Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastrooesophageal reflux disease, Haemorrhage, Irritability, Oral candidiasis, Petechiae
Clinical narrative: This retrospective pregnancy case was reported by a consumer via other and described the occurrence of asphyxiation in a male neonate exposed to Tdap in utero. The mother received the product. Co-suspect product exposures included FLUARIX, ENGERIX B pediatric, PEDIARIX, ROTARIX, ACTHIB and PREVENAR 13. On an unknown date, the mother received Tdap and seasonal influenza vaccine. On 19th April 2013, the mother received ENGERIX B pediatric. On 19th June 2013, the mother received PEDIARIX and ROTARIX. On an unknown date, the mother received ACTHIB at an unknown dose. On 19th June 2013, the mother received PREVENAR 13. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The neonate was exposed to Tdap during the second trimester of pregnancy. At [weeks gestation], the neonate was born via vaginal delivery. The neonate was diagnosed with apnea (serious criteria GSK medically significant), irritability and dyspnea exacerbated. On 5th July 2013, the neonate experienced asphyxiation (serious criteria death and GSK medically significant). On an unknown date, the neonate experienced apnea (serious criteria GSL medically significant), breathing arrested (serious criteria GSK medically significant), unresponsive to stimuli (serious criteria GSK medically significant), difficulty breathing, snoring, eye discharge, oral thrush and maternal exposure during pregnancy. The neonate was treated with ZANTAC and TYLENOL. On an unknown date, the outcome of the asphyxiation was fatal and the outcome of the apnea, breathing arrested, unresponsive to stimuli, apnea, difficulty breathing, snoring, irritability, eye discharge, oral thrush, dyspnea exacerbated and maternal exposure during pregnancy were unknown. The neonate died on 5th July 2013. The reported cause of death was asphyxia. An autopsy was performed. The autopsy determined cause of death was unresponsive to stimuli, petechia and visceral congestion. It was unknown if the reporter considered the unresponsive to stimuli to be related to Tdap and seasonal influenza vaccine. It was unknown if the reporter considered the asphyxiation, apnea, breathing arrested, difficulty breathing, snoring, irritability, eye discharge and oral thrush to be related to ENGERIX B pediatric. It was unknown if the reporter considered the asphyxiation, apnea, irritability and dyspnea exacerbated to be related to PEDIARIX and ROTARIX. Additional details were provided as follows: This case was retrieved from a media research. The patient's mother received Tdap and flu vaccine during her 2nd trimester of the pregnancy. At 40 weeks of gestation, the patient's mother went into labor in a medical center. She was tested positive for Group B streptococcus and was given 2 doses of the antibiotic penicillin. Rest of pregnancy and labs negative. Since discharge home, has been healthy without fever. Soon after, the patient was born unresponsive, weighing 9 pounds and 2 ounces and had to be resuscitated immediately. After he was resuscitated, the patient was deemed in good enough health and then was injected with the vitamin K shot and hepatitis B vaccine. The two combined shots contain approximately 350 mcg of aluminum and both are linked to breathing problems, among other things. By the time the patient was 3 weeks old, his mother noticed him having gasping episodes while sleeping in his bassinet. When he was awoke, he let out a snoring sound as he would catch his breath, then he would go back to bed. When the patient was 5 weeks old, his apnoea episodes started occurring more frequently, about once every hour. The patient's mother had to blow into her son's mouth and nose to get him breathing again. On 26th May 2013, the patient's mother rushed her son to the emergency room at hospital, begging for help. She knew something was very wrong, but the doctor would not listen to her and wrote the patient's breathing problems off as reflux and gave her a prescription for ZANTAC and told her to follow up with his paediatrician. She felt helpless and was frustrated as they would not hook up the patient to a breathing monitor. At this visit, the patient's emergency documentation included that a 5 week old male, previously healthy, who presented with abnormal respirations as per his mom. The patient had been having one gasping episodes for the last 2 weeks which occurred once a night when he was sleeping and was not associated with any other symptoms. He was sleeping and his mom hears him gasp more than 1 time, which woke him up for a few seconds but then he easily goes back to bed. No perioral or acrocyanosis noted. Last night he would have gasping about once an hour. Also has been having some left eye purulent discharge and oral thrush. The patient was still being breastfed. He was breastfed for several weeks and then switched to formula. He had no congestion, no runny nose, and no swollen eyes, none of the things you would associate with a food allergy. Believing the doctors knew best, the patient's mother gave her son the prescription ZANTAC. This did not help him. The patient's apnoea spells continued while she waited for him to be seen by his paediatrician. The patient's mother found out the paediatrician and was required to submit a referral to the hospital for them to test the patient at their sleep disorder clinic. On 7th June 2013, the paediatrician sent the referral for them to do apnoea testing on the patient. An appointment was made for him to be seen by a nurse practitioner at the sleep clinic the following Monday. By this time, the patient's mother had to breathe in her son's nose and mouth more than once when he stopped breathing. After getting home from that appointment, the patient received a phone call about an hour later and was told Monday's appointment was cancelled. She was told the patient could not be seen by a nurse practitioner because he was too young and that only a doctor of medicine (MD) could see him, which did not make sense. The patient's mother was told they would put him on a waiting list to be scheduled to be seen. She was so shocked and upset at this. None of the doctors were doing anything to help her son. Weeks went by and the patient was still not scheduled to be seen. Then on his two-months check-up approached. The patient's mother took all three of her children in to receive the vaccines on time, but she did not know vaccines were linked to apnoea and breathing problems. At the patient's two-month well-baby check-up, the doctor neglectfully recommended him to receive the routine vaccines. The doctor assured his mother that the vaccines were safe and signed off for the nurse to vaccinate the patient with 8 more vaccine doses, even though his breathing problems had not been addressed. The patient's mother entrusted the doctor with her son's life and signed the paper, giving consent to vaccine. On 19th June 2013, when the patient's weighed almost 15 pounds, the nurse administered the PEDIARIX, ACTHIB, PREVENAR 13 and ROTARIX, via needle three injections and one oral dose, for a total of 8 vaccine doses. After the patient received those two-month vaccinations, he was cranky and was given TYLENOL, which was recommended by the doctor. The patient's breathing issues worsened. Days passed and the apnoea spells continued. The patient's mother felt helpless and did not know what to do while waiting for the patient to be scheduled for an appointment. She would prop up the patient on his Boppy pillow and on one occurrence, she witnessed the patient holding his face and not breathing for fifteen seconds. The patient's mother was so scared because when he would sleep, he was gasping for air more often and his apnea episodes was worsened following the two-month vaccines, but none of the doctors would help him. On 4th July 2013, after an eventful firework celebration on Independency Day, the patient was laughing and playing on his Boppy pillow. He went to sleep at around 11:30 pm, in a natural, elevated position, cradled in his mother's arm, on his back. He had a bassinet he often slept in but sleeping next to mom was more preferred this night. On 5th July 2013, around 5:08 am, five hours after they fell asleep, his mother woke up thinking it was odd that the patient did not wake up yet, because he would normally wake up sooner, to feed. The patient was still in the same position he fell asleep in. He was on his back and completely face up. His mother needed to get up and when she moved her arm out from under him, he rolled off her arm and onto his face. He did not try to move. The patient's knew something was wrong. She picked him up and yelled his name. The patient was still warm, but his lips were cold. She yelled for his dad to call. It took the ambulance eight minutes to get to them and they only lived two blocks away. The ambulance showed up and emergency responders took the patient and tried to revive him. All attempts to resuscitate the patient were unsuccessful and he was pronounced dead at the hospital, at 5:51 am. He was only two and a half months old. When the patient died, the emergency responders noted that he had a significant amount of blood in the back of his throat and that no foul play was suspected. The patient's parents were separated from each other and they felt like being held hostage and treated like criminals. Once the patient's parents were allowed to leave the hospital, less than 2 hours later, hospital phoned his mother, to ask if she would give permission for them to donate the patient's usable organs and tissue. The patient's mother could not handle this and was so upset and told them not to touch her baby. The patient's immediate cause of death on his autopsy report was labeled as probable asphyxiation, due to co-sleeping with an adult, leaving his mother feeling guilty she was responsible. It was ruled accidental. He had a significant amount of blood in the back of his throat and many of his organs were congested. His body was starved of oxygen. There were no signs of suffocation when he died, he was on his back and no object was obstructing his airways. The patient had no blood vessels that burst in his eyes, he had no petechiae in his eyes, no swelling of his face, no bruising on his face, no blood pooling in his face and his face was not discoloured, which are things a person would show signs of if they truly suffocated. Major findings during in the patient's autopsy report were probably asphyxia, history of being found unresponsive, after co-sleeping with adult, thymus and lung petechiae and severe congestion of internal organs. Based on these findings, the patient's immune system was overstimulated. These findings on his autopsy report are typical of someone who suffered a severe reaction, associated with an immune system or asthma related inflammatory response. Petechiae found in the thymus and lungs represents his capillaries were bleeding, where blood was able to leak into the skin. Vaccines can affect the thymus, but no vaccines were mentioned in his autopsy report. In viewing the vaccine package inserts to the vaccines given to the patient, one can read that sepsis, apnoea, breath holding, SIDS, allergic reaction, etc. are listed as associated risks to these vaccines. The patient's mother was not informed by the paediatrician that all of the vaccines the patient received were associated with breathing problems and apnea as possible adverse reactions, which was stated on each of the vaccine package inserts to the vaccines given to the patient. Had the mother knew this information, she wouldn't have allowed him to be vaccinated further. The patient's death was plausibly an iatrogenic death, due to a medical intervention that involved vaccination. This should not be ignored and his mother, along with an endless number of other parents, wanted her child's death certificate changed to acknowledge vaccines as the most plausible contributing factor in the death of their child.