Age: 0.6
Sex: F
Vaccine: DTAP, PNC, RV5, DTAP, PNC, RV5
Symptoms: Endotracheal intubation, Febrile convulsion, Gaze palsy, Gram stain negative, Haemoglobin decreased
Clinical narrative: Additional information provided adverse events, event details, test results, and outcome. Information regarding PREVNAR was received from a physician regarding a 7-month-old female patient who experienced febrile seizure, shock, pulmonary edema and respiratory failure. At 7 months of age, the patient received the third dose of PREVNAR on 26-Aug-2008. The patient also received the third dose of TRIPACEL (Aventis-Pasteur) and the third dose of ROTATEQ (Merck & Co Inc) on 26-Aug-2008. The patient's concurrent illnesses include eczema (mild) and nasal congestion (2 to 3 days prior to immunization). PREVNAR was administered on 26-Aug-2008. Concomitant medications were not reported. The patient is not taking any concomitant medications. On the morning of 26-Aug-2008 the patient was seen in the office for a routine six month well child checkup. "No problems". The patient was administered PREVNAR vaccine, received Tylenol drops post injection, and was taken to daycare. At 4pm the child was picked up at daycare and was "OK". At 6pm the patient's mother noted an increased temperature. While administering Tylenol, the patient experienced a jerking of her upper and lower extremities as well as her eyes being fixed. She was noted to be pale in color and not breathing well. 911 arrived and found the baby to be actively seizing. Prior to this incident, the patient had a 2-3 day history of nasal congestion but no noted fever. The patient was hospitalized with diagnoses of febrile seizure, respiratory failure, shock and pulmonary edema. In the emergency department, she was perfusing poorly, had a temperature of 101.3 deg. F., and was intubated. Pink frothy fluid was noted coming out from the ET tube. She was started on diuretic therapy, stabilized and transferred to another facility for admission to the pediatric intensive care unit. The patient was admitted to the hospital and placed on a ventilator. A full sepsis work-up came back negative. Pediatric infectious disease recommended a 7-10 day course of IV antibiotics. The patient's primary care physician does not believe that vaccines caused the seizure but is not sure of the cause of the seizure. A pediatric neurologist felt this was likely a complex febrile seizure and did not recommend daily anticonvulsive therapy but did recommend Diastat rectally for any seizures greater than 3 minutes. The patient was also treated with midazolam for unknown reason but this medication was considered the cause of generalized encephalopathy seen on an electroencephalogram that was performed. This study will be repeated as an outpatient. A pediatric cardiology consult and work-up was negative. On hospital day #4 the patient was extubated and did not require oxygen therapy. On hospital day #8 the patient returned to baseline (active, playful and appropriate for age) and was discharged to home. Discharge instructions included follow-up with pediatric neurology and private physician. Instructions were also provided for Tylenol, Motrin, and Diastat as needed. No additional information was available at the time of this report. These events were considered to be life threatening. Electroencephalogram (results: generalized encephalopathy) and laboratory test (results: A full sepsis work-up and viral studies negative) were done in 2008. Blood pH (results: 7.493 normal range 7.350-7.450) was done on 27-Apr-2008. On 26-Aug-2008 test results were: gram stain (results: of CSF <10 WBC's/LPF, <10 Epithelial cells/LPF No organisms seen); body temperature (results: 35.7 deg. C.); body temperature (results: 38.1 deg. C.); blood pH (results: 6.981 normal range 7.350-7.450); blood pH (results: venous 7.247 normal range 7.310-7.410); blood bicarbonate (results: arterial 17.4mEq/L normal range 22.0-27.0mEq/L); PO2 (results: 282.6 mmHg); PO2 (results: venous 48.4 mmHg normal range 35.0 - 42.0 mmHg); base excess (results: arterial base excess -15.3mmol normal range -2.0-2.0mmol); oxygen saturation (results: arterial 98.8% normal range 85.0-98.0%); carboxyhaemoglobin (results: arterial 0.4%); carboxyhaemoglobin (results: venous 0.1%); PCO2 (results: 74.9 mmHg); oxygen saturation (results: venous 73.0% normal range 85.0-98.0%); PCO2 (results: venous 62.3 mmHg normal range 41.0 - 51.0 mmHg); haemoglobin (results: venous 11.6g/dl normal range 12.0-16.0g/dl); CSF culture (results: no growth); blood test (results: venous ctO2 11.9%c2vo normal range 15.0-23.0%o2vo); blood culture (results: preliminary no growth); culture urine (results: preliminary no growth); viral test (results: RSV not detected (nasopharyengeal aspirate)); viral test (results: Influenza A + B SC negative (nasopharyengeal swab)); polymerase chain reaction (results: MRSA PCR negative (nares swab)); and body temperature (results: 101.3 deg. F.). On 27-Aug-2008 test results were: haemoglobin (results: arterial 11.6g/dl normal range 12.0-16.0g/dl); oxygen saturation (results: arterial 99.2% normal range 85.0-98.0%); carboxyhaemoglobin (results: arterial 0.1%); PCO2 (results: 33.3 mmHg); haemoglobin (results: arterial 11.0g/dl normal range 12.0-16.0g/dl); PO2 (results: 198.7 mmHg); PCO2 (results: 33.5 mmHg); carboxyhaemoglobin (results: arterial 0.3%); oxygen saturation (results: arterial 98.9% normal range 85.0-98.0%); and PO2 (results: 225.0 mmHg).