Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Fall, Fatigue, Gait disturbance, Incontinence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 65-year-old female patient who received FLUARIX (batch number AFLUA709BA, expiry date 30th June 2013). The patient's past medical history included gastric disorder, arthritis and dermatomyositis (remission since before 1990). Previously administered products included DEXILANT (for over 10 years), lisinopril (for over 10 years), flu vaccine with an associated reaction of fatigue (at age 62, the patient reported, that she received flu vaccines yearly for approximately 5 to 7 years and felt tired for about a week after the vaccine), metformin with an associated reaction of abdominal pain upper (which became evident after the dose was increased from 500mg to 1000mg; patient discontinued metformin on her own), ONGLYZA with an associated reaction of abdominal pain upper and ONGLYZA with an associated reaction of chest pain (ONGLYZA was discontinued, and LANTUS was started). Concurrent medical conditions included type ii diabetes mellitus and drug allergy (formaldehyde and sulfur). Concomitant products included CELEBREX, LANTUS, DEXILANT, lisinopril, metformin and ONGLYZA. On 17th September 2012, the patient received the 1st dose of FLUARIX. On an unknown date, the dose was an unknown dose. In 2012, an unknown time after receiving FLUARIX, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant) and walking difficulty. In September 2012, the patient experienced tiredness. In October 2012, the patient experienced tingling. On 6th December 2012, the patient experienced pain (serious criteria hospitalization). On 17th December 2012, the patient experienced weakness (serious criteria hospitalization) and fall (serious criteria hospitalization). On 25th December 2012, the patient experienced stomach pain (serious criteria hospitalization). On 15th January 2013, the patient experienced incontinence. The patient was treated with hydrocodone and medication unknown (Drug Unspecified). FLUARIX was discontinued. On an unknown date, the outcome of the myelitis transverse and incontinence were not recovered/not resolved and the outcome of the weakness, tiredness and walking difficulty were resolved with sequelae and the outcome of the pain, fall and stomach pain were recovered/resolved and the outcome of the tingling was unknown. It was unknown if the reporter considered the myelitis transverse, weakness, pain, fall, stomach pain, tiredness, walking difficulty, incontinence and tingling to be related to FLUARIX. Additional details provided: Less than 1 week after the vaccination with FLUARIX, the patient was tired and dragging. On 25 September 2012, the patient went to primary care physician and was dismissed with only a flu shot test, revealing she did not have flu. The patient returned approximately 2 weeks later due to ongoing weakness, and a strange tingling that was occurring in the middle of her chest all the way to her back. Few weeks later the patient had become so weak that she could not open a door, wash dishes and was having difficulty walking. She also reports experiencing extreme pain, which she took hydrocodone for. Eventually, she discovered hydrocodone was causing a drop in her blood pressure, and it was discontinued. The patient was hospitalized for 10 days in December 2012. In January 2013, she began experiencing incontinence, and continues to experience it at time of report. She was eventually diagnosed with recurring transverse myelitis, which she describes as white matter in her spine, and reported two recurring episodes in 2014. Due to ongoing weakness, the patient continued to walk with a cane or walker, and experienced ongoing incontinence. Patient said she has reported the vaccine reaction to her doctor, and provides VAERS case ID# of 511788.