Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Resuscitation
Clinical narrative: This case was reported by a consumer and described the occurrence of death in a 6-week-old male patient who received PEDIARIX (batch number S232P5, expiry date 30th August 2016). Co-suspect products included PEDIARIX (batch number S232P5, expiry date 30th August 2016), PEDIARIX (batch number S232P5, expiry date 30th August 2016), PEDIARIX (batch number S232P5, expiry date 30th August 2016), ROTARIX (batch number A41CB452A, expiry date 31st January 2016) and Hib (batch number SUI062AEA, expiry date 10th October 2015). On 27th October 2014, the patient received the 1st dose of PEDIARIX (unknown) .5 ml, the 2nd dose of PEDIARIX (unknown) .5 ml, the 3rd dose of PEDIARIX (unknown) .5 ml, the 4th dose of PEDIARIX (unknown) .5 ml, the 1st dose of ROTARIX (oral) 1 ml and the 1st dose of Hib (unknown) .5 ml. On 27th October 2014, Not Applicable after receiving PEDIARIX, PEDIARIX, PEDIARIX and ROTARIX and an unknown time after receiving PEDIARIX, the patient experienced overdose, overdose and overdose. On 28th October 2014, the patient experienced death (serious criteria death and GSK medically significant), blood coming out from nose (serious criteria death) and blood coming out from mouth (serious criteria death). On 28th October 2014, the outcome of the death, blood coming out from nose and blood coming out from mouth were fatal. On an unknown date, the outcome of the overdose, overdose and overdose were unknown. The patient died on 28th October 2014. The reported cause of death was unknown cause of death. The reporter considered the death, blood coming out from nose and blood coming out from mouth to be almost certainly related to PEDIARIX, PEDIARIX, PEDIARIX, PEDIARIX and ROTARIX. Additional information received: The reporter was the patient's maternal grandmother. She reported that her family had dual citizenship. Her daughter gave birth to the child in one country and was planning to return to another country on 30 October 2014. The doctor advised the mother to bring child for immunizations prior to the trip. The patient was growing very well, at 88% growth percentile for his weight and height with no medical concerns, he passed all the tests. The patient was administered all three PEDIARIX shots at the same time on 27 October 2014, in the afternoon, along with ROTARIX and the Sanofi Pasteur flu shot. The mother reported that the baby received 2 shots on his left leg and 2 shots on his right leg, but the doctor stated in his records that the baby got one shot on his left leg and the others in the right leg. The grandmother stated that her daughter returned home with the baby after the doctor visit and the baby slept. When he woke up, she fed him and then put him to bed around 12 midnight or 1am on 28 October 2014. When she woke up around 7 am he was already dead, with blood coming out of his nose and mouth. They called 911 and the baby's mother tried to resuscitate him, then he was taken to hospital. At the hospital, the  family was told he had been dead for a few hours and was formally pronounced death on 28 October 2014. The grandmother was willing to be contacted and the family will seek legal action because they felt the death was caused by the vaccines administered that day.