Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Death, Pyrexia, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Sudden infant death syndrome; not breathing; seizures; 102 degree fever; The initial case was missing the following minimum criteria: identifiable reporter. Upon receipt of follow-up information on 17Sep2024, this case now contains all required information to be considered valid.  This is a spontaneous report and received from Consumer or other non HCPs, Program ID:. Other Case identifier(s): 2024SA244264 (Sanofi).  A 4-month-old female patient (not pregnant) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), as dose number unknown, single) for immunisation; polio vaccine inact 3v (vero) (IMOVAX POLIO), as dose number unknown, single) for immunisation; hib vaccine (HIB), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUDDEN INFANT DEATH SYNDROME (death, hospitalization, medically significant, life threatening), outcome "fatal"; RESPIRATORY ARREST (hospitalization, medically significant), outcome "unknown", described as "not breathing"; SEIZURE (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "unknown", described as "seizures"; PYREXIA (non-serious), outcome "unknown", described as "102 degree fever". The event "not breathing" required emergency room visit. The clinical course was reported as follows: The reporter indicated that the patient received 6 vaccines including diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP),  polio vaccine inact 3v (vero) (IMOVAX POLIO), hib vaccine (HIB), and pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13) on the 6th (as reported). The patient had a fever of 102 degree and the doctor reassured mom it was okay. Three days later, the babysitter found patient not breathing, and performed cardiopulmonary resuscitation (CPR). Once the patient was rushed to emergency room (ER), the patient started having seizures. The patient underwent the following laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of respiratory arrest. The patient date of death was unknown. Reported cause of death: "Sudden infant death syndrome". It was not reported if an autopsy was performed.  Sanofi comment: date 19Aug2024 this case involves a 4 month old female patient who had sudden infant death syndrome, found her not breathing, started having seizure and fever had a 102 degree after receiving Prevnar 13. (pneumococcal vaccine)  conj 13 V (CRM 197), DTAP (Diphteria vaccine toxoid, pertussis vaccine, Acellular, Tetanus vaccine toxoid), HIB Vaccine and IPV (vero) (Imovax Polio). Further information regarding past medical history, concurrent, condition, concomitant medication and tolerance, allergic history excluding alternative etiologies, for the reported event and autopsy details are needed to fully assess this case. Based upon the reported information,  the role of a vaccine cannot be assessed.   Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Sudden infant death syndrome