VAERS ID: 1799910

Description

Cerebrospinal fluid cell count increased/it was 104/uL; Cerebrospinal fluid protein increased/it was 57 mg/dL; IgG index increase, 0.75(less than 0.73); Muscle weakness lower limb (left limb); diffuse or multiple white matter lesions/diffuse, ill-defined, and large (more than 1-2 cm) lesion predominantly in the cerebral white matter; deep gray matter lesion; head MRI was conduct, abnormalities were found in Cerebrum, brain stem and thalamus.; difficulty in walking; pyrexia/low grade fever; Light-headed feeling; fuzzy head; Acute disseminated encephalomyelitis; This is a spontaneous report from a contactable physician received via COVID-19 regulatory authority and from Regulatory Agency (RA). Regulatory authority report number is v21128594. The patient was a 12-year and 2-month-old male (age at vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient's concomitant medications were not reported. On 27Jul2021, the patient previously received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via intramuscular route of administration in the left arm for COVID-19 immunization. On 17Aug2021 (the day of vaccination), the patient received the second single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3622, Expiration date 30Nov2021) via intramuscular route of administration in the left arm for COVID-19 immunization. On 09Sep2021 (23 day after the vaccination), the patient experienced Acute disseminated encephalomyelitis. Appeared in 09Sep2021. The event resulted in hospitalization. Duration of Hospitalization was 17 days. On 06Sep2021 (20 days after the vaccination), the patient experienced the following events. Clinical course of the events was reported as follows: On 09Sep2021 (23 days after the vaccination), pyrexia, light-headed feeling and fuzzy head often appeared. On 11Sep2021 (25 days after the vaccination), difficulty in walking. On 14Sep2021 (28 days after the vaccination), head MRI was conducted, abnormalities were found scattering in Cerebrum, brain stem and thalamus. On 15Sep2021 (29 days after the vaccination), the patient was transferred to other hospital, low grade fever, Light-headed feeling and Muscle weakness lower limb (left limb) appeared. Cerebrospinal fluid cell count increased and it was 104/uL. Protein increased and it was 57 mg/dL. On 09Sep2021 (23 days after the vaccination), the patient was admitted to the hospital. On 29Sep2021 (43 days after the vaccination), the patient was discharged from the hospital. Questionnaire for acute disseminated encephalomyelitis (ADEM) case was received as follows: no histopathological diagnosis was conducted. Clinical symptoms reported as follows: possibly associated with inflammatory demyelination. This was the first episode in the patient (irrespective of preceding vaccination). Clinically multifocal central nervous disorder (event). Date of the initial onset of any of the symptoms below was 09Sep2021 (23 day after the vaccination): encephalopathy (e.g., decreased or altered consciousness level, lethargy, or personality change persisting for at least 24 hours), motor paralysis (diffuse, or more frequently localized), sensory aberrations (regardless of sensory levels) and cerebellar dysfunction (e.g., ataxia, dysmetria, cerebellar nystagmus). Imaging examination (Magnetic resonance imaging (MRI) was conducted on 14Sep2021 (28 days after the vaccination), the details as follows: diffuse or multiple white matter lesions observed on T2-weighted images, diffusion-weighted images (DWI), or fluid attenuated inversion recovery (FLAIR) images (with or without enhancement with gadolinium on T1-weighted images). Findings as follows: diffuse, ill-defined, and large (more than 1-2 cm) lesion predominantly in the cerebral white matter, no white matter lesion of low signal intensity on T1-weighted images and deep gray matter lesion (e.g., that observed in the thalamus or the basal ganglion). NOT applicable to at least one of the following MRI criteria for multiple sclerosis: 1. Demonstration of dissemination in space on MRI. At least one lesion observed on T2-weighted images in at least 2 areas among 4 areas of the central nervous system (around the cerebral ventricle, right below the cortex, below the tentorium, and in the spinal cord) (not necessarily to be enhanced lesions, and lesions responsible to these symptoms should be excluded in patients with brain stem or spinal symptoms) and 2. Dissemination in time on MRI. Asymptomatic gadolinium-enhanced lesions and asymptomatic non-enhanced lesions existing simultaneously at any time, or symptomatic or asymptomatic lesions on T2-weighted images and/or gadolinium-enhanced lesions, newly emerging after MRI at any reference point of time. Course of disease reported as follows: Observation period of less than 3 months after onset. Cerebrospinal fluid test was conducted on 15Sep2021 (29 days after the vaccination), the details as follows: cell count was 104/uL, glucose was 57 mg/dL, protein was 57 mg/dL, there was no oligoclonal bands, and there was IgG index increased, 0.75 (less than 0.73) (as reported). Autoantibody test reported as follows: Anti-AQP4 antibody test and Anti-MOG antibody test were conducted on 15Sep2021 (29 days after the vaccination), and the result were negative. The outcome of the event acute disseminated encephalomyelitis was recovering with treatment including Steroidal pulse therapy. On 29Sep2021 (43 days after the vaccination), the outcome of the events was recovering. Since the vaccination, the patient has been tested for COVID-19, and the test was conducted on 07Sep2021 (21 days after the vaccination) by nasopharyngeal swab. The result was negative. The reporting physician classified the events serious (hospitalization) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: At the time of discharging from the hospital, the patient received a treatment with Steroidal pulse therapy. It was scheduled to be followed-up in outpatient. No follow-up attempts are possible. No further information is expected.

Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)