Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Electroencephalogram, Magnetic resonance imaging, Pyrexia, Seizure
Clinical narrative: Seizure 2-3 minutes on night of vaccine 12/21 suspected due to fever. Followed by second seizure unprovoked in 12/28.; Fever; Electroencephalogram; Magnetic resonance imaging; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2728926-1. The original narrative from the sender is the following:   Seizure 2-3 minutes on night of vaccine 12/21 suspected due to fever. Followed by second seizure unprovoked in 12/28.  Concomitant medication included Omeprazole 2.5 milligram (mg) twice a day (bid).  Relevant medical history included suspected Cow milk protein allergy and adverse event after prior vaccination caused fever on 22-OCT-2023.  Laboratory investigations included (electroencephalogram (EEG), magnetic resonance imaging (MRI) and (emergency room) ER admit.    No further information is expected.   COMPANY COMMENT: Seizure and Pyrexia are assessed as serious due to being life-threatening. Electroencephalogram and Magnetic resonance imaging are assessed as non-serious.   Seizure and Pyrexia are listed, whereas Electroencephalogram and Magnetic resonance imaging are unlisted for Vaxelis as per the Reference Safety Information (CCDS).    Considering the current knowledge on the vaccine (Seizure and Pyrexia are listed) and that the events occurred immediately after vaccination (within 1 day), the medical history (prior adverse event following vaccination and cow's milk allergy) and the co-suspect vaccines as a confounding factor, the causal relationship between Vaxelis and the events of Seizure and Pyrexia cannot be excluded and is assessed as related. Due to the nature of the events, the causal relationship between Vaxelis and the events of Electroencephalogram and Magnetic resonance imaging is assessed as 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.; Sender's Comments: Seizure and Pyrexia are assessed as serious due to being life-threatening. Electroencephalogram and Magnetic resonance imaging are assessed as non-serious.   Seizure and Pyrexia are listed, whereas Electroencephalogram and Magnetic resonance imaging are unlisted for Vaxelis as per the Reference Safety Information (CCDS).    Considering the current knowledge on the vaccine (Seizure and Pyrexia are listed) and that the events occurred immediately after vaccination (within 1 day), the medical history (prior adverse event following vaccination and cow's milk allergy) and the co-suspect vaccines as a confounding factor, the causal relationship between Vaxelis and the events of Seizure and Pyrexia cannot be excluded and is assessed as related. Due to the nature of the events, the causal relationship between Vaxelis and the events of Electroencephalogram and Magnetic resonance imaging is assessed as 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.