Age: 0.4
Sex: U
Vaccine: PNC13
Symptoms: Grunting, Hydrocephalus, Lethargy, Meningitis pneumococcal, Motor developmental delay
Clinical narrative: This is a literature spontaneous report. The authors reported for 7 patients. This is the second of 7 reports. The 7 patients described in this series were identified through direct patient care provided by the authors and by a systematic search of medical records from January 2004 until December 2014 using ICD-9 (International Classification of Diseases, Ninth Revision) codes for pneumococcal meningitis (320.1), bacterial meningitis (320), and streptococcal meningitis (320.2). Diagnoses were verified by review of the medical record from which pertinent clinical information and laboratory data were abstracted. Meningitis was defined as pleocytosis in the cerebrospinal fluid (CSF) and a blood or CSF culture positive for S pneumoniae. The cluster of cases of pneumococcal meningitis occurred between September 2013 and December 2014. The authors identified 7 cases of pneumococcal meningitis presenting in children aged 5 months to 6 years between Jul2013 and Dec2014. This case refers to a 5-month-old patient of unknown gender. The patient received 2 doses of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose for immunization. The patient was partially immunized with pneumococcal 13-val conj vac (dipht CRM197 protein). On an unspecified date the patient presented symptoms of fever, poor feeding, grunting with lethargy was hospitalized and diagnosed with pneumococcal meningitis. The duration of the symptoms was of 36 hours. A blood culture showed positive results. A CSF analysis was remarkable for very modest pleocytosis the patient had a positive CSF Gram stain for Gram-positive diplococci with cultures positive for S. pneumonia serotype 15B. Other lab data included Nucleated Cells (CSF): 46/mm3, Glucose (CSF): 15mg/dl, CSF protein: 135mg/dl, CSF red blood cell count: 166/mm3.  Complications observed in hospital included seizures, respiratory failure, urinary tract infection, poor feeding, hydrocephalus requiring a shunt. The patient survived but had the following subacute sequelae: unilateral severe hearing loss and had a cochlear implant, developmental regression with sustained speech and motor delays hydrocephalus, abnormal gait and sustained exotropia. Outcome was unknown. The authors reported a cluster of cases of pneumococcal meningitis in young infants and children in the pneumococcal 13-val conj vac (dipht CRM197 protein)  era associated with a very high degree of morbidity and mortality. All patients in this cluster experienced neurologic sequelae in contrast to rates of 40% to 63% reported in the recent literature. There are several possible explanations for the poor outcomes in these cases. The decreasing incidence of meningitis in general may lower practitioners' suspicion for bacterial meningitis, which may lead to delayed diagnosis. The modest pleocytosis observed in 5 patients may reflect a less robust inflammatory reaction which in turn may be associated with fewer early symptoms, also leading to delayed diagnosis. The main limitation to this brief report is that it is not population-based, and we are thus not able to comment on incidence rates. Accordingly, the high degree of observed morbidity and mortality, in addition to the clustering of cases, may simply be a chance event. Nonetheless, it is alarming that 7 of 14 cases occurring during a 10-year period were observed during 17 months. Pfizer is Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.; Sender's Comments: Serotype 15 is not contained in Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein), therefore a lack of efficacy in this patient can be excluded. The Company considers the Pneumococcal meningitis and its complications unrelated to Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2016518540 different patient, different event and same drug.