Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Disability, Electromyogram, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Based on additional information received on 26 February 2016, this case initially considered as non-serious was upgraded to serious due to seriousness criteria: disability. Initial unsolicited report received from a consumer on 18 January 2016. This case involves 72-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number not reported) intramuscularly in the right deltoid on 18 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported and she had no illness at time of vaccination. The patient's concomitant medications were not provided. On 24 October 2015, six days following the vaccination, the patient had experienced numbness, pins and needles feeling, burning type pain in her right leg from the knee to toes and foot drop on the right foot. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received physical therapy as corrective treatment. The outcome of events was reported as not recovered. Follow up information received from a consumer on 26 February 2016 and additional information received on 03 March 2016. Batch number was updated as UI481AA. Pre-existing physician-diagnosed allergies, birth defects, and medical conditions was reported as scleroderma (crest), gastroesophageal reflux disease (GERD), Esophageal Cancer, hypothyroid. The patient did not experience any adverse event prior to vaccination. She did not receive any other vaccinations within 4 weeks prior to date of vaccination. Concomitant medications included Anastrozole 1 mg daily, Calcium 1200 mg daily with "vitamin D", Cyclobenzaprine 5 mg with at bed time, Prolia 60 mg for 6 month "for 6 MO", Furosemide 40 mg daily as needed, Levothyroxine 125 mcg daily, Omeprazole 40 mg daily, Ranitidine 150 mg daily at bed time, Tramadol 5 mg "as needed" pain, Temazepam 15 mg as needed for sleep, sucralfate four times a day. On 29 October 2015, 10 days following the vaccination, the patient had experienced numbness and foot drop. It was reported that, permanent disability resulted on 21 February 2016 and by the time of reporting, patient still had a problem. The patient had a doctor visit on 28 October 2015, she visited a neurologist on 30 Nov 2015, a neurosurgeon on 02 December 2015 and began physiotherapy. Laboratory data included brain MRI (On 02 November 2015), Spine MRI, lower extremity with Doppler, Ultrasound RT. On 10 December 2015, Electromyography was performed. The patient had not recovered from foot drop and numbness. List of documents held by sender: none. Sender's Comments: Foot drop is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE whereas numbness, burning leg and tingling is listed. Time to onset seems to be compatible with a role of the vaccination. Complementary information regarding the patient's condition at the time of the events, medical history and investigations exploring alternative etiologies are needed to further assess the case.