Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, General physical health deterioration, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Case number PHEH2015US027094, is an initial spontaneous report received from a consumer on 23 Dec 2015. This report refers to a 45 years old female patient. Family history included as father (72 years old) had high cholesterol, renal cancer, prostate cancer and hypertension. Patient mother (65 years old) had cancer. The patient underwent appendectomy (1989). Patient husband underwent vasectomy in 1999. The patient historical condition included last period occurred on 01 Jul 2013, 12 menarche. Patient was smoker (less than 1 pack per day). Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (manufacturer unknown and batch number: not reported) at a dose of 1 DF (reported as 0.5 mg) intramuscularly on 09 Oct 2015. On 10 Oct 2015, the patient experienced numbness and pain to left side of face, neck and arm. On the next day, the patient experienced numbness and pain to left leg. Approximately 2 weeks after vaccination, the patient experienced numbness and pain to all extremities including joint pain. Blood tests, magnetic resonance imaging (MRI) of brain and C spine were unremarkable. Electromyography (EMG) showed increased weakness. It was reported that due to these suspected symptoms the physician diagnosed the patient with Atypical Guillain Barre Syndrome. On an unknown date, the patient experienced paraesthesias in extremities. The patient lumbar puncture had been examined and had weakness and painful paraesthesias of both legs, chronic inflammatory demyelinating polyneuropathy (CIDP). The patient had immunoglobulins total over 03 days with transient improvement of symptoms. It was stated that, present symptomatology primarily in legs and shoulder regions and she started LYRICA at high dose. The patient was treated with gabapentin (manufacturer unknown) for numbness with no relief, painful paraesthesias and intravenous immunoglobulins (IVIG) on 21 Dec 2015, tramadol HCL (manufacturer unknown), nortriptyline HCL (manufacturer unknown) and FETZIMA. The outcome of chronic inflammatory demyelinating polyneuropathy and painful paraesthesias of both legs was not reported and rest of events was reported as condition deteriorating. Seriousness of the events was not reported. The causality of chronic inflammatory demyelinating polyneuropathy and painful paraesthesias of both legs was not reported and rest of events was reported as suspected. Seriousness of the event Guillain Barre syndrome was upgraded based on the Novartis important medical events list. Seriousness of chronic inflammatory demyelinating polyradiculoneuropathy was upgraded to medically significant based on the NVS IME list. Seriousness of paraesthesia was upgraded to medically significant based on the information available in the source document. Follow up report received from a physician on 02 Feb 2016: Added family history, medical history, events (painful paraesthesias of both legs and chronic inflammatory demyelinating polyneuropathy) and treatment medications (LYRICA, tramadol HCL, nortriptyline HCL and FETZIMA).