Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Gait disturbance, Headache, Hyperventilation, Hypoaesthesia
Clinical narrative: fever of 103.5; Autoimmune; bowel incontinence; deep breathing; tingling in the tip of his tongue; pneumonia; Strep URI; face and mouth being numb; disc herniation; difficulty walking; myelitis; cough; trouble breathing; headache; dizziness; Initial information received on 10-Aug-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 34 years old male patient (180 cm and 190 kg) who experienced myelitis, autoimmune, fever of 103.5, bowel incontinence, cough, deep breathing, dizziness, headache, tingling in the tip of his tongue, pneumonia, strep uri, face and mouth being numb, disc herniation, trouble breathing and difficulty walking after receiving influenza quadrival A-B intradermal vaccine[Fluzone].  The patient's past medical history included Weakness, Low back pain, Sexual dysfunction, Bladder incontinence, Anxiety and Spasticity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Chronic fatigue, Depression and Sensory deficit.   On 21-Oct-2016, the patient received 0.1 (unspecified units) of suspect influenza quadrival A-B intradermal vaccine lot UT5570BA via intradermal route in the right arm for prophylactic vaccination (strength and expiry date: unknown).  On 15-Nov-2016 the patient had myelitis, autoimmune (autoimmune disorder), bowel incontinence (anal incontinence), cough, deep breathing (hyperventilation), dizziness, headache, tingling in the tip of his tongue (paraesthesia oral), pneumonia, strep uri (upper respiratory tract infection), face and mouth being numb (hypoaesthesia), disc herniation (intervertebral disc protrusion), trouble breathing (dyspnoea), difficulty walking (gait disturbance) (latency 25 days).  On 03-Dec-2016 the patient had fever of 103.5 (pyrexia) (latency 1 month 13 days).   Relevant laboratory test results included: Blood test - On an unknown date:  [bloodwork came back negative for viral/bacterial infection] Body temperature - On 03-Dec-2016:  [fever of 103.5] Magnetic resonance imaging - On 03-Dec-2016: ; on 31-Mar-2017:  [TII-12 minimal disc space is seen with minimal annular type disc bulge producing minimal thecal sac impingement] Streptococcus test - On an unknown date: Positive  Reportedly, At L5-S 1 prior left laminectomy was identified with enhancing scar abutting the disc space and left lateral canal and left S 1 nerve root. Considering the enhancement, no specific recunent disc herniation was identified. Some residual disc bulge or broad-based disc herniation was seen within the right lateral canal producing minimal thecal sac impingement. Moderate bilateral mild bilateral neuroforaminal was seen. No malignant bone marrow replacement or cord signal abnormality was seen. A 3 mm focus of contrast enhancement in the right superior cerebellar peduncle was noted on TI postcontrast axial image 8 after further review. This punctate focus of signal intensity seen on a single axial slice was of uncertain etiology or clinical significance. Attention on follow-up imaging was recommended to exclude a true underlying lesion such as a demyelinating plaque or neoplasm. The 3.5 em long low TII high T2-weighted intra-axial lesion within the proximal cervical cord at the C2 and C3 vertebral body levels demonstrates patchy enhancement after contrast administration. This lesion had not enlarged since the recent comparison study, and no other enhancing cord lesions were seen in the lower cervical or upper thoracic cord. No hemorrhage was evident. No enhancing paraspinal soft tissue mass was present. Punctate soft tissue cysts about the nasopharynx do not enhance and are incidental. Vertebral bodies were normal in height. signal, and alignment. No enhancing marrow lesion was present. Discs appear normal without significant herniation. There was no spinal canal stenosis or cord compression  Action taken: not applicable.  The patient was treated with penicillin v benzathine (penicillin v benzathine) for Hypoaesthesia and unknown for other events.  Outcome was Not Recovered / Not Resolved for all the events.  Seriousness criteria: Medically significant for myelitis, autoimmune disorder and pneumonia, Disability for all events.; Sender's Comments: Sanofi Company Comment dated 14-Aug-2023: This case involves a 34 years old male patient (180 cm and 190 kg) who experienced myelitis, autoimmune, fever of 103.5, bowel incontinence, cough, deep breathing, dizziness, headache, tingling in the tip of his tongue, pneumonia, strep uri, face and mouth being numb, disc herniation, trouble breathing and difficulty walking after receiving influenza quadrival A-B intradermal vaccine[Fluzone]. Additionally patient's medical history of Weakness, Low back pain, Sexual dysfunction, Bladder incontinence, Anxiety and Spasticity, and ongoing Depression and Sensory deficit condition could be confounding factor for events to occur.Further information regarding previous vaccination, concomitant medication and tolerance, allergic history, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.