Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Death
Clinical narrative: They received a dose of Vaxelis, Beyfortus, Pneumo and Rota. The child passed away two days after the clinic visit.; This spontaneous Safety Report, with Case number 2024SA076654, was received by partner on 06-Mar-2024 and forwarded to RA on 07-Mar-2024 from a HCP.  This case was considered non-valid due to no patient identifiers.  A patient of unknown age with an unknown medical history had been vaccinated with Vaxelis on an unknown date for prophylaxis.  No concomitant vaccinations were reported.  On an unknown date a child had visited a clinic for a two month immunization. The child received a dose of Vaxelis, Beyfortus (nirsevimab), Pneumo (pneumococcal vaccine), and Rota (rotavirus vaccine). On an unspecified date, the child passed away two days, after the clinic visit. It is unknown if an autopsy was performed.  The action taken with Vaxelis was not applicable due to death of the patient.  At time of this report, the outcome of the event was fatal.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the event.  FOLLOW-UP INFORMATION was received by RA on 12-MAR-2024 from a health care professional. This case is now considered valid due to patient identifiers being provided.  A 2-month-old female patient, with a medical history of 35-week premature baby, fetal exposure to drugs (maternal positive for Tetrahydrocannabinol (THC) at delivery), meconium at delivery, neonatal jaundice and baby did not pass car seat test first time prior to discharge from hospital, had been vaccinated with Vaxelis on an unknown date for prophylaxis. Additional medical history provided was that mom was sick with Flu type B at the time of delivery.  The following concomitant medications were reported: RotaTeq vaccine (rotavirus), Prevnar 20 (pneumococcal vaccine conjugate 20V), Beyfortis (nirsevimab) for prophylaxis and Cholecalciferol (vitamin D) for unknown indication.  On 01-FEB-2024, 2 days after vaccination, the patient's death was reported. At the time of this report, it was unknown whether an autopsy was performed. Social work and Regulatory Authority was reported to be involved in investigating further the occurrence of the event.  At time of this report, the outcome of the event was fatal (death).  The reporter assessed the event to have no reasonable possibility of a causal relationship to Vaxelis, however no alternate etiology was provided.  Company Comment: Death was assessed as serious due to being fatal.  Death is unlisted for Vaxelis as per the Reference Safety Information (CCDS, RA).  Considering the medical history reported (mom sick at delivery, fetal exposure to drugs (THC), baby did not pass car seat test at hospital discharge), and despite the co-suspect vaccines (Beyfortus, Prevnar 20 and RotaTeq), the causal relationship between Vaxelis and the Death event is assessed as not related, in agreement with the reporter's causality.  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 (CCDS, RA).  Considering the medical history reported (mom sick at delivery, fetal exposure to drugs (THC), baby did not pass car seat test at hospital discharge), and despite the co-suspect vaccines (Beyfortus, Prevnar 20 and RotaTeq), the causal relationship between Vaxelis and the Death event is assessed as not related, in agreement with the reporter's causality.  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: They received a dose of Vaxelis, Beyfortus, Pneumo and Rota. The child passed away two days after the clinic visit.