Age: 15.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Immunoglobulin therapy, Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Metabolic function test normal
Clinical narrative: Subsequently diagnosed with transverse myelitis; This literature case was received on 01-May-2023 and concerned a 15-year-old, male patient.  This case report presented the patient with new onset urinary incontinence who initially presented to the urologist and was subsequently diagnosed with transverse myelitis.  The patient's concurrent condition included upper respiratory infection symptoms. The patient's concomitant medications were not reported. The patient's historical condition included anxiety. The patient had no prior surgical or urologic history.  On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; route of administration, anatomical location, dose, and indication: not reported). The batch number was not reported.  On the same date, the patient was also vaccinated with non-company, co-suspect HPV vaccine (brand not specified; route of administration, anatomical location, dose, and indication: not reported). The batch number was not reported.  On an unspecified date, about two weeks after receiving the influenza vaccine and non-company, co-suspect HPV vaccine, the patient presented to the pediatric urologist with new onset urinary incontinence for ten days. The incontinence was so severe and unpredictable that the patient required the use of diapers. The patient complained of urinary frequency, urge incontinence, and feelings of incomplete emptying. The patient denied fecal incontinence. Additional review of systems (ROS) included numbness and 'pins and needles' involving both feet for four weeks. Physical exam revealed a Tanner 4 male with decreased sensation from mid-calf to foot bilaterally in a patchy distribution. A renal/bladder US showed no hydronephrosis bilaterally and a post void residual of 58 mL. A urinalysis, complete blood count (CBC), basic metabolic panel (BMP), c-reactive protein (CRP), and thyroid-stimulating hormone (TSH) were all normal but a serum Lyme assay was elevated. Magnetic resonance imaging (MRI) contrast/non-contrast of the spine showed 'abnormal signal intensity within the cord from T5 to T11 with diffusion restriction as well as patchy enhancement' concerning for transverse myelitis. The cervical and lumbar portions of the spine were normal. MRI brain was negative. A Lumbar puncture was performed without any significant cerebrospinal fluid (CSF) findings. The patient was started on high dose methylprednisolone and intravenous immunoglobulin (IVIG) in the in-patient setting. The patient was discharged three days later on a prednisone taper and doxycycline. At the time of discharge, the patient reported improvement in lower extremity sensation but continued to have urinary incontinence. The patient followed up in the office several weeks later and was noted to have a near-complete resolution of his urologic.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The event was considered to be serious due to seriousness criterion of hospitalization. Additionally, the event was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.   Company comment: A 15-year-old patient experienced urinary incontinence about two weeks after receiving the suspect product influenza vaccine and non-company, co-suspect HPV vaccine. The patient complained of urinary frequency, urge incontinence, and feelings of incomplete emptying. Additional review of systems included paraesthesia and hypoesthesia of both feet for four weeks. Physical exam revealed a Tanner 4 male with decreased sensation from mid-calf to foot bilaterally in a patchy distribution. Serum Lyme assay was elevated. Magnetic resonance imaging (MRI) contrast/non-contrast of the spine showed 'abnormal signal intensity within the cord from T5 to T11 with diffusion restriction as well as patchy enhancement' concerning for transverse myelitis. The patient was started on high dose methylprednisolone and intravenous immunoglobulin. Based on available information causality between the suspect vaccine and the event of transverse myelitis is assessed as possibly related. Per Agency criteria, presented information correspond to level 1 diagnostic certainty for myelitis.; Sender's Comments: A 15-year-old patient experienced urinary incontinence about two weeks after receiving the suspect product influenza vaccine and non-company, co-suspect HPV vaccine. The patient complained of urinary frequency, urge incontinence, and feelings of incomplete emptying. Additional review of systems included paraesthesia and hypoesthesia of both feet for four weeks. Physical exam revealed a Tanner 4 male with decreased sensation from mid-calf to foot bilaterally in a patchy distribution. Serum Lyme assay was elevated. Magnetic resonance imaging (MRI) contrast/non-contrast of the spine showed 'abnormal signal intensity within the cord from T5 to T11 with diffusion restriction as well as patchy enhancement' concerning for transverse myelitis. The patient was started on high dose methylprednisolone and intravenous immunoglobulin. Based on available information causality between the suspect vaccine and the event of transverse myelitis is assessed as possibly related. Per Agency criteria, presented information correspond to level 1 diagnostic certainty for myelitis.