Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Myelitis transverse, Nerve conduction studies, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Initial case received from a healthcare professional on 17 October 2014. A 30 year old female patient was vaccinated with FLUZONE QIV, batch number UI158AB, into the left deltoid on 02 October 2014. The patient had not received any other vaccinations within four weeks of vaccination and was not ill at the time of vaccination. She had no known allergies or physician diagnosed medical conditions. The subject had received FLUZONE QIV in the past, batch number and date of administration were not reported. On 08 October 2014 in the morning, six days after vaccination, the patient experienced numbness and tingling in her heels. She did not do anything about the issue. On 13 October 2014, eleven days post vaccination, she developed numbness and tingling to her bilateral lower extremities. She went to the emergency room and was referred to a neurologist who performed a lumbar puncture with cultures on 14 October 2014 to rule out Guillain-Barre Syndrome. The results are still pending at the time of this report. Other testing is unknown. The patient outcome is not recovered. Upon internal review on 03 December 2014 it was determined that this event had been initially reported by a company representative on 15 October 2014 (initial receipt date previously reported as 17 October 2014). The information received 15 October 2014 identified the event as possible GBS. This information has been included in the case. Outcome remains unknown. Follow-up information received on 17 December 2014 from a healthcare professional. The patient did not present any illness at the time of the vaccination. Complementary examination of spinal fluid was performed: glucose in CSF was 58 and protein in CSF was 18 (units not provided). No culture was performed from spinal tap. MRI showed 3-4 white matter lesions in brain and small lesion in thoracic spinal cord which was enhancing. Neurologic exam was also performed. Numbness progressed to the dermatome. Patient was alert, oriented in time, place. Concentration was normal. Immediate recall and remote memory were normal. Fund of knowledge was good. Pupils were equal, round and normal reaction to light. Muscle of mastication: normal bulk. Face symmetrical and normal strength. Hearing normal bilaterally. Palate elevate symmetrically. Shoulder shrug was normal bilaterally. Tongue protrudes in the midline. No pronator drift or abnormal involuntary movements. Gross coordination normal. Gait normal. The patient was admitted to the hospital from 18 October 2014 until 21 October 2014. She was treated with IVIG and high dose SOLU-MEDROL. The final diagnosis was transverse myelitis. The patient returned to work on 01 December 2014. Follow-up information on this unsolicited case was received on 29 December 2014 from a healthcare professional. The patient on initial consult was found to have insidious onset of numbness that started in her toes. The numbness gradually progressed minimally every day up to the T6 dermatome level. An EMG nerve conduction study did not confirm or refute the GBS diagnosis. The IVIG was completed with no improvement. The patient started on five day SOLU-MEDROL which helped with symptoms and the numbness decreased to knee level. Final diagnosis was transverse myelitis. The patient was to follow-up with neurologist in one week. Outcome was not reported. Documents held by sender: hospital discharge summary.