Age: 3.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Somnolence, Tonic convulsion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 3-year-old female patient who received HAVRIX pediatric (batch number J3K9H, expiry date 30th November 2018). On 17th March 2017 16:15, the patient received the 2nd dose of HAVRIX pediatric .5 ml. On 17th March 2017 21:15, 5 hrs after receiving HAVRIX pediatric, the patient experienced seizure (serious criteria GSK medically significant), abnormal breathing and skin discoloration. On 17th March 2017, the outcome of the seizure was recovered/resolved. On an unknown date, the outcome of the abnormal breathing and skin discoloration were unknown. It was unknown if the reporter considered the seizure, abnormal breathing and skin discoloration to be related to HAVRIX pediatric. Additional details were reported as follows: The patient was vaccinated with HAVRIX on right arm. As per the health care professional, the mother of the patient said that the patient had a seizure that lasted about 1 to 2 minutes, with breathing change and colour change. No other information was provided. Follow up information was received from nurse via call center representative on 19th April 2017: The reporter details were updated. The patient had no history of seizures including febrile seizures, epilepsy, movement disorders, head injury, other central nervous system conditions, cerebral palsy, neurological handicap or congenital abnormality, diabetes, renal failure, alcohol or drug abuse. The event was witnessed by mom and grandfather of the patient. On 17th March 2017, less than a day after vaccination, the patient was awake and started to complain of being scared then suddenly arched back, wrist and elbows flex, fingers fisted for 30 to 60 seconds with postictal sleep for 5 to 10 minutes. Less than a day after vaccination, the patient was screaming out and had a tonic seizures with no dysfunction when the patient was awake. The duration of the seizure was 1 to 2 minutes. The patient was screaming with a complaint of being scared. The patient had no fever or ill symptoms. There were no automatisms. The patient was sleepy post spell for 10 to 20 minutes. On 24th March 2017, electroencephalogram (EEG) was unremarkable brain MRI. On 28th March 2017, the patient was witnessed by mom and grandfather of the patient again. Eleven days after vaccination, the patient was awake and started crying for no obvious reason and then fell sleep. In sleep the patient gritted her teeth, twitched and then 2 episodes of tensing up like previous seizures elbows and fingers flexed for seconds to minutes duration and slept a while after. On 28th March 2017, head computerized tomography (CT) with or without was unremarkable. On 13th April 2017, at 8:00 AM, the patient's magnetic resonance imaging brain without and with IV contrast was performed. The technique was multi sequence, multiplanar seizure protocol magnetic resonance imaging of the brain with and without IV contrast. Sequences obtained include sagittal T1, axial T2, axial T1, axial T2 GRE, axial FLAIR, and diffusion weighted scans. Gadolinium based IV contrast was administered and post contrast sequences were obtained. Post processed ADC maps were generated from the DWI data. Comparison was none. It revealed no intra-axial or extra-axial masses, fluid collections, or midline shift. The ventricles and sulci are normal in size. No intracranial hemorrhage. Gray-white differentiation was preserved. The sella and its contents are unremarkable. No abnormal restricted diffusion to suggest recent infarction. The mesial temporal lobes are symmetric and unremarkable. The corpus callosum is intact. Cortical gyration and sulcation was unremarkable. No pathologic post-contrast enhancement intracranially. Expected major intracranial arterial flow voids at the skull base are present. The orbits are symmetric and unremarkable. The mastoid air cells are clear. The visualized paranasal sinuses are clear. The impression was unremarkable brain magnetic resonance imaging. The VAERS details were updated.