Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, UNK, UNK, UNK
Symptoms: Death, Intensive care, Resuscitation, Unresponsive to stimuli
Clinical narrative: Unresponsive to stimuli/was no longer responsive; Infant was pronounced deceased; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G) for prophylaxis.   Co-suspect products included HIB vaccine conj (OMPC) (PedvaxHIB) (batch number Y013470) for prophylaxis and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) (batch number LK6650) for prophylaxis.   The patient's past medical history included hyperglycemia, neuroleptic malignant syndrome, encephalitis (non infectious), encephalopathy, meningitis, hypotonic-hyporesponsive episode and hypoglycemia. Previously administered products included Beyfortus. Concurrent medical conditions included diabetes mellitus, guillain barre syndrome and intussusception. Additional patient notes included Patient had no any allergies.   On 13-MAR-2025, the patient received the 2nd dose of Pediarix (intramuscular), the 2nd dose of PedvaxHIB (intramuscular) and the 2nd dose of Prevnar 20 (intramuscular). On 13-MAR-2025 19:00, less than a day after receiving Pediarix, the patient experienced unresponsive to stimuli (Verbatim: Unresponsive to stimuli/was no longer responsive) (serious criteria hospitalization and GSK medically significant). On 14-MAR-2025 08:14, the patient experienced unknown cause of death (Verbatim: Infant was pronounced deceased) (serious criteria death, hospitalization and GSK medically significant). The outcome of the unresponsive to stimuli was not resolved. The patient died on 14-MAR-2025. The reported cause of death was unknown.   The reporter considered the unknown cause of death and unresponsive to stimuli to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     The company considered the unknown cause of death and unresponsive to stimuli to be unrelated to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. Patient took vaccine such as Pediarix ,Pedvax and Prevenar 20 in right and left leg respectively via intramuscularly. Consumer reported that infant was found at home unresponsive around 19:00 on 13th March 2025, father began Cardiopulmonary Resuscitation, and infant was brought to nearest hospital where the infant was then stabilized for transfer to a facility with an available pediatric provider. Infant slowly declined and was no longer responsive to treatments in ICU (intensive care unit). The reporter considered the unknown cause of death and unresponsive to stimuli to be related to PedvaxHIB  and Prevnar 20.; Sender's Comments: Death and Unresponsive to stimuli are unlisted events which are considered unrelated to GSK vaccine Pediarix and Pediarix Pre-Filled Syringe Device.; Reported Cause(s) of Death: Unknown cause of death