Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Acute disseminated encephalomyelitis, Bladder catheterisation, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of acute disseminated encephalomyelitis in a 8-year-old male patient who received HAVRIX pediatric (batch number 4B299, expiry date 17th December 2016) and (batch number 4B299, expiry date unknown). Concomitant products included amoxicillin, azithromycin and ceftriaxone. On 23rd September 2014, the patient received HAVRIX pediatric. On an unknown date, the dose was an unknown dose. On 24th October 2014, 31 days after receiving HAVRIX pediatric, the patient experienced headache and fever. On 3rd November 2014, the patient experienced acute disseminated encephalomyelitis (serious criteria hospitalization, disability, GSK medically significant and clinically significant/intervention required), leg pain (serious criteria hospitalization and disability), numbness (serious criteria hospitalization, disability and clinically significant/intervention required), urinary retention (serious criteria hospitalization, disability, GSK medically significant and clinically significant/intervention required), muscle disorder (serious criteria hospitalization, disability and clinically significant/intervention required), bladder incontinence (serious criteria hospitalization, disability and clinically significant/intervention required) and tingling (serious criteria hospitalization, disability and clinically significant/intervention required). On an unknown date, the outcome of the acute disseminated encephalomyelitis, leg pain, numbness, muscle disorder, fever and tingling were recovering/resolving and the outcome of the headache was recovered/resolved and the outcome of the urinary retention and bladder incontinence were unknown. The reporter considered the acute disseminated encephalomyelitis, headache, leg pain, numbness, urinary retention, muscle disorder, fever, bladder incontinence and tingling to be possibly related to HAVRIX pediatric. Additional details provided: Pharmacist reports a patient who started experiencing a fever and headache about 1 month after receiving a HAVRIX vaccine. He went to the ER and it was thought that he had sinusitis and was given oral antibiotics. The headache and fever continued and he was admitted to the hospital on 11/3/2014 with leg pain, numbness and tingling and bladder incontinence. The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) and started on steroid therapy. The patient was still complaining of poor muscle control and tingling. He has a Foley in place so the pharmacist was unable to evaluate how the bladder was progressing. She considered some of these symptoms to be disabling because he was not able to move around and be mobile because of the poor muscle control, tingling and poor bladder control. She considered the patient jeopardized because there were concerns that the tingling and poor muscle control, as well as the MRI abnormalities meant he might no longer be able to walk, so he was started on steroid therapy as an intervention.