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Life Threatening? No
Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hypotonic-hyporesponsive episode in a 2-month-old male patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included BEXSERO for prophylaxis, ROTARIX for prophylaxis and PREVENAR 13 for prophylaxis. Concomitant products included CALPOL. On 21st June 2018, the patient received the 1st dose of INFANRIX HEXA (intramuscular), the 1st dose of BEXSERO (intramuscular), the 1st dose of ROTARIX (unknown) and the 1st dose of PREVENAR 13 (intramuscular). On 21st June 2018, less than a day after receiving INFANRIX HEXA, BEXSERO and ROTARIX, the patient experienced hypotonic-hyporesponsive episode (serious criteria death) and sudden death unexplained (serious criteria death and GSK medically significant). On an unknown date, the patient experienced irritable (serious criteria death) and skin warm (serious criteria death). On an unknown date, the outcome of the hypotonic-hyporesponsive episode and sudden death unexplained were fatal and the outcome of the irritable and skin warm were unknown. The reported cause of death was sudden death unexplained and hypotonic-hyporesponsive episode. An autopsy was performed. It was unknown if the reporter considered the hypotonic-hyporesponsive episode, irritable, skin warm and sudden death unexplained to be related to INFANRIX HEXA, BEXSERO and ROTARIX. Additional information: The outcome of Hypotonic-hyporesponsive episode was reported as Not Recovered/Not Resolved. Initial information was received from a physician via regulatory authority on 8th January 2019: Hypotonic-hyporesponsive episode, irritable, skin warm and sudden death unexplained. Note: The date of death was reported as 23rd June 2018. However, the date for sudden death event was reported as 21st June 2018. Reported Cause(s) of Death: Sudden death; Hypotonic-hyporesponsive episode.
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