Sex: M
Vaccine: PNC13, DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Crying, Laboratory test, Magnetic resonance imaging, Seizure
Clinical narrative: Seizure episodes began on 03/11 taken to ER transferred to medical center where multiple episodes were recorded; Mom states that day of vaccines given 03/07 patient started getting fussy and this was unusual; Blood culture; Computerised Tomogram head normal; Culture urine; Electroencephalogram abnormal; Metabolic function test; Urine analysis; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2621576-1. The original narrative from the sender is the following:  Patient mom states that day of vaccines given 03/07, patient started getting fussy and this was unusual for the patient. Seizure episodes began on 03/11, was taken to ER where he was then transferred to Medical Center where multiple episodes were recorded, pt was put on Keppra.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the events "Infant irritability and Seizure".  No further information is expected.  COMPANY COMMENT: Infant irritability and Seizure were assessed as serious due to hospitalization, whereas the events Blood culture, Computerised tomogram Head normal, Culture urine, Electroencephalogram abnormal, Metabolic function test, Urine analysis were assessed as non-serious.  Blood culture, Computerised tomogram Head normal, Culture urine, Electroencephalogram abnormal, Metabolic function test and Urine analysis are unlisted, while Seizure and Infant irritability is listed as per the Reference Safety Information.   Considering the current knowledge on the vaccine (Seizure is listed) and the short onset latency (within 2 days of vaccination), and despite the confounding factor (co-suspect vaccine) and the lack of information in this case (no medical history), the causal relationship between Vaxelis and Infant irritability and Seizure cannot be excluded and is assessed as related.  Due to the nature of the events, the causal relationship between Vaxelis and Blood culture, Computerised tomogram Head normal, Culture urine, Electroencephalogram abnormal, Metabolic function test and Urine analysis were 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: Infant irritability and Seizure were assessed as serious due to hospitalization, whereas the events Blood culture, Computerised tomogram Head normal, Culture urine, Electroencephalogram abnormal, Metabolic function test, Urine analysis were assessed as non-serious.  Blood culture, Computerised tomogram Head normal, Culture urine, Electroencephalogram abnormal, Metabolic function test and Urine analysis are unlisted, while Seizure and Infant irritability is listed as per the Reference Safety Information.   Considering the current knowledge on the vaccine (Seizure is listed) and the short onset latency (within 2 days of vaccination), and despite the confounding factor (co-suspect vaccine) and the lack of information in this case (no medical history), the causal relationship between Vaxelis and Infant irritability and Seizure cannot be excluded and is assessed as related.  Due to the nature of the events, the causal relationship between Vaxelis and Blood culture, Computerised tomogram Head normal, Culture urine, Electroencephalogram abnormal, Metabolic function test and Urine analysis were 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.