Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Sudden infant death syndrome
Clinical narrative: sudden infant death syndrome; found her not breathing; started having seizures; Fever having 102 degree; This serious case was reported by a consumer via other manufacturer and described the occurrence of sudden infant death syndrome in a 4-month-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included Hib UNK (Hib vaccine) for prophylaxis, Polio vaccine inact 3v (Vero) (Imovax polio) for prophylaxis and Pneumococcal vaccine conj 13v (CRM197) (Prevenar 13) for prophylaxis.   On an unknown date, the patient received DTaP vaccine, Hib vaccine, Imovax polio and Prevenar 13. On an unknown date, an unknown time after receiving DTaP vaccine and Hib vaccine, the patient experienced sudden infant death syndrome (Verbatim: sudden infant death syndrome) (serious criteria death, hospitalization, GSK medically significant, life threatening and other: serious as per reporter), respiratory arrest (Verbatim: found her not breathing) (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), seizure (Verbatim: started having seizures) (serious criteria hospitalization, GSK medically significant and other: serious as per reporter) and fever (Verbatim: Fever having 102 degree) (serious criteria hospitalization and other: serious as per reporter). The outcome of the respiratory arrest, seizure and fever were unknown. The reported cause of death was sudden infant death syndrome.   The reporter considered the sudden infant death syndrome, respiratory arrest, seizure and fever to be related to DTaP vaccine and Hib vaccine.     The company considered the sudden infant death syndrome and respiratory arrest to be unrelated to DTaP vaccine and Hib vaccine. The company considered the seizure and fever to be related to DTaP vaccine. The company considered the seizure to be related to Hib vaccine. The company considered the fever to be unrelated to Hib vaccine.   Additional Information: GSK Receipt Date: 24-SEP-2024 The patient had sudden infant death syndrome, found her not breathing, started having seizures and fever had a 102 degree after receiving Prevenar 13, DTAP, HIB vaccine and IPV (Imovax polio) vaccine. The patient's past medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received a unknown dose of suspect IPV (lot number not reported) via unknown route in unknown administration site for all the 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 102 degree (pyrexia) (unknown latency) following the administration of IPV, HIB Vaccine, DTAP and Prevenar 13. The patient had got 6 shots on the 6th and 3 days later the babysitter found her not breathing and did CPR (Cardiopulmonary resuscitation) and once rushed to the ER (emergency room), she started having seizures. It was unknown if an autopsy was done. The reporter considered the sudden infant death syndrome, respiratory arrest, seizure and fever to be related to Imovax polio and Prevenar 13.; Sender's Comments: Sudden infant death syndrome, Respiratory arrest are unlisted events which are considered unrelated to GSK vaccine DTaP vaccine. Seizure and Pyrexia are listed events which are considered related to GSK vaccine DTaP vaccine. Sudden infant death syndrome, Respiratory arrest and Pyrexia are unlisted events which are considered unrelated to GSK vaccine Hib vaccine. Seizure is an unlisted event which, due to the following criteria (strong temporal association) is considered related to GSK vaccine Hib vaccine.; Reported Cause(s) of Death: sudden infant death syndrome