Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | — | — |
seizures; This spontaneous serious safety report with reference number 02742982 (Interaction number 02742981) was received by a partner on 27-JAN-2025 and forwarded on 28-JAN-2025 from a health care professional. A 6-month-old male patient had been vaccinated with unknown dose of Vaxelis (batch number not provided), on an unknown date for prophylaxis. No medical history was provided. No concomitant vaccinations were reported. On an unknown date, the patient experienced seizures after recently having been administered a dose of Vaxelis. The provider reported that the infant was hospitalized, and it was determined that he had a virus. She also stated that the infant recovered and went on to receive additional immunizations. The event was recovered/resolved. Action taken with Vaxelis was unknown. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "seizures". It was reported that the patient had a virus (alternative causality). Further information is expected. COMPANY COMMENT: Seizure is assessed as serious due to causing hospitalization. Seizure is listed for Vaxelis as per the Reference Safety Information. Considering the current knowledge on Vaxelis (Seizure is listed as per regulatory authority) and that the events appeared after the recent vaccination with Vaxelis, and despite the lack of information (relevant medical history not provided) and no confounding factors (co-suspect vaccines), and the alternate causality (virus positive) provided, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related. 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 is assessed as serious due to causing hospitalization. Seizure is listed for Vaxelis as per the Reference Safety Information. Considering the current knowledge on Vaxelis (Seizure is listed as per regulatory authority) and that the events appeared after the recent vaccination with Vaxelis, and despite the lack of information (relevant medical history not provided) and no confounding factors (co-suspect vaccines), and the alternate causality (virus positive) provided, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related. 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.
Prophylaxis