018 for the same symptoms and was given a walker and cane for ambulation. However, the patient's symptoms did not improve and was re-hospitalized from 15-Feb-2018 to 08-Mar-2018 and received another plasmapheresis and intravenous immune globulin treatment. Later, the patient was transferred to another hospital for the final week of hospitalization. The patient's routine follow-up with physician noticed that her right leg was swollen. On an unspecified date, the patient was hospitalized. On 10-Apr-2018, after 6 months 7 days of vaccination, the patient's ultrasound of leg was performed which showed thrombosis in leg (final diagnosis). The patient was prescribed with ELIQUIS due to blood clot. No additional treatment for the blood clot was planned at that time. It was reported that, the patient was treated with Gabapentin, immune globulin, prednisone and ELIQUIS. At the time of this report, the patient had not yet recovered from the event inflammatory demyelinating polyradiculoneuropathy and was still recovering from the event thrombosis leg. The reporter considered the case as serious due to hospitalization and medically significant. The reporter considered the causality of the events as not related   [Due to memory limitations, the remainder of this text could not be compared.]  lated with suspect product CREON and related to suspect vaccine.