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This is VAERS ID 420077

Case Details

VAERS ID: 420077 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Unknown  
Vaccinated:2009-05-18
Onset:0000-00-00
Submitted: 2011-03-31
Entered: 2011-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X79P45I1U / 1 LG / IM

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Arachnoid cyst, Aspartate aminotransferase increased, Autopsy, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bicarbonate decreased, Blood bilirubin decreased, Blood chloride increased, Blood culture, Blood glucose increased, Blood lactic acid normal, Blood potassium increased, Blood sodium increased, Blood urea normal, Bronchitis, Cardiac arrest, Circulatory collapse, Congenital anomaly, Contusion, Death, Endotracheal intubation, Epistaxis, Febrile convulsion, Foaming at mouth, Gaze palsy, Haemoglobin decreased, International normalised ratio, Lipase increased, Lymphadenopathy, Lymphoid tissue hyperplasia, Microscopy, Neurological examination abnormal, Platelet count normal, Protein total decreased, Prothrombin time prolonged, Pyrexia, Respiratory tract congestion, Resuscitation, Skin haemorrhage, Subdural haemorrhage, Syncope, Tonic clonic movements, Unresponsive to stimuli, Upper respiratory tract infection, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Activated partial thromboplastin time, 99.5 sec; Alanine aminotransferase, 40 ul; Aspartate aminotransferase, 72 ul; Blood albumin, 1.8 g/dl; Blood alkaline phosphatase, 189 ul; Blood bicarbonate, 8 meq/L; Blood bilirubin, <0.1 mg/dL; Blood chloride, 112 meq/L; Blood culture, unknown, anaerobic blood culture had insufficient quantity; Blood glucose, 542 mg/dL, 337; Blood lactic acid, 19.1 mg/dL; Blood potassium, 7.1 meq/L; Blood sodium, 146 meq/L; Blood urea, 9 mg/dL; Haemoglobin, 6.7 g/dl; International normalised ratio, 2.7; Lipase, 252 ul; Microscopy, unknown; Microscopic comment: Summary of sections: 1. left anterior descending coronary artery, anterior papillary muscle, ductus x 2; 2. circumflex coronary artery, posterior papillary muscle, right atrium; 3. right coronary artery, septal base of heart, horizontal segment of septum; 4. right lung x 2; 5. right lung, larynx, edematous arytenoid cartilage; 6. liver x 2, spleen, pancreas, pituitary; 7. thymus; 8. rectum, small bowel, cecum; 9. bladder, prostate, paraesophageal lymph node, dark purple lymph node; 10. deep scalp hemorrhage; AA. right parietal white matter; BB. left hippocampus; CC. right hippocampus; DD. midbrain, cerebellum; EE. left temporal and parietal cortex at arachnoid cyst; FF. dura; Cardiovascular: Two sections of ductus arteriosus are 95-99% closed by fibrointimal thickening and calcification. Sections of coronary arteries and papillary muscles are unremarkable. Wavy fibers and edema are seen in the section of right atrium. The septal base section includes the bundle of His and is unremarkable. The horizontal section of the mid-septum has no disarray. Respiratory: The mucosal edema at the arytenoid cartilage noted grossly is not confirmed microscopically in section "E". Moderate submucosal inflammation is present with mild mucosal edema and lymphatic infiltrates submucosal glands. The sections of the right lung are well-expanded and have congestion, edema and hemorrhagic edema. Mild submucosal edema and lymphatic infiltrates are seen in the bronchi with focal eosinophils also seen in the submucosa of the bronchus. Sections of the left lung are similar but have less inflammation in the bronchi. Liver: Congestion. Hematologic: Spleen - congestion, follicular hyperplasia. Pancreas: Unremarkable. Genitourinary: Kidney - congestion, otherwise unremarkable. Bladder - unremarkable. Prostate - infantile and unremarkable. Endocrine: Thyroid gland - unremarkable. Adrenal gland - unremarkable, no fetal cortex remains (age-appropriate). Pituitary gland - unremarkable. Neurologic: Slight thickened leptomeninges are seen in all cortical sections and are most present in "EE" at the collapsed arachnoid cyst. No inflammatory infiltrates are seen. Perineural spaces are seen with vacuolated neurophil in the section of the left hippocampus in "BB". The right hippocampus section had a few extravasated red cells but is otherwise unremarkable. Vacuolation of cortex and white matter is seen in the section of right parietal love in "AA". No gray matter nodules are identified. The section of midbrain has subependymal nodules at the aqueduct but is otherwise unremarkable. The section of dura has a subdural membrane composed of loose connective tissue with focal extravastated red cells. An iron stain is negative with approximate control. A trichrome stain confirms the more pale-staining loose connective tissue of the membrane and the control is appropriate. Immunologic: The thymus has a markedly contracted cortex with slight starry sky appearance. The medulla has crowded Hassall corpuscles. Focal interstitial hemorrhage is seen. Sections of lymph nodes has prominent follicular hyperplasia. Gastrointestinal: Marked follicular hyperplasia is seen in Peyer patches in the cecum and rectum. The Peyer patches in the small bowel are less prominent. No mucosal abnormalities are seen. Musculoskeletal: A section of deep scalp has hemorrhage with focal fibrosis. Neurological examination, unknown; Brain weight - 1099 gram; Other than the previously described injuries the scalp is unremarkable. The skull is asymmetric. The fossae measure as follows: anterior 4.3/4.8, middle 4.5/4.8, posterior 5.3/5.8 cm right and left respectively. Other than the previously described injury the dura is unremarkable. The leptomeninges are glistening and translucent. Excess cerebrospinal fluid is seen at the base of the brain and an arachnoid cyst of approximately 2.5 cm is seen at the inferior temporal lobe. The tip of the left temporal lobe appears somewhat smaller than the right temporal lobe. The cerebral and cerebella hemispheres, brainstem, and proximal cervical spinal cord have no other gross abnormalities. The brain is fixed in formalin for further examination at a later date. The brain is re-examined at a later date. The dural hemorrhage is again identified as a red-brown focal stain of 2.5 cm at the left parietal surface. The arachnoid cyst seen at autopsy is collapsed and appears only as redundant leptomeninges at the inferior surface of the left temporal lobe. Multiple coronal sections of the brain reveal multiple gray matter foci of 0.4 x 0.3 cm in the posterior parietal lobe at deep sulci. Otherwise the sections are unremarkable, including the caudate nucleus, thalamus, basal ganglia and the cerebral ventricles which to do extend anterior to the tips of the temporal lobes. Immunologic system: Thymus weight - 45.1 grams; The thymus is pale pink with a few petechiae. The visualised lymph nodes are pink/gray and slightly enlarged. A 2.5 x 0.5 x 0.5 pale pink paraesophageal lymph node is seen. The mesenteric lymph nodes measure up to 1.8 cm. Physical examination, unknown; Body condition: intact. Rigor: complete. Livor: faint purple. Hair: approximately 1/4 inch curly-kinky head hair, no beard or moustache noted. Eye: closed, conjunctivae pale, irides brown, pupils 3 mm, one petechial hemorrhage of less than 1 mm at right eye. Teeth: natural and in good repair. The body is that of a normally developed, normally nourished child, appearing older than the stated age of 17 months, of average build, with no significant abnormalities of head, trunk, extremities and genitalia. The mucous membranes are pale. The body is clad in a disposable diaper which is discarded. The length is greater than 97%-ile for age. The weight is approximately 78%-ile for age. The weight for length is 35%-ile. Evidence of medical intervention consists of an endotracheal tube secured in the mouth, intravenous access and arm board with 0.6/L sodium chloride in right arm, intraoseous catheter with 0.9/L sodium chloride in right lower leg, and needle puncture marks on the left inner arm and left hand. Injuries: 1. A slight fresh abrasion is present at the upper lip. A small hemorrhage is seen at the right side of the tongue near the tip. (The child had been intubated and the tube is seen). 2. No other external injuries are identified. Internal examination reveals a right parietal deep scalp hemorrhage of 5/8 x 1/4 inch, and two small deep scalp hemorrhages of 1/4 x 1/8 at the midline and left parietal scalp. Continued internal examination reveals an intact skull, a focus of subdural blood of 1 inch diameter, and no additional injuries of the brain or it''s coverings. 3. No other injuries are seen. Internal examination: Body cavities: The right and left pleural cavities each contain 20 ml of serious fluid. The pericardial cavity contains 5 ml of serious fluid. The peritoneal cavity contains no significant accumulation of fluid. The surfaces are smooth and glistening. Cardiovascular system: The heart is not grossly enlarged. The weight is not recorded. The epicardial surface is unremarkable. The coronary arteries have right dominant distribution. The fossa ovalls measures 1.2 cm and is closed. The myocardium is medium tan-pink with no focal lesions and the free walls measure 0.2 and 0.8 cm, right and left respectively. The interventricular septum measures 0.7 cm. The circumferences of the cardiac valves measure: tricuspid 7.2, pulmonic 4.6, mitral 6.2 and aortic 3.7 cm. The aorta and the remainder of the vascular system are unremarkable. Respiratory system: Right lung weight - 190 grams. Left lung weight - 171 gram. The soft tissue at the arytenoid cartilage is slightly edematous. The larynx is otherwise unremarkable as is the trachea with light pink mucosa and frothy edema fluid. The hyoid bone and laryngeal cartilages are intact. The pleural surfaces of the lungs are light pink anteriorly and are dark purple posteriorly. The lungs are subcrepitant to the palpitation and soft on section. The cut surfaces are purple-red, congested and edematous. The distal airways contain edema fluid. The pulmonary vessels are unremarkable. Gastrointestinal system: The esophagus is remarkable. The gastroesophageal junction is sharply defined. The stomach contains 150 ml of pale, slightly translucent liquid, french fries and unrecognisable food particles. No hemorrhage is present in the proximal gastrointestinal tract. The distal bowel is hyperemic and congested with dark purple contents. The colon is slightly congested. Peyer''s patches are prominent. The appendix is present. Liver: Liver weight - 514 grams. The liver is purple-red, of soft consistency on palpation and on section. The hepatic architecture is unremarkable. The gallbladder contains less than one ml of dark yellow bile and no stone. The extrahepatic biliary trees is patent. Spleen: Spleen weight - 33 grams. The splenic capsule is dark purple. The spleen is soft on section and the cut surface is dark purple with prominent white pulp. Pancreas: The pancreas is unremarkable. Urinary: Right kidney weight - 52.1 grams; Left kidney weight - 50.6 grams. The renal capsules strip with ease. The kidneys retain fetal lobulation. The bladder contains scant bloody urine. Reproductive: The male internal organs are infantile and grossly unremarkable. Endocrine: The thyroid gland and adrenal glands are grossly unremarkable. No abnormalities are present in the pituitary gland. Platelet count, normal; Normal "hi norm"; Protein total, 3.5 g/dl; Prothrombin time, 28.9 sec; White blood cell count, 8.4 k/mm3
CDC Split Type: PHHO2010US12589

Write-up: 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.


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