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Write-up: Case number PHHY2015IT026937, is a combined initial spontaneous report from a physician via Novartis employee and a healthcare professional via health authority (HA, reference number: 297337) received on 05 Mar 2015, with a follow up report received from the quality assurance department (QA, reference number: 355706) on 06 Mar 2015, with a combined follow up report received from a biologist via Novartis employee and a lay press newspaper article (journalist) on 05 Mar 2015 and from a lay press newspaper article on 06 Mar 2015, with a combined follow up report received from a lay press article and the QA department (reference number: 355706) on 09 Mar 2015 and 10 Mar 2015 respectively, with a follow up report received from the HA on 13 Mar 2015. This report refers to an 11 weeks old male neonate. Medical history and concomitant medications were not reported. He was vaccinated with first dose of BEXSERO (batch number: 131301, expiry date: 31 Mar 2015) on 26 Feb 2015. Further to the vaccination, the patient showed unspecified increased polymerase chain reaction (PCR) value, neutropenia, thrombocytopenia (septic shock). On 03 Mar 2015, the pediatrician visited the patient''s home and suggested hospitalization due to severity of conditions including fever. On 03 Mar 2015 at hour 12:48, he was admitted to a pediatric ward due to hyperpyrexia for 6 hours. At the pediatric ward it was noted that the patient was in poor clinical conditions, sufferance behavior, pale and septic color, dehydrated, tachycardic pulse (heart rate (FC) was 190/minutes). At the same department venous access was found. He was given Ceftriaxone (300 mg) and Methylprednisolone (10 mg) endovenously. The ceftriaxone showed no response. The condition worsened. The patient was transferred another emergency department from the pediatric ward of the local town with the assistance of the pediatrist and of an anesthesiologist at 13:50 hours. During hospital admission, there was a marked increase in C-reactive protein level with a value of 5.88 mg. He was in critical conditions. The patient had paleness of the skin, marble-like appearance, hypostasis phenomena, peripheral pulses filiform, hypothermia, tachyarrhythmic cardiac sounds, sensorium obnubilation with tendency to the soporous status. Hematobiochemical blood drawn has been performed and hemogasanalysis through venous access at the femoral vein showed very severe mixed acidosis. His blood pH was 6.89, pCO2 was 62, EB was 20.8 and bicarbonate was 11.8. Due to this observation, a tracheal intubation was performed and mechanical ventilation was started. An electrocardiogram showed evidence of sinus tachycardia at heart rate of 195/minutes with tendency to bradycardia crisis. For this reason, endotracheal Adrenaline was given along with Hydrocortisone at anti-shock dosage (250 mg) and sodium bicarbonate (20 cc) was given endovenously at 14:10 hour. At hour 14:20, in order to be able to find a venous access more congruous and taking into account the extreme criticality of the situation, an intra-osseous puncture under emergency was performed. A physiological solution (unspecified) was infused at anti-shock velocity (40 ml/hour). His arterial pressure was not detectable (Dinamap method), unique vital parameter was detectable in the ECG. He was given bicarbonate infusion at a dose of 10 cc at 14:25 hours. On the same day at 14:40 hours, 20 mg of Ceftriaxone was administered endovenously. At 14:46 hour, a chest-abdominal X-ray was requested which showed reduction in the lung diaphany at the III medium superior of the right lung without representation of the intestinal meteorism with distension of one intestinal ansa projectively in the mesogastrium. At 14:50 hour, a peripheral blood smear test was performed which showed evidences of leucopenia with severe neutropenia (700/mmc) and thrombocytopenia (59.000/mmc). On the basis of this result (highly evocative for a septic picture) a Gentamycin was administered endovenously at a dose of 12.5 mg at 15.00 hours. His condition was extremely critical with succeeding bradycardia at 15:10 hours. He was given prolonged external cardiac massage and further bicarbonate and adrenaline infusions were performed. An ECG recording shows idioventricular rhythm with enlarged QRS at heart rate (FC) of 65 to 70/minutes. At 15:30 hour, there was absence of response to any stimulation, fixed mydriasis and extreme bradycardia resistant to the resuscitation maneuvers. At 15:50 hours, there was no cardiac electrical activity. Death was certified due to septic shock. Autoptic evaluation was requested. On 04 Mar 2015, a blood sample of the pediatric patient was sent to an institute where the search for bacterial DNA with CRP real time method gave positive outcome for Neisseria meningitidis B serum group. Biologist highlighted that a single lower dosage of vaccination, was not considered sufficient to confer protection. In a lay press it was reported that a syndrome of Waterhouse-Friderichsen (a form of complication to meningitis) killed the infant. Initially BEXSERO was considered as a possible cause of death, but the results of the analysis did not confirm this hypothesis. It was possible that, when he was vaccinated and seemed to be healthy, the infant was already incubating the disease. The physicians confirmed that there would be no correlation between the events and the vaccine administered one week prior. A tissue sample was collected from the body of the baby which would be subjected to histological examination. Based on analysis performed on the first blood samples, it was reported that the baby had been hit by an event "fulminant infectious." On 05 Mar 2015, autoptic examination was performed but definitive results were not available. The causality of the event septic shock was reported as suspected by health authority and for the event syndrome of Waterhouse-Friderichsen was reported as non-suspected by the physicians. Based on the performed review on BEXSERO batch 131301, there is no evidence of any objections which occurred during the manufacturing process of finished product, including adjuvant and components used, that could compromise the quality of the product or that may be potentially related to the reported events. QA confirmed that the involved batch is compliant with internal procedures and with cGMP requirements. Non-significant follow up report received from the quality assurance department (QA, reference number: 355706) on 06 Mar 2015: Updated QA reference number. Combined follow up report from a biologist via Novartis employee and from a lay press newspaper article (journalist) received on 05 Mar 2015 and from a lay press newspaper article received on 06 Mar 2015: Added event (syndrome of Waterhouse-Friderichsen), analysis information and causality of the event. Follow up report received from the QA department (reference number: 355706) on 10 Mar 2015: Updated BEXSERO vaccine batch review report. A combined follow up report received from a lay press article and the QA department on 09 Mar 2015 and 10 Mar 2015 respectively: Updated reporter''s statement and batch review report. Follow up report received from the HA on 13 Mar 2015: Updated details on hospitalization, condition during transfer to a second hospital, event details, laboratory tests, procedures and treatments received, cause of death and other clinically relevant information in the narrative.
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