Report #2895671

Overview

Sex

Female

Age

Age unknown

State

HI

Recovered

Recovered

Vaccinated

Apr 29, 2026

Onset

Apr 30, 2026

Days to onset

1

Hospital days

—

Symptoms (14)

Symptom narrative

Mother reported patient staring ""up"" and would not respond to mother. No cyanosis. No stiffening or twitching; Fever of 101.6; Blood glucose; C-Reactive protein; CSF Test; Electroencephalogram; Full blood count; Influenza Virus Test; Metabolic Function test; Procalcitonin; Respiratory Syncytial Virus test; SARS-COV-2 Test; Urine Analysis; This serious case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 07-JUL-2026 with the following reference number 2895671-1. The original narrative from the sender is as below: "Received vaccine on 4/29/26 at 1549. Possible seizure activity on 4/30/26 @0900. Mother reported patient staring "up" and would not respond to mother. Episode lasted 1 minute. No cyanosis. No stiffening or twitching. No history of fever. Patient was taken to emergency room 4/30/26 at 1026am noted to have fever of 101.6." No medical history was reported. No concomitant medication was reported. Laboratory tests performed included: CBC, CRP, CMP, Procalcitonin, urinalysis, CSF studies, glucose, COVID/Flu/ RSV and EEG. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events 'mother reported patient staring "up" and would not respond to mother. No cyanosis. No stiffening or twitching' and fever of 101.6. Due to the nature of the events, the causality of the events Blood glucose, C-reactive protein, CSF test, Electroencephalogram, Full blood count, Influenza virus test, Metabolic function test, Procalcitonin, Respiratory syncytial virus test, Sars-cov-2 test, Urine analysis and Vaxelis was not applicable. No further information is expected; Sender's Comments: Unresponsive to stimuli was assessed as serious due to being medically significant (IME list). Pyrexia, Blood glucose, C-reactive protein, CSF test, Electroencephalogram, Full blood count, Influenza virus test, Metabolic function test, Procalcitonin, Respiratory syncytial virus test, Sars-cov-2 test, Urine analysis were assessed as non-serious. Pyrexia is listed, whereas Unresponsive to stimuli, Blood glucose, C-reactive protein, CSF test, Electroencephalogram, Full blood count, Influenza virus test, Metabolic function test, Procalcitonin, Respiratory syncytial virus test, Sars-cov-2 test, Urine analysis are unlisted for Vaxelis as per the Reference Safety Information (CCDS). Considering the plausible temporal sequence (events occurred shortly after vaccination), the current knowledge of the vaccine (Pyrexia is listed as per CCDS), and despite the co-suspect vaccines as confounding factors and the lack of information in this case (medical history of prior similar events), the causal relationship between Vaxelis and the events of Unresponsive to stimuli and Pyrexia cannot be excluded and is assessed as related. Due to the nature of the events, the causality of the events Blood glucose, C-reactive protein, CSF test, Electroencephalogram, Full blood count, Influenza virus test, Metabolic function test, Procalcitonin, Respiratory syncytial virus test, Sars-cov-2 test, Urine analysis and Vaxelis is not applicable. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

Current illness

Prophylaxis

Lab data

Test Date: 20260430; Test Name: Fever; Result Unstructured Data: Test Result:101.6 N/A;N/A