Sex: U
Vaccine: PPV
Symptoms: Body temperature increased, Pneumococcal bacteraemia, Streptococcal bacteraemia, Streptococcus test positive, White blood cell count increased
Clinical narrative: This is a literature report from the Pediatrics. This author reported similar events for two patients. This is first of two reports. The primary objectives of this study were to determine the rate of bacteremia per febrile episode among sickle cell disease (SCD) patients presenting to the emergency department (ED) and the safety of outpatient management of febrile patients with SCD. This was a retrospective cohort study of febrile patients with SCD presenting to the ED of Hospital between 01Jan1993 and 31Dec2010. Hospital is an urban, tertiary care hospital with an annual ED volume of 50,000 to 60,000. The authors identified patients from the registry of the hospital Comprehensive Sickle Cell Clinic with homozygous sickle cell anemia (SS), sickle-hemoglobin C disease, sickle-bo-thalassemia, or sickle-beta- thalassemia. Their medical records were then reviewed to identify all ED encounters. ED episodes were included if patients were less than 21 years of age; had a temperature more than 38.5 degrees Centigrade in the ED, at home, or at a transferring facility; and had blood obtained for bacterial culture. Febrile ED episodes were excluded if patients received any antibiotic treatment other than baseline oral antibiotic prophylaxis before evaluation, the ED records were not available, or there was a previous ED evaluation for fever within the previous 7 days. Subjects presenting with temperatures between 38.0 degree Centigrade and 38.5 degree Centigrade were assessed only for their rate of bacteremia. For follow-up, the authors reviewed the ED, inpatient, and clinic medical records for events after the febrile episode to assess for any mortality or morbidity. During the 18-year study period, 627 SCD patients had 2088 ED encounters for fever, and 1118 met the study criteria. Thirty-eight patients met criteria for ill appearing, which was associated with increased rates of supportive care, hospital admission, and ICU level admission (P less than .01). Cultures of blood obtained during 9 of 1118 (0.8%; 95% confidence interval [CI]: 0.3%-1.3%) febrile episodes grew a pathogen. Of the 9 episodes, none of the patients were ill appearing or required supportive care while in the ED nor did any morbidity or mortality occur. There were two cases of S pneumoniae bacteremia. Both cases of S pneumoniae bacteremia occurred after the introduction of the heptavalent pneumococcal conjugated vaccine. One patient was fully immunized. The other patient had received 1 of 2 recommended 23-valent pneumococcal polysaccharide vaccinations and 1 of 2 recommended heptavalent pneumococcal conjugated vaccinations. The pneumococcal serotypes were 15A and 15C; both were non-vaccine serotypes and both were susceptible to penicillin. A 13-year-old patient of an unspecified ethnicity and gender received the pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (MANUAFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included homozygous sickle cell anemia. The patient's concomitant medications were not reported. In May2003, the patient experienced streptococcus pneumoniae bacteremia (non-vaccine serotypes: 15A and 15C), which required hospitalization. The patient underwent lab tests and procedures which included temperature: 39.3 degrees Centigrade on an unknown date and white blood cell count (WBC): 12.48 x10 9/l on an unknown date. The action taken in response to the event for pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. Therapeutic measures were taken as a result of streptococcus pneumoniae bacteremia and included treatment with parenteral antibiotic therapy. The clinical outcome of the event, streptococcus pneumoniae bacteremia, was unknown. As per the author's discussion, the authors found a low rate of bacteremia (0.8%) among acutely febrile patients with SCD and no associated morbidity or mortality associated with outpatient management. Physicians should strongly consider outpatient management for non-ill-appearing children with SCD and a temperature more than 38.5 degree Centigrade after blood for culture was drawn and empirical parenteral long-acting antibiotics administered, provided there are no other reasons for admission, the patient has at least 1 functioning telephone number, and the patient was able to promptly return to the ED should their blood culture grow a pathogen. The authors believed that febrile SCD patients managed as outpatients should have follow-up in 24 hours to assess their clinical condition (eg, to check for possible dehydration, acute pain crisis, or acute chest syndrome) but that a second dose of antibiotics was not generally required because the vast majority of blood cultures grow within 24 hours. A temperature of 38.5 degree Centigrade should be used as a testing threshold to obtain blood for cultures. Pfizer is marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) has submitted the same report to the regulatory authorities. Sender's Comments: Reported event "streptococcus pneumoniae bacteremia: serotypes: 15A and 15C" (non- PREVENAR 7 preventable serotypes) more likely represents coincidental bacterial infection, which considered not related to PREVENAR 7. 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-2018027807 same event/drug/article, different patient.