Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Benign prostatic hyperplasia, Biopsy peripheral nerve, Blood test, Condition aggravated, Guillain-Barre syndrome
Clinical narrative: Initial information received regarding an unsolicited valid serious case received from a consumer (patient's wife) on 09-Aug-2018. This case involves a 69 years old male patient (190.5 cm and 92.53 kg) who experienced Chronic Guillain Barre syndrome while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing benign prostatic hyperplasia with BPH is getting worse which needed surgery this year (ongoing since 8 to 10 years). The patient's concomitant medications included ASPIRIN (E.C.) for cardiac health 81 mg daily started at least 10-12 years ago; SIMVASTATIN for Blood cholesterol increased at a daily dose of 200 mg; VITAMIN D3 for Compression fracture at a dose of 2000 IU once a day; TAMSULOSIN at a daily dose of 0.4 mg for Benign prostatic hyperplasia; PAXIL at a daily dose 40 mg from an unspecified date at 2016 to treat Panic attack; PRILOSEC at a daily dose of 40 mg to treat Gastritis; VITAMIN B1 NOS at a daily dose of 50 mg from Apr-2017 for nerve health; GABAPENTIN 800 mg thrice a day to treat Pain; MORPHINE 600 mg twice a day to treat Pain; OXYCODONE 10 mg thrice a day to treat Pain; VITAMIN B12 for unknown indication from 2016; VITAMIN C at a dose of 500 mg from 2017 for unknown indication; ZINC at a dose of 500 mg for unknown indication; PHENERGAN at a dose of 25 mg for unknown indication since 2015; and VENLAFAXINE  at a dose of 37.5 mg for unknown indication and LORATADINE at a dose of 5.0 mg for treating allergy. On an unspecified day at Oct-2013, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. The patient was also vaccinated with another dose of suspect at unspecified day at Oct-2014 at a local pharmacy. On an unknown date at Nov-2013, the patient developed a serious chronic inflammatory polyneuropathy disease, few-days following the administration of INFLUENZA VACCINE which was diagnosed by neurologists. This event was assessed as medically significant. It was reported that patient tried LYRICA about 2 years ago for pain. The physician tried something for couple of months but it built up in his brain and had seizure. Patient was taken to hospital and admitted for 5-6 days. Patient received GAVISCON for indigestion and loratadine as needed allergy. On an unknown date, the patient has performed multiple test by neurologist along a lumbar puncture, MRI's, blood work and a nerve biopsy. Results were not provided. Final diagnosis was BPH is getting worse and chronic Guillain Barre syndrome. The patient was treated with LYRICA for Guillain-Barre syndrome at a dose of 200 mg thrice daily and improvement can be seen. The patient outcome is reported as Not Recovered / Not Resolved for both the events. Sender's Comments: This case involves an elderly male patient who presented with Guillain-Barre syndrome and aggravation of benign prostatic hyperplasia after vaccination with Influenza vaccine (unknown manufacturer). Time to onset is not clearly mentioned. More details regarding patient's history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. There are multiple possible etiologies of Guillain Barre Syndrome and the causal relationship with the vaccine cannot be ascertained without ruling out the other causes of this event. Based on the available information, the role of vaccine cannot be assessed.