Age: 0.17
Sex: M
Vaccine: MNQ
Symptoms: Upper respiratory tract infection, White blood cell count normal
Clinical narrative: Initial report received on 19 Aug 2010: This patient was enrolled in study to evaluate the safety of Novartis MENACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants. Study vaccination was commenced on 18 May 2009. The patient received the second dose on 20 Jul 2009, the third dose on 21 Sep 2009 and the fourth on 22 Mar 2010. On 18 Aug 2010, the patient died. No further information was available. In the absence of the investigator causality, Novartis has processed the case as suspected for reporting purposes. The case will be further reassessed upon receipt of follow-up information. Follow up received on 20 Aug 2010: At the time of death, the child (patient) was in the custody of a friend of the father. They were in a car and the friend pulled over because the child did not look right. They then went to the emergency department. The mother stated that the child was already deceased by the time she got to the emergency department. The investigator assessed the event as not suspected to be related to the study vaccine. Follow up received on 20 Aug 2010: On 13 Aug 2010, the patient was seen in the emergency department (ED) for possible seizure with congestion and fever. The patient's eyes rolled up in his head and had foaming at the mouth. The patient experienced generalized tonic-clonic movements which lasted 30 seconds to a minute. The patient was diagnosed with upper respiratory infection (URI) and fever. The patient received treatment with MOTRIN. The patient was discharged after around 4 hours in good condition with an impression of febrile seizure. On 18 Aug 2010, the patient was in the seat in a car next to 'step mother' and experienced sudden syncope episode and cardiac arrest. The report also stated the patient experienced sudden epistaxis. The patient was intubated and given drugs (atropine and epinephrine). Cardiopulmonary resuscitation (CPR) was performed en route to the ED. The patient died at 17:38. Follow up received on 24 Aug 2010 prior to previous follow up circulation: The investigator assessed all events as not suspected to be related to the study vaccine. Follow-up received on 13 Dec 2010: The cause of death was not yet received by the investigator. Follow-up received prior to circulation of previous follow-up on 14 Dec 2010: The patient was presented with upper respiratory tract infection on 09 Aug 2010 and was seen in ER. The patient was discharged in 4hrs after observation. The patient developed febrile seizure on 13 Aug 2010 at 16:30 hrs. The investigator did not suspect a relationship between the event and the study vaccine. Batch review report (reference number 78559) received from quality assurance department on 12 Jan 2011: Based on the document review, it was stated that the concerned MENACWY batch number X79P45I1U was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received on 24 Mar 2011: on 18 Aug 2010, after resuscitation had started, the patient also had blood coming from his mouth. The patient's diagnoses on the autopsy examination were as follows, focal deep scalp hemorrhage, very focal, 2.5 cm area of organising subdural blood at left parietal dura; left temporal lobe arachnoid cyst of approximately 2 cm; mild laryngeotracheobronchitis with follicular hyperplasia of lymph nodes, Peyer's patches and spelenic white pulp; perimortem laboratory studies during resuscitative effort consistent with history of prolonged hypoxic-ischemic condition. No other significant pre-existing disease or injury was identified. The autopsy examination revealed a slightly asymmetric skull and an arachnoid cyst at the left temporal lobe, small deep scalp hemorrhages and a very small focus of subdural blood. The investigator stated that the arachnoid cyst is a congenital condition, which is usually identified as an incidental finding rather than a lesion causing death; the leptomeningeal thickening seen microscopically is related to the cyst and is not related to the study vaccine. Furthermore the investigator stated that febrile seizures are usual benign conditions, rarely the children of parents who have experienced febrile seizures are found unresponsive after sleep. The circumstances of this patient's death are different and no history of parental febrile seizures in childhood are known. Microscopic findings were consistent with the history of recent respiratory illness but were not sufficient to account for the history of sudden unresponsiveness or death. The abnormal laboratory results obtained during the resuscitative attempt were nonspecific and consistent with the prolonged cardiovascular collapse documented in the medical records. The small organising subdural blood and the small deep contusions were not sufficient to cause death, how they occurred was unclear. Toxicologic examination revealed only the drug atropine used in resuscitation. The investigator concluded that based on the scene circumstances and autopsy findings, as well as review of medical records and law enforcement investigation, the cause of death is undetermined. The Novartis medical safety physician has assessed arachnoid cyst and bronchitis as non serious. In the absence of causality assessment for hemorrhage, arachnoid cyst, laryngeotracheobronchitis, follicular hyperplasia of lymph nodes, Peyer's patches and spelenic white pulp, Novartis has processed the case as suspected for reporting purposes.