Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Death
Clinical narrative: Nurse wanted to report that one of their patients who recently had VAXELIS died.; This serious spontaneous Safety Report, with GPV Case number 2024SA376022 (Inquiry # 02348679) was received by partner on 19-DEC-2024 and forwarded on 20-DEC-2024 from a healthcare professional. Additional information was received on 20-DEC-2024 from the healthcare professional.  A 4-month-old male patient of an unknown ethnicity with an unknown medical history had been vaccinated with Vaxelis (unknown dose number) on 06-Dec-2024 for immunization (Batch# U7907AA; expiration date 30-SEP-2026 (also reported as 20-SEP-2026).  No concomitant vaccinations were reported.  On an unspecified date, nurse wanted to report that one of their patients who recently had VAXELIS died.  The patient was vaccinated on 06-DEC-2024 and was supposed to follow up at the health care facility for additional vaccines on 20-DEC-2024. When contacted by phone for reminder of scheduled appointment, the house member informed that patient passed away and funeral was set for 19-DEC-2024.  The approximate date of death was reported as sometime after 06-DEC-2024 to 19-DEC-2024. It was unknown if an autopsy was performed.  The outcome of the event was fatal.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the event of death.  Further information is not expected, as the reporter provided all the information available.  COMPANY COMMENT Death was assessed as serious due to being fatal.  Death is unlisted for Vaxelis, as per the Reference Safety Information.  There is limited information regarding the circumstances that lead to the event (no medical history, cause of death, event details, or co-suspect vaccinations reported). Given the current knowledge of the vaccine (Death is unlisted) and due to the limited clinical details precluding comprehensive assessment, the causal relationship between Vaxelis and Death is assessed as not 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: Death was assessed as serious due to being fatal.  Death is unlisted for Vaxelis, as per the Reference Safety Information.  There is limited information regarding the circumstances that lead to the event (no medical history, cause of death, event details, or co-suspect vaccinations reported). Given the current knowledge of the vaccine (Death is unlisted) and due to the limited clinical details precluding comprehensive assessment, the causal relationship between Vaxelis and Death is assessed as not 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.; Reported Cause(s) of Death: Nurse wanted to report that one of their patients who recently had VAXELIS died.