Age: 1.46
Sex: M
Vaccine: FLU3, DTAPIPVHIB, FLU3
Symptoms: Sleep disorder, Somnolence, Tremor, Upper respiratory tract infection, Urine analysis normal
Clinical narrative: Initial report was received 02 February 2011 from a consumer who is the patient's parent, which involved a case of misuse. An 18-month-old patient had received an injection of FLUZONE, lot number UT3574CA (route and site of administration not reported) on 16 September 2010. Fifteen days later on 01 October 2010, the patient experienced a seizure and fever. The event required a doctor's visit and/or emergency room visit and hospitalization of two days duration. According to the reporter, the patient has had sleep disturbance, also reported as "can't rest", since the seizure occurred. The patient was seen by a neurologist who prescribed Melatonin to aid sleeping. The patient had a history of retinoblastoma (both eyes) which was diagnosed at two weeks of age and required nine rounds of chemotherapy and radiation as corrective treatment. At the time of vaccination, the patient was in remission. The patient also had an allergy to CARBOPLATIN. The patient had received five prior influenza vaccinations which consisted of one dose of FLUZONE (2010-2011 season) on 03 August 2010, two doses of influenza vaccine for the 2009-2010 season (manufacturer, lot numbers and administration dates not reported), and two doses of 2009 A/H1N1 vaccine (manufacturer, lot numbers and administration dates not reported). He had not experienced any adverse events following prior vaccinations. According to the reporter, the event outcome was recovered; however the event of sleep disturbance was described as ongoing at the time of the report. No additional information was provided at the time of the report. Follow-up information received from a physician on 21 February 2011. Medical records were received that included hospital records and copies of physician visit notes and immunization records. The subject's medical history includes recurrent bilateral retinoblastoma that had been treated with chemotherapy/radiation and 9 laser ablations of the eyes. The last dilated eye exam under anesthesia was in August 2010 that showed full regression of retinoblastoma in both eyes. Family history includes father who had retinoblastoma. Per immunization record, the patient had received dose 1 of Hepatitis B vaccine on 02 April 2009, and on 03 August 2010 he received dose 1 of PENTACEL, PCV vaccine, and previously reported first dose of FLUZONE. The patient was seen in the physician's office on 16 September 2010 for re-check of his weight and to receive his immunizations. Three days prior, his Broviac Port-A-Cath used for chemotherapy treatments had been removed and the patient was doing well. The patient weighed 21 pounds 4 ounces (9.94 kg (8%ile)) which was up from his last visit. He was behind on his normal immunization schedule due to his chemotherapy treatments and received that day a second dose of PENTACEL, and a second dose of FLUZONE. Lot numbers were not reported for either vaccines. Diagnosis: underweight, stable retinoblastoma. The patient was scheduled to receive MMR and Varicella vaccination in 6 weeks. On 01 October 2010, i.e., 15 days post vaccination at around 13:22 pm, the patient presented in a postictal state to the emergency room via EMS after experiencing a sudden single episode of new onset generalized tonic-clonic seizure that day in the home around 12:05 pm. The seizure lasted approximately 2 minutes and was moderate in severity. The patient had no prior history of seizure activity, no current fever illness, and no history of foreign travel in the past 10 days; however the grandmother had reported the patient was hot/warm to touch when she picked him up from his nap that day. The mother reported that the patient was staying with his grandmother that day when he had a seizure around 12:05 pm that lasted approximately 2 minutes. The patient's eyes had rolled back and he had body jerks that were followed by generalized tonic-clonic type shaking of the entire body. Afterwards, the patient cried frantically for 15 minutes, and then was in a postictal state being lethargic and sleeping till EMS arrived, and was still in that state on arrival to the emergency room. EMS team had not observed any seizure activity. Per the mother the patient had been afebrile but stated the patient had experienced an upper respiratory infection that week and had just been evaluated in the physician's office the previous day for acute conjunctivitis contracted through his day care. At that time, the patient was started on VIGAMOX and had significant improvement the day he had the seizure. The mother also reported the patient had been given BENADRYL around 11:00 am on 01 October 2010 for a runny nose. Other home medications included ZYRTEC for runny nose. Physical examination in the emergency room revealed the patient to be somnolent arousing to touch, but quickly fell back to sleep. Breath sounds were clear and equal bilaterally with diminished breath sound to the left lower lobe, but with good air exchange. The rest of the physical exam was within normal limits. Neurological exam was difficult to perform due to age and somnolence. Chest x-ray was normal, and cranial CAT scan was degraded due to motion, but no abnormal areas of increased attenuation, mass effect or shift of midline structures were seen to suggest an acute intracranial abnormality. Visualization of calvarium, adjacent para nasal sinuses, orbits and facial bones demonstrated no additional significant evidence of abnormality. Laboratory data in the emergency room revealed WBCs to be 22,700, hemoglobin 11.9, hematocrit 35.3, and platelets 294,999. Differential showed 61% segmented neutrophils, 2% bands, and 27% lymphocytes. Complete metabolic panel and urinalysis were normal. Blood cultures were taken, but results were not reported. The patient was admitted to the hospital for evaluation. History and physically performed on admission to the hospital revealed an active, alert, awake and happy patient with mild crusting of eyes. Lungs were clear bilaterally without wheezes. Assessment: 1) new onset seizure. It was unclear if fever was the etiology of the seizure as the grandmother reported the patient was hot/warm when she picked him up from his nap that day. There was no documentation of any fevers prior to the seizure episode, except for the low grade fever noted in the emergency room on arrival. It was unclear if the patient was having a fever prior to the seizure, of if the fever was due to the seizure. 2) Acute conjunctivitis on VIGAMOX. 3) Upper respiratory infection currently on ZYRTEC. 4) Leukocytosis that was unclear whether it was a result of stress margination from the seizure, or represented current viral upper respiratory infection. EEG was completed on day 2 of hospitalization that was normal without any evidence of epileptic, focal, or diffuse abnormalities. Discharge summary stated the patient had a temperature spike on the "9th" after admission of up to 102 degrees Fahrenheit with mild clear drainage that was persistent. On date of discharge (02 October 2010) the patient had almost complete resolution of acute conjunctivitis that had been noted the day prior to admission with 3 days remaining on VIGAMOX. Laboratory analysis on day of discharge showed CBC down with WBCs 18,000 from 22,000, hemoglobin 11.8, hematocrit 35.3, platelet count 215,000, 46% segmented neutrophils, 30% bands and 38% lymphocytes. Physical examination that day revealed continued clear nasal discharge and small amount of crusting around the right eye, however the sclera were clear with no active drainage. Impression was new onset seizure likely representing a febrile seizure and viral upper respiratory infection; however possibility of non-febrile acute seizure could not be ruled out although the normal EEG was reassuring. Follow-up neurology evaluation for baseline was recommended due to history of recurrent retinoblastoma. On day of discharge the mother was instructed to use TYLENOL or MOTRIN as needed for fever; and nasal saline for nasal drainage. The patient recovered and was discharged 02 October 2010. Discharge diagnosis was new onset seizure, upper respiratory infection, acute conjunctivitis and history of retinoblastoma. The patient was seen for follow-up in the physician's office for 04 October 2010 for prior hospitalization and seizure. That day the mother was also concerned about the patient's cough. Impression was that the cough and nasal drainage was residual findings from viral syndrome. The patient was to return for evaluation if the cough did not resolve by 07 October 2010. MRI of brain was scheduled and performed on 07 October 2010. The MRI was compared to prior study completed on 17 August 2010. There was asymmetric enhancement at the right optic disc and proximal optic nerve was seen compared to the left. The prior study had described a new small approximately 1 mm focus of enhancement of any T2 signal abnormalities, but there was a subtle difference in enhancement as described above. There was no evidence of a globular mass. The pineal gland appeared unremarkable. Small choroid plexes was noted bilaterally, but the remainder of the brain demonstrated normal signal intensity and morphology. There was no additional significant evidence of abnormality of the visualized facial and upper cervical spine. The patient subsequently received a third dose of FLUZONE, MMR, Varicella, and PCV vaccines on 28 October 2010; Hep B, IPV, and DTaP on 10 December 2010; and Hep B on 11 February 2011. Reason for second and third doses of FLUZONE vaccinations were not provided. Follow-up information was received 21 March 2011 from a health care professional. The patient had not received any other vaccines within four weeks of receiving FLUZONE and PENTACEL received on 16 September 2010. The patient had not experienced any adverse events following prior vaccinations. Pertaining to concomitant medications and concurrent illnesses, the reporter responded, "see attached note"; however, no note was received with the source documents. The patient's outcome remained not recovered. Documents held by sender: None.