Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Death, Pyrexia, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: sudden infant death syndrome; found her not breathing; started having seizures; fever had a 102 degree; Initial information received on 13-Aug-2024 regarding an unsolicited valid serious Courtesy case received from a consumer/non-health care professional.   This case involves a 4 months old female patient who had sudden infant death syndrome, found her not breathing, started having seizures and fever had a 102 degree after receiving Prevnar 13 (Pneumococcal Vaccine Conj 13V (CRM197)), DTAP (Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid), HIB Vaccine and IPV (VERO) [IMOVAX POLIO].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (Suspension for injection) (lot number not reported) via unknown route in unknown administration site, unknown dose of suspect HIB Vaccine, DTAP and Prevnar 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for all Prophylactic vaccination (Immunization) (strength, expiry date was unknown for all the suspects). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.   On an unknown date the patient had sudden infant death syndrome (unknown latency), found her not breathing (respiratory arrest) , started having seizures (seizure) (latency : 3 days) and fever had a 102 degree (pyrexia) (unknown latency) following the administration of IPV (VERO), HIB Vaccine, DTAP and Prevnar 13.   Reportedly 4 month old baby got 6 shots on the 6th. She had a 102-degree fever and the doctor reassured mom it was okay. DTaP, Polio,Hib,and Prevnar13. 3 days later the babysitter found her not breathing and did CPR (Cardiopulmonary resuscitation). Once rushed to the ER(emergency room), she started having seizures.    Relevant laboratory test results included: Body temperature - On an unknown date: 102 deg   Final diagnosis was (fatal/life-threatening) sudden infant death syndrome. Action taken was not applicable for all the events.   A corrective treatment of CPR (Cardiopulmonary resuscitation) was received for the event (found her not breathing). At time of reporting, the outcome was Unknown for all the other events and Fatal for the event sudden infant death syndrome.     It is unknown if an autopsy was done. The cause of death was reported as sudden infant death syndrome.   Seriousness Criteria : Medically significant and Hospitalized for the events sudden infant death syndrome , seizures, respiratory arrest and leading to death, Life-threatening for the event sudden infant death syndrome.; Sender's Comments: Sanofi Company Comment dated 19-Aug-2024 : This case involves a 4-month-old female patient who had sudden infant death syndrome, found her not breathing, started having seizures and fever had a 102 degree after receiving Prevnar 13 (Pneumococcal Vaccine Conj 13V (CRM197)), DTAP (Diphtheria 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 events and Autopsy details are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.; Reported Cause(s) of Death: sudden infant death syndrome