Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Apparent life threatening event, Computerised tomogram normal, Convulsion, Diet refusal, Electroencephalogram normal
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of the physician. This nurse reported for a 4-month-old male patient who receive the second dose of PREVNAR 13 (Lot n. F45135, expiration date 01Mar2014) at 0.5 ml single, PENTACEL (Lot n. C4274AA, expiration date 14Mar2014) and ROTARIX (GlaxoSmithKline) (Lot n. A41FB289A, expiration date 06May2014) 1 ml orally, all administered on 08Sep2012 at 09.30. The relevant medical history included constipation since an unknown date from which the patient had recovered on an unknown date and gastroesophageal reflux disease (GERD) since an unknown date and ongoing, for which he started ZANTAC at 22.5 mg (oral) twice daily on 06 July 2012. The subject had no previous history of seizures or epilepsy, movement disorders, head injury, other CNS conditions, cerebral palsy, neurological handicap or congenital abnormality. Concurrent medical conditions included spitting up described as "expelling, formula" and vomiting. Relevant vaccine history included the first dose of PREVNAR 13 Lot n. F51336 i.m. on left thigh; PENTACEL Lot n. C4222AA i.m. on right thigh and oral ROTARIX Lot n. A41FB217A, all on 06Jul2012. The patient also received hepatitis vaccine (not specified) on 07May2012 and 06Jul2012. The healthcare professional reported that the subject had received routine pediatric vaccines at age 2 and 4 months of age. No adverse events were reported after the first vaccine. On 09Sep2012, the patient developed seizures (repetitive head turning, arm rigidity, refusal to eat, and blank stare into space) which the nurse elaborated as the patient had seizure without fever. The subject was reported to "turn his head to the right repeatedly" and refused to eat. While being changed his right arm became rigid and he "developed a blank stare". The episode lasted for about 20-30 seconds and was repeated a total of four times that morning. The subject was diagnosed with complex partial seizure disorder that was considered as a possible PENTACEL (pertussis) reaction. The seizure was witnessed and the subject lost consciousness. Due to this the patient was hospitalized for 2 days on 09Sep2012 and he was discharged on 11Sep2012 and there was no evidence of reason for the seizures. The relevant laboratory tests included: EEG: normal results on 10Sep2012 and 21Sep2012. CT, MRI: normal results on 09Sep2012, 20Sep2012, 21Sep2012: there was no evidence of neurological, lesion or infection and serum electrolytes were not abnormal. Blood labwork: normal results, except elevated acylcarnitine. Blood Cx (Unknown Date): normal results. The events was the first of multiple seizures requiring repeated ED visits, hospitalizations, PCP visits and specialist (neurology and genetics) visits. Patient is followed by a neurologist and a referral to genetics was made due to the elevated acylcarnitine levels. The patient continues to suffer from seizures of increasing complexity, duration and frequency. The subject was not on any medication known to reduce the seizure threshold; only after the seizure occurred was the subject placed on KEPPRA and TRILEPTAL. The subject continues to suffer from seizures. Vaccination series with ROTARIX, PENTACEL were discontinued. No action was taken with PREVNAR 13. The healthcare professional reported the subject was not scheduled to receive next series until 6-months of age, at the time of this report the subject was 5-months old. The healthcare professional reported that the etiology of the seizure disorder is still unknown. Follow-up attempts completed. No further information expected. Follow-up (08Nov2012): Follow-up attempts completed. No further information expected. Follow-up (13Nov2012): New information obtained from a contactable nurse reporting on behalf of the physician includes: previous vaccinations; laboratory data; and outcome. Follow-up (20Nov2012): New information received by Pfizer from GlaxoSmithKline (Manufacturing Report No. A0993287A) includes: patient's medical history and concurrent medical conditions, and details on the course and management of events. The loss of consciousness and refused to eat added as events, event afebrile seizure changed to complex partial seizures.