Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Expired product administered, Fall, Guillain-Barre syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in 73-year-old female patient who received Flu trivalent vaccine. Co-suspect products included ADVAIR DISKUS inhalation powder (batch number 6ZP7427, expiry date 31st January 2018) for asthma. Concurrent medical conditions included blood pressure high, hypothyroidism, blood cholesterol increased, gout, asthma, clot blood, lymphedema and compression stockings application (she had to wear compression hose). Concomitant products included Levothyroxine, NEURONTIN, simvastatin, SINGULAIR, Warfarin, allopurinol, lisinopril and LASIX. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose and ADVAIR DISKUS (inhaled) 250/50 ug 1 puffs(s) twice daily (2 puff(s) daily). In December 2008, 28 days after receiving Flu trivalent vaccine and less than a month after starting ADVAIR DISKUS, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant) and paralysis (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced tingling (serious criteria hospitalization), fall (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), numbness (serious criteria hospitalization), feeling unwell, weakness, movements reduced and expired drug used. ADVAIR DISKUS was continued with no change. On an unknown date, the outcome of the Guillain Barre syndrome was resolved with sequelae and the outcome of the tingling, fall, balance difficulty, numbness, feeling unwell, weakness, movements reduced and expired drug used were unknown and the outcome of the paralysis was recovered/resolved. It was unknown if the reporter considered the Guillain Barre syndrome, tingling, fall, balance difficulty, paralysis, numbness, feeling unwell, weakness and movements reduced to be related to Flu trivalent vaccine. The reporter considered the Guillain Barre syndrome, tingling, fall, balance difficulty, paralysis and numbness to be unrelated to ADVAIR DISKUS. It was unknown if the reporter considered the feeling unwell, weakness and movements reduced to be related to ADVAIR DISKUS. Additional information was reported as follows: In 2006, the patient started taking ADVAIR DISKUS. The patient received the flu shot in November or December 2008. Soon after receiving the shot, she began to not feel well and fall sometimes because she was weak but did not think anything of it. Approximately 4 weeks after receiving the shot she had to be taken to the emergency room because she was paralyzed from the chest down. The patient was diagnosed with Guillain-Barre. The patient was unable to move but felt tingling and numbness in her body. The patient was in the hospital for a week to 10 days and then was discharged to a rehab facility. She was in rehabilitation for months. Approximately 3 years before the date of reporting, her physical therapist told her that she had reached the point where she would no longer make any more progress. She could use her upper body. From her knees down were still numb and tingly, causing her to had to look down at her feet regularly when she was walking because she might step on something, lose her balance, and fall. The patient knew she was using an expired ADVAIR DISKUS currently. The patient was counseled on the expiration date of the product. The patient had denied permission to contact their physician.